LayerRx Mapping ID
333
Slot System
Featured Buckets
Featured Buckets Admin
Reverse Chronological Sort

Recommendations from a gynecologic oncologist to a general ob.gyn., part 2

Article Type
Changed
Wed, 08/25/2021 - 07:43

In this month’s column we continue to discuss recommendations from the gynecologic oncologist to the general gynecologist.

Dr. Emma C. Rossi

Don’t screen average-risk women for ovarian cancer.

Ovarian cancer is most often diagnosed at an advanced stage, which limits the curability of the disease. Consequently, there is a strong focus on attempting to diagnose the disease at earlier, more curable stages. This leads to the impulse by some well-intentioned providers to implement screening tests, such as ultrasounds and tumor markers, for all women. Unfortunately, the screening of “average risk” women for ovarian cancer is not recommended. Randomized controlled trials of tens of thousands of women have not observed a clinically significant decrease in ovarian cancer mortality with the addition of screening with tumor markers and ultrasound.1 These studies did observe a false-positive rate of 5%. While that may seem like a low rate of false-positive testing, the definitive diagnostic test which follows is a major abdominal surgery (oophorectomy) and serious complications are encountered in 15% of patients undergoing surgery for false-positive ovarian cancer screening.1 Therefore, quite simply, the harms are not balanced by benefits.

The key to offering patients appropriate and effective screening is case selection. It is important to identify which patients are at higher risk for ovarian cancer and offer those women testing for germline mutations and screening strategies. An important component of a well-woman visit is to take a thorough family history of cancer. Women are considered at high risk for having hereditary predisposition to ovarian cancer if they have a first- or second-degree relative with breast cancer younger than 45-50 years, or any age if Ashkenazi Jewish, triple-negative breast cancer younger than 60 years of age, two or more primary breast cancers with the first diagnosed at less than 50 years of age, male breast cancer, ovarian cancer, pancreatic cancer, a known BRCA 1/2 mutation, or a personal history of those same conditions. These women should be recommended to undergo genetic testing for BRCA 1, 2, and Lynch syndrome. They should not automatically be offered ovarian cancer screening. If a patient has a more remote family history for ovarian cancer, their personal risk may be somewhat elevated above the baseline population risk, however, not substantially enough to justify implementing screening in the absence of a confirmed genetic mutation.

While screening tests may not be appropriate for all patients, all patients should be asked about the early symptoms of ovarian cancer because these are consistently present, and frequently overlooked, prior to the eventual diagnosis of advanced disease. Those symptoms include abdominal discomfort, abdominal swelling and bloating, and urinary urgency.2 Consider offering all patients a dedicated ovarian cancer specific review of systems that includes inquiries about these symptoms at their annual wellness visits.
 

Opt for vertical midline incisions when surgery is anticipated to be complex

What is the first thing gynecologic oncologists do when called in to assist in a difficult gynecologic procedure? Get better exposure. Exposure is the cornerstone of safe, effective surgery. Sometimes this simply means placing a more effective retractor. In other cases, it might mean extending the incision. However, if the incision is a low transverse incision (the go-to for many gynecologists because of its favorable cosmetic and pain-producing profile) this proves to be difficult. Attempting to assist in a complicated case, such as a frozen pelvis, severed ureter or rectal injury, through a pfannensteil incision can be extraordinarily difficult, and while these incisions can be extended by incising the rectus muscle bellies, upper abdominal visualization remains elusive in most patients. This is particularly problematic if the ureter or splenic flexure need to be mobilized, or if extensive lysis of adhesions is necessary to ensure there is no occult enterotomy. As my mentor Dr. John Soper once described to me: “It’s like trying to scratch your armpit by reaching through your fly.”

While pfannensteil incisions come naturally, and comfortably, to most gynecologists, likely because of their frequent application during cesarean section, all gynecologists should be confident in the steps and anatomy for vertical midline, or paramedian incisions. This is not only beneficial for complex gynecologic cases, but also in the event of vascular emergency. In the hands of an experienced abdominal/pelvic surgeon, the vertical midline incision is the quickest way to safely enter the abdomen, and provides the kind of exposure that may be critical in safely repairing or controlling hemorrhage from a major vessel.

While low transverse incisions may be more cosmetic, less painful, and associated with fewer wound complications, our first concern as surgeons should be mitigating complications. In situations where risks of complications are high, it is best to not handicap ourselves with the incision location. And always remember, wound complications are highest when a transverse incision needs to be converted to a vertical one with a “T.”
 

It’s not just about diagnosis of cancer, it’s also prevention

Detection of cancer is an important role of the obstetrician gynecologist. However, equally important is being able to seize opportunities for cancer prevention. Cervical, vulvar, endometrial and ovarian cancer are all known to have preventative strategies.

All patients up to the age of 45 should be offered vaccination against HPV. Initial indications for HPV vaccination were for women up to age 26; however, recent data support the safety and efficacy of the vaccine in older women.3 HPV vaccination is most effective at preventing cancer when administered prior to exposure (ideally age 9-11), leaving this in the hands of our pediatrician colleagues. However, we must be vigilant to inquire about vaccination status for all our patients and encourage vaccines for those who were missed earlier in their life.

Patients should be counseled regarding the significant risk reduction for cancer that is gained from use of oral hormonal contraceptives and progestin-releasing IUDs (especially for endometrial and ovarian cancers). Providing them with knowledge of this information when considering options for contraception or menstrual cycle management is important in their decision-making process.

Endometrial cancer incidence is sadly on the rise in the United States, likely secondary to increasing rates of obesity. Pregnancy is a time when many women begin to gain, and accumulate, weight and therefore obstetric providers have a unique opportunity to assist patients in strategies to normalize their weight after pregnancy. Many of my patients with endometrial cancer state that they have never heard that it is associated with obesity. This suggests that more can be done to educate patients on the carcinogenic effect of obesity (for both endometrial and breast cancer), which may aid in motivating change of modifiable behaviors.

The fallopian tubes are the source of many ovarian cancers and knowledge of this has led to the recommendation to perform opportunistic salpingectomy as a cancer risk-reducing strategy. Hysterectomy and sterilization procedures are most apropos for this modification. While prospective data to confirm a reduced risk of ovarian cancer with opportunistic salpingectomy are lacking, a reduced incidence of cancer has been observed when the tubes have been removed for indicated surgeries; there appear to be no significant deleterious sequelae.4,5 A focus should be made on removal of the entire distal third of the tube, particularly the fimbriated ends, as this is the portion most implicated in malignancy.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant disclosures. Contact her at [email protected].
 

References

1. Buys SS et al. JAMA. 2011;305(22):2295.

2. Goff BA et al. JAMA. 2004;291(22):2705.

3. Castellsagué X et al. Br J Cancer. 2011;105(1):28.

4. Yoon SH et al. Eur J Cancer. 2016 Mar;55:38-46.

5. Hanley GE et al. Am J Obstet Gynecol. 2018;219(2):172.

Publications
Topics
Sections

In this month’s column we continue to discuss recommendations from the gynecologic oncologist to the general gynecologist.

Dr. Emma C. Rossi

Don’t screen average-risk women for ovarian cancer.

Ovarian cancer is most often diagnosed at an advanced stage, which limits the curability of the disease. Consequently, there is a strong focus on attempting to diagnose the disease at earlier, more curable stages. This leads to the impulse by some well-intentioned providers to implement screening tests, such as ultrasounds and tumor markers, for all women. Unfortunately, the screening of “average risk” women for ovarian cancer is not recommended. Randomized controlled trials of tens of thousands of women have not observed a clinically significant decrease in ovarian cancer mortality with the addition of screening with tumor markers and ultrasound.1 These studies did observe a false-positive rate of 5%. While that may seem like a low rate of false-positive testing, the definitive diagnostic test which follows is a major abdominal surgery (oophorectomy) and serious complications are encountered in 15% of patients undergoing surgery for false-positive ovarian cancer screening.1 Therefore, quite simply, the harms are not balanced by benefits.

The key to offering patients appropriate and effective screening is case selection. It is important to identify which patients are at higher risk for ovarian cancer and offer those women testing for germline mutations and screening strategies. An important component of a well-woman visit is to take a thorough family history of cancer. Women are considered at high risk for having hereditary predisposition to ovarian cancer if they have a first- or second-degree relative with breast cancer younger than 45-50 years, or any age if Ashkenazi Jewish, triple-negative breast cancer younger than 60 years of age, two or more primary breast cancers with the first diagnosed at less than 50 years of age, male breast cancer, ovarian cancer, pancreatic cancer, a known BRCA 1/2 mutation, or a personal history of those same conditions. These women should be recommended to undergo genetic testing for BRCA 1, 2, and Lynch syndrome. They should not automatically be offered ovarian cancer screening. If a patient has a more remote family history for ovarian cancer, their personal risk may be somewhat elevated above the baseline population risk, however, not substantially enough to justify implementing screening in the absence of a confirmed genetic mutation.

While screening tests may not be appropriate for all patients, all patients should be asked about the early symptoms of ovarian cancer because these are consistently present, and frequently overlooked, prior to the eventual diagnosis of advanced disease. Those symptoms include abdominal discomfort, abdominal swelling and bloating, and urinary urgency.2 Consider offering all patients a dedicated ovarian cancer specific review of systems that includes inquiries about these symptoms at their annual wellness visits.
 

Opt for vertical midline incisions when surgery is anticipated to be complex

What is the first thing gynecologic oncologists do when called in to assist in a difficult gynecologic procedure? Get better exposure. Exposure is the cornerstone of safe, effective surgery. Sometimes this simply means placing a more effective retractor. In other cases, it might mean extending the incision. However, if the incision is a low transverse incision (the go-to for many gynecologists because of its favorable cosmetic and pain-producing profile) this proves to be difficult. Attempting to assist in a complicated case, such as a frozen pelvis, severed ureter or rectal injury, through a pfannensteil incision can be extraordinarily difficult, and while these incisions can be extended by incising the rectus muscle bellies, upper abdominal visualization remains elusive in most patients. This is particularly problematic if the ureter or splenic flexure need to be mobilized, or if extensive lysis of adhesions is necessary to ensure there is no occult enterotomy. As my mentor Dr. John Soper once described to me: “It’s like trying to scratch your armpit by reaching through your fly.”

While pfannensteil incisions come naturally, and comfortably, to most gynecologists, likely because of their frequent application during cesarean section, all gynecologists should be confident in the steps and anatomy for vertical midline, or paramedian incisions. This is not only beneficial for complex gynecologic cases, but also in the event of vascular emergency. In the hands of an experienced abdominal/pelvic surgeon, the vertical midline incision is the quickest way to safely enter the abdomen, and provides the kind of exposure that may be critical in safely repairing or controlling hemorrhage from a major vessel.

While low transverse incisions may be more cosmetic, less painful, and associated with fewer wound complications, our first concern as surgeons should be mitigating complications. In situations where risks of complications are high, it is best to not handicap ourselves with the incision location. And always remember, wound complications are highest when a transverse incision needs to be converted to a vertical one with a “T.”
 

It’s not just about diagnosis of cancer, it’s also prevention

Detection of cancer is an important role of the obstetrician gynecologist. However, equally important is being able to seize opportunities for cancer prevention. Cervical, vulvar, endometrial and ovarian cancer are all known to have preventative strategies.

All patients up to the age of 45 should be offered vaccination against HPV. Initial indications for HPV vaccination were for women up to age 26; however, recent data support the safety and efficacy of the vaccine in older women.3 HPV vaccination is most effective at preventing cancer when administered prior to exposure (ideally age 9-11), leaving this in the hands of our pediatrician colleagues. However, we must be vigilant to inquire about vaccination status for all our patients and encourage vaccines for those who were missed earlier in their life.

Patients should be counseled regarding the significant risk reduction for cancer that is gained from use of oral hormonal contraceptives and progestin-releasing IUDs (especially for endometrial and ovarian cancers). Providing them with knowledge of this information when considering options for contraception or menstrual cycle management is important in their decision-making process.

Endometrial cancer incidence is sadly on the rise in the United States, likely secondary to increasing rates of obesity. Pregnancy is a time when many women begin to gain, and accumulate, weight and therefore obstetric providers have a unique opportunity to assist patients in strategies to normalize their weight after pregnancy. Many of my patients with endometrial cancer state that they have never heard that it is associated with obesity. This suggests that more can be done to educate patients on the carcinogenic effect of obesity (for both endometrial and breast cancer), which may aid in motivating change of modifiable behaviors.

The fallopian tubes are the source of many ovarian cancers and knowledge of this has led to the recommendation to perform opportunistic salpingectomy as a cancer risk-reducing strategy. Hysterectomy and sterilization procedures are most apropos for this modification. While prospective data to confirm a reduced risk of ovarian cancer with opportunistic salpingectomy are lacking, a reduced incidence of cancer has been observed when the tubes have been removed for indicated surgeries; there appear to be no significant deleterious sequelae.4,5 A focus should be made on removal of the entire distal third of the tube, particularly the fimbriated ends, as this is the portion most implicated in malignancy.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant disclosures. Contact her at [email protected].
 

References

1. Buys SS et al. JAMA. 2011;305(22):2295.

2. Goff BA et al. JAMA. 2004;291(22):2705.

3. Castellsagué X et al. Br J Cancer. 2011;105(1):28.

4. Yoon SH et al. Eur J Cancer. 2016 Mar;55:38-46.

5. Hanley GE et al. Am J Obstet Gynecol. 2018;219(2):172.

In this month’s column we continue to discuss recommendations from the gynecologic oncologist to the general gynecologist.

Dr. Emma C. Rossi

Don’t screen average-risk women for ovarian cancer.

Ovarian cancer is most often diagnosed at an advanced stage, which limits the curability of the disease. Consequently, there is a strong focus on attempting to diagnose the disease at earlier, more curable stages. This leads to the impulse by some well-intentioned providers to implement screening tests, such as ultrasounds and tumor markers, for all women. Unfortunately, the screening of “average risk” women for ovarian cancer is not recommended. Randomized controlled trials of tens of thousands of women have not observed a clinically significant decrease in ovarian cancer mortality with the addition of screening with tumor markers and ultrasound.1 These studies did observe a false-positive rate of 5%. While that may seem like a low rate of false-positive testing, the definitive diagnostic test which follows is a major abdominal surgery (oophorectomy) and serious complications are encountered in 15% of patients undergoing surgery for false-positive ovarian cancer screening.1 Therefore, quite simply, the harms are not balanced by benefits.

The key to offering patients appropriate and effective screening is case selection. It is important to identify which patients are at higher risk for ovarian cancer and offer those women testing for germline mutations and screening strategies. An important component of a well-woman visit is to take a thorough family history of cancer. Women are considered at high risk for having hereditary predisposition to ovarian cancer if they have a first- or second-degree relative with breast cancer younger than 45-50 years, or any age if Ashkenazi Jewish, triple-negative breast cancer younger than 60 years of age, two or more primary breast cancers with the first diagnosed at less than 50 years of age, male breast cancer, ovarian cancer, pancreatic cancer, a known BRCA 1/2 mutation, or a personal history of those same conditions. These women should be recommended to undergo genetic testing for BRCA 1, 2, and Lynch syndrome. They should not automatically be offered ovarian cancer screening. If a patient has a more remote family history for ovarian cancer, their personal risk may be somewhat elevated above the baseline population risk, however, not substantially enough to justify implementing screening in the absence of a confirmed genetic mutation.

While screening tests may not be appropriate for all patients, all patients should be asked about the early symptoms of ovarian cancer because these are consistently present, and frequently overlooked, prior to the eventual diagnosis of advanced disease. Those symptoms include abdominal discomfort, abdominal swelling and bloating, and urinary urgency.2 Consider offering all patients a dedicated ovarian cancer specific review of systems that includes inquiries about these symptoms at their annual wellness visits.
 

Opt for vertical midline incisions when surgery is anticipated to be complex

What is the first thing gynecologic oncologists do when called in to assist in a difficult gynecologic procedure? Get better exposure. Exposure is the cornerstone of safe, effective surgery. Sometimes this simply means placing a more effective retractor. In other cases, it might mean extending the incision. However, if the incision is a low transverse incision (the go-to for many gynecologists because of its favorable cosmetic and pain-producing profile) this proves to be difficult. Attempting to assist in a complicated case, such as a frozen pelvis, severed ureter or rectal injury, through a pfannensteil incision can be extraordinarily difficult, and while these incisions can be extended by incising the rectus muscle bellies, upper abdominal visualization remains elusive in most patients. This is particularly problematic if the ureter or splenic flexure need to be mobilized, or if extensive lysis of adhesions is necessary to ensure there is no occult enterotomy. As my mentor Dr. John Soper once described to me: “It’s like trying to scratch your armpit by reaching through your fly.”

While pfannensteil incisions come naturally, and comfortably, to most gynecologists, likely because of their frequent application during cesarean section, all gynecologists should be confident in the steps and anatomy for vertical midline, or paramedian incisions. This is not only beneficial for complex gynecologic cases, but also in the event of vascular emergency. In the hands of an experienced abdominal/pelvic surgeon, the vertical midline incision is the quickest way to safely enter the abdomen, and provides the kind of exposure that may be critical in safely repairing or controlling hemorrhage from a major vessel.

While low transverse incisions may be more cosmetic, less painful, and associated with fewer wound complications, our first concern as surgeons should be mitigating complications. In situations where risks of complications are high, it is best to not handicap ourselves with the incision location. And always remember, wound complications are highest when a transverse incision needs to be converted to a vertical one with a “T.”
 

It’s not just about diagnosis of cancer, it’s also prevention

Detection of cancer is an important role of the obstetrician gynecologist. However, equally important is being able to seize opportunities for cancer prevention. Cervical, vulvar, endometrial and ovarian cancer are all known to have preventative strategies.

All patients up to the age of 45 should be offered vaccination against HPV. Initial indications for HPV vaccination were for women up to age 26; however, recent data support the safety and efficacy of the vaccine in older women.3 HPV vaccination is most effective at preventing cancer when administered prior to exposure (ideally age 9-11), leaving this in the hands of our pediatrician colleagues. However, we must be vigilant to inquire about vaccination status for all our patients and encourage vaccines for those who were missed earlier in their life.

Patients should be counseled regarding the significant risk reduction for cancer that is gained from use of oral hormonal contraceptives and progestin-releasing IUDs (especially for endometrial and ovarian cancers). Providing them with knowledge of this information when considering options for contraception or menstrual cycle management is important in their decision-making process.

Endometrial cancer incidence is sadly on the rise in the United States, likely secondary to increasing rates of obesity. Pregnancy is a time when many women begin to gain, and accumulate, weight and therefore obstetric providers have a unique opportunity to assist patients in strategies to normalize their weight after pregnancy. Many of my patients with endometrial cancer state that they have never heard that it is associated with obesity. This suggests that more can be done to educate patients on the carcinogenic effect of obesity (for both endometrial and breast cancer), which may aid in motivating change of modifiable behaviors.

The fallopian tubes are the source of many ovarian cancers and knowledge of this has led to the recommendation to perform opportunistic salpingectomy as a cancer risk-reducing strategy. Hysterectomy and sterilization procedures are most apropos for this modification. While prospective data to confirm a reduced risk of ovarian cancer with opportunistic salpingectomy are lacking, a reduced incidence of cancer has been observed when the tubes have been removed for indicated surgeries; there appear to be no significant deleterious sequelae.4,5 A focus should be made on removal of the entire distal third of the tube, particularly the fimbriated ends, as this is the portion most implicated in malignancy.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant disclosures. Contact her at [email protected].
 

References

1. Buys SS et al. JAMA. 2011;305(22):2295.

2. Goff BA et al. JAMA. 2004;291(22):2705.

3. Castellsagué X et al. Br J Cancer. 2011;105(1):28.

4. Yoon SH et al. Eur J Cancer. 2016 Mar;55:38-46.

5. Hanley GE et al. Am J Obstet Gynecol. 2018;219(2):172.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

A sizzling hybrid meeting of the Society of Gynecologic Surgeons

Article Type
Changed
Fri, 09/24/2021 - 15:25

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

Article PDF
Author and Disclosure Information

Dr. Schimpf is Associate Professor, Female Pelvic Medicine and Reconstructive Surgery, Departments of Obstetrics and Gynecology and Urology, University of Michigan, and Ambulatory Care Clinical Chief, Obstetrics and Gynecology, Ann Arbor, Michigan.

Issue
OBG Management - 33(8)
Publications
Topics
Page Number
SS2
Sections
Author and Disclosure Information

Dr. Schimpf is Associate Professor, Female Pelvic Medicine and Reconstructive Surgery, Departments of Obstetrics and Gynecology and Urology, University of Michigan, and Ambulatory Care Clinical Chief, Obstetrics and Gynecology, Ann Arbor, Michigan.

Author and Disclosure Information

Dr. Schimpf is Associate Professor, Female Pelvic Medicine and Reconstructive Surgery, Departments of Obstetrics and Gynecology and Urology, University of Michigan, and Ambulatory Care Clinical Chief, Obstetrics and Gynecology, Ann Arbor, Michigan.

Article PDF
Article PDF

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

Issue
OBG Management - 33(8)
Issue
OBG Management - 33(8)
Page Number
SS2
Page Number
SS2
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

A multidisciplinary approach to gyn care: A single center’s experience

Article Type
Changed
Fri, 09/24/2021 - 15:27

In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.1 Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.4 We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

 

 

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.5 Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.6

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.11 This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.12

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.13 In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

 

 

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.14 Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

 

 

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.17

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

References
  1. Ramaseshan AS, Felton J, Roque D, et al. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018;29:459-476.
  2. Nakayama N, Tsuji T, Aoyama M, et al. Quality of life and the prevalence of urinary incontinence after surgical treatment for gynecologic cancer: a questionnaire survey. BMC Womens Health. 2020;20:148-157.
  3. Cascales-Campos PA, Gonzalez-Gil A, Fernandez-Luna E, et al. Urinary and fecal incontinence in patients with advanced ovarian cancer treated with CRS + HIPEC. Surg Oncol. 2021;36:115-119.
  4. Davidson ER, Woodburn K, AlHilli M, et al. Perioperative adverse events in women undergoing concurrent urogynecologic and gynecologic oncology surgeries for suspected malignancy. Int Urogynecol J. 2019;30:1195-1201.
  5. Spence-Jones C, Kamm MA, Henry MM, et al. Bowel dysfunction: a pathogenic factor in uterovaginal prolapse and stress urinary incontinence. Br J Obstet Gynaecol. 1994;101:147-152.
  6. Thompson JR, Chen AH, Pettit PD, et al. Incidence of occult rectal prolapse in patients with clinical rectoceles and defecatory dysfunction. Am J Obstet Gynecol. 2002;187:1494-1500.
  7. Jallad K, Gurland B. Multidisciplinary approach to the treatment of concomitant rectal and vaginal prolapse. Clin Colon Rectal Surg. 2016;29:101-105.
  8. Kapoor DS, Sultan AH, Thakar R, et al. Management of complex pelvic floor disorders in a multidisciplinary pelvic floor clinic. Colorectal Dis. 2008;10:118-123.
  9. Weinberg D, Qeadan F, McKee R, et al. Safety of laparoscopic sacrocolpopexy with concurrent rectopexy: peri-operative morbidity in a nationwide cohort. Int Urogynecol J. 2019;30:385-392.
  10. Geltzeiler CB, Birnbaum EH, Silviera ML, et al. Combined rectopexy and sacrocolpopexy is safe for correction of pelvic organ prolapse. Int J Colorectal Dis. 2018;33:1453-1459.
  11. Wallace SL, Syan R, Enemchukwu EA, et al. Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery. Int Urogynecol J. 2020;31:2101-2108.
  12. Smith PE, Hade EM, Pandya LK, et al. Perioperative outcomes for combined ventral rectopexy with sacrocolpopexy compared to perineal rectopexy with vaginal apical suspension. Female Pelvic Med Reconstr Surg. 2020;26:376-381.
  13. Casas-Puig V, Bretschneider CE, Ferrando CA. Perioperative adverse events in women undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery. Female Pelvic Med Reconstr Surg. 2019;25:88-92.
  14. Cordeiro PG, Pusic AL, Disa JJ. A classification system and reconstructive algorithm for acquired vaginal defects. Plast Reconstr Surg. 2002;110:1058-1065.
  15. Lewicky-Gaupp C, Leader-Cramer A, Johnson LL, et al. Wound complications after obstetric anal sphincter injuries. Obstet Gynecol. 2015;125:1088-1093.
  16. Borello-France D, Burgio KL, Richter HE, et al; Pelvic Floor Disorders Network. Fecal and urinary incontinence in primiparous women. Obstet Gynecol. 2006;108:863-872.
  17. Propst K, Hickman LC. Peripartum pelvic floor disorder clinics inform obstetric provider practices. Int Urogynecol J. 2021;32:1793-1799.
Article PDF
Author and Disclosure Information

Cecile A. Ferrando, MD, MPH

Associate Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio.

Katie Propst, MD

Urogynecologist, Assistant Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio

 

Dr. Ferrando reports receiving royalties from UpToDate, Inc. Dr. Propst reports no financial relationships relevant to this article.

Issue
OBG Management - 33(8)
Publications
Topics
Page Number
SS3-SS6, SS8
Sections
Author and Disclosure Information

Cecile A. Ferrando, MD, MPH

Associate Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio.

Katie Propst, MD

Urogynecologist, Assistant Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio

 

Dr. Ferrando reports receiving royalties from UpToDate, Inc. Dr. Propst reports no financial relationships relevant to this article.

Author and Disclosure Information

Cecile A. Ferrando, MD, MPH

Associate Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio.

Katie Propst, MD

Urogynecologist, Assistant Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio

 

Dr. Ferrando reports receiving royalties from UpToDate, Inc. Dr. Propst reports no financial relationships relevant to this article.

Article PDF
Article PDF

In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.1 Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.4 We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

 

 

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.5 Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.6

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.11 This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.12

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.13 In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

 

 

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.14 Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

 

 

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.17

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.1 Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.4 We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

 

 

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.5 Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.6

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.11 This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.12

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.13 In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

 

 

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.14 Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

 

 

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.17

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

References
  1. Ramaseshan AS, Felton J, Roque D, et al. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018;29:459-476.
  2. Nakayama N, Tsuji T, Aoyama M, et al. Quality of life and the prevalence of urinary incontinence after surgical treatment for gynecologic cancer: a questionnaire survey. BMC Womens Health. 2020;20:148-157.
  3. Cascales-Campos PA, Gonzalez-Gil A, Fernandez-Luna E, et al. Urinary and fecal incontinence in patients with advanced ovarian cancer treated with CRS + HIPEC. Surg Oncol. 2021;36:115-119.
  4. Davidson ER, Woodburn K, AlHilli M, et al. Perioperative adverse events in women undergoing concurrent urogynecologic and gynecologic oncology surgeries for suspected malignancy. Int Urogynecol J. 2019;30:1195-1201.
  5. Spence-Jones C, Kamm MA, Henry MM, et al. Bowel dysfunction: a pathogenic factor in uterovaginal prolapse and stress urinary incontinence. Br J Obstet Gynaecol. 1994;101:147-152.
  6. Thompson JR, Chen AH, Pettit PD, et al. Incidence of occult rectal prolapse in patients with clinical rectoceles and defecatory dysfunction. Am J Obstet Gynecol. 2002;187:1494-1500.
  7. Jallad K, Gurland B. Multidisciplinary approach to the treatment of concomitant rectal and vaginal prolapse. Clin Colon Rectal Surg. 2016;29:101-105.
  8. Kapoor DS, Sultan AH, Thakar R, et al. Management of complex pelvic floor disorders in a multidisciplinary pelvic floor clinic. Colorectal Dis. 2008;10:118-123.
  9. Weinberg D, Qeadan F, McKee R, et al. Safety of laparoscopic sacrocolpopexy with concurrent rectopexy: peri-operative morbidity in a nationwide cohort. Int Urogynecol J. 2019;30:385-392.
  10. Geltzeiler CB, Birnbaum EH, Silviera ML, et al. Combined rectopexy and sacrocolpopexy is safe for correction of pelvic organ prolapse. Int J Colorectal Dis. 2018;33:1453-1459.
  11. Wallace SL, Syan R, Enemchukwu EA, et al. Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery. Int Urogynecol J. 2020;31:2101-2108.
  12. Smith PE, Hade EM, Pandya LK, et al. Perioperative outcomes for combined ventral rectopexy with sacrocolpopexy compared to perineal rectopexy with vaginal apical suspension. Female Pelvic Med Reconstr Surg. 2020;26:376-381.
  13. Casas-Puig V, Bretschneider CE, Ferrando CA. Perioperative adverse events in women undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery. Female Pelvic Med Reconstr Surg. 2019;25:88-92.
  14. Cordeiro PG, Pusic AL, Disa JJ. A classification system and reconstructive algorithm for acquired vaginal defects. Plast Reconstr Surg. 2002;110:1058-1065.
  15. Lewicky-Gaupp C, Leader-Cramer A, Johnson LL, et al. Wound complications after obstetric anal sphincter injuries. Obstet Gynecol. 2015;125:1088-1093.
  16. Borello-France D, Burgio KL, Richter HE, et al; Pelvic Floor Disorders Network. Fecal and urinary incontinence in primiparous women. Obstet Gynecol. 2006;108:863-872.
  17. Propst K, Hickman LC. Peripartum pelvic floor disorder clinics inform obstetric provider practices. Int Urogynecol J. 2021;32:1793-1799.
References
  1. Ramaseshan AS, Felton J, Roque D, et al. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018;29:459-476.
  2. Nakayama N, Tsuji T, Aoyama M, et al. Quality of life and the prevalence of urinary incontinence after surgical treatment for gynecologic cancer: a questionnaire survey. BMC Womens Health. 2020;20:148-157.
  3. Cascales-Campos PA, Gonzalez-Gil A, Fernandez-Luna E, et al. Urinary and fecal incontinence in patients with advanced ovarian cancer treated with CRS + HIPEC. Surg Oncol. 2021;36:115-119.
  4. Davidson ER, Woodburn K, AlHilli M, et al. Perioperative adverse events in women undergoing concurrent urogynecologic and gynecologic oncology surgeries for suspected malignancy. Int Urogynecol J. 2019;30:1195-1201.
  5. Spence-Jones C, Kamm MA, Henry MM, et al. Bowel dysfunction: a pathogenic factor in uterovaginal prolapse and stress urinary incontinence. Br J Obstet Gynaecol. 1994;101:147-152.
  6. Thompson JR, Chen AH, Pettit PD, et al. Incidence of occult rectal prolapse in patients with clinical rectoceles and defecatory dysfunction. Am J Obstet Gynecol. 2002;187:1494-1500.
  7. Jallad K, Gurland B. Multidisciplinary approach to the treatment of concomitant rectal and vaginal prolapse. Clin Colon Rectal Surg. 2016;29:101-105.
  8. Kapoor DS, Sultan AH, Thakar R, et al. Management of complex pelvic floor disorders in a multidisciplinary pelvic floor clinic. Colorectal Dis. 2008;10:118-123.
  9. Weinberg D, Qeadan F, McKee R, et al. Safety of laparoscopic sacrocolpopexy with concurrent rectopexy: peri-operative morbidity in a nationwide cohort. Int Urogynecol J. 2019;30:385-392.
  10. Geltzeiler CB, Birnbaum EH, Silviera ML, et al. Combined rectopexy and sacrocolpopexy is safe for correction of pelvic organ prolapse. Int J Colorectal Dis. 2018;33:1453-1459.
  11. Wallace SL, Syan R, Enemchukwu EA, et al. Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery. Int Urogynecol J. 2020;31:2101-2108.
  12. Smith PE, Hade EM, Pandya LK, et al. Perioperative outcomes for combined ventral rectopexy with sacrocolpopexy compared to perineal rectopexy with vaginal apical suspension. Female Pelvic Med Reconstr Surg. 2020;26:376-381.
  13. Casas-Puig V, Bretschneider CE, Ferrando CA. Perioperative adverse events in women undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery. Female Pelvic Med Reconstr Surg. 2019;25:88-92.
  14. Cordeiro PG, Pusic AL, Disa JJ. A classification system and reconstructive algorithm for acquired vaginal defects. Plast Reconstr Surg. 2002;110:1058-1065.
  15. Lewicky-Gaupp C, Leader-Cramer A, Johnson LL, et al. Wound complications after obstetric anal sphincter injuries. Obstet Gynecol. 2015;125:1088-1093.
  16. Borello-France D, Burgio KL, Richter HE, et al; Pelvic Floor Disorders Network. Fecal and urinary incontinence in primiparous women. Obstet Gynecol. 2006;108:863-872.
  17. Propst K, Hickman LC. Peripartum pelvic floor disorder clinics inform obstetric provider practices. Int Urogynecol J. 2021;32:1793-1799.
Issue
OBG Management - 33(8)
Issue
OBG Management - 33(8)
Page Number
SS3-SS6, SS8
Page Number
SS3-SS6, SS8
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

Mayo Clinic again named best hospital in U.S. for gynecology

Article Type
Changed
Tue, 07/27/2021 - 15:43

 

This year, the Mayo Clinic, Rochester, Minn. again ranked as the top hospital for gynecology, according to U.S. News and World Report, which released its annual rankings today.

The top five hospitals for gynecology were the same this year and were in the same order. In second place again this year was Memorial Sloan Kettering Cancer Center, New York, followed by the Cleveland Clinic, Brigham and Women’s Hospital, Boston, and the University of Texas MD Anderson Cancer Center, Houston.

Rounding out the top 10 were (6) Inova Fairfax Hospital, Falls Church, Virginia; (7) the University of Alabama at Birmingham Hospital; (8) Johns Hopkins Hospital, Baltimore, Maryland; and Massachusetts General Hospital, Boston, and Stanford Health Care–Stanford Hospital, Palo Alto, California, which tied for the ninth spot.

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

In 12 of the specialties, including gynecology, rankings are determined by a data-driven analysis that combines performance measures in structure, process, and outcomes. Rankings in three other specialties – ophthalmology, psychiatry, and rheumatology – rely on expert opinion alone, according to the U.S. News methodology report.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again no. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release.

In other top specialties, the University of Texas MD Anderson Cancer Center ranked no. 1 in cancer; the Cleveland Clinic is no. 1 in cardiology and heart surgery; and the Hospital for Special Surgery, New York, is no. 1 in orthopedics.

A full list of rankings is available on the magazine’s website.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

 

This year, the Mayo Clinic, Rochester, Minn. again ranked as the top hospital for gynecology, according to U.S. News and World Report, which released its annual rankings today.

The top five hospitals for gynecology were the same this year and were in the same order. In second place again this year was Memorial Sloan Kettering Cancer Center, New York, followed by the Cleveland Clinic, Brigham and Women’s Hospital, Boston, and the University of Texas MD Anderson Cancer Center, Houston.

Rounding out the top 10 were (6) Inova Fairfax Hospital, Falls Church, Virginia; (7) the University of Alabama at Birmingham Hospital; (8) Johns Hopkins Hospital, Baltimore, Maryland; and Massachusetts General Hospital, Boston, and Stanford Health Care–Stanford Hospital, Palo Alto, California, which tied for the ninth spot.

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

In 12 of the specialties, including gynecology, rankings are determined by a data-driven analysis that combines performance measures in structure, process, and outcomes. Rankings in three other specialties – ophthalmology, psychiatry, and rheumatology – rely on expert opinion alone, according to the U.S. News methodology report.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again no. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release.

In other top specialties, the University of Texas MD Anderson Cancer Center ranked no. 1 in cancer; the Cleveland Clinic is no. 1 in cardiology and heart surgery; and the Hospital for Special Surgery, New York, is no. 1 in orthopedics.

A full list of rankings is available on the magazine’s website.

A version of this article first appeared on Medscape.com.

 

This year, the Mayo Clinic, Rochester, Minn. again ranked as the top hospital for gynecology, according to U.S. News and World Report, which released its annual rankings today.

The top five hospitals for gynecology were the same this year and were in the same order. In second place again this year was Memorial Sloan Kettering Cancer Center, New York, followed by the Cleveland Clinic, Brigham and Women’s Hospital, Boston, and the University of Texas MD Anderson Cancer Center, Houston.

Rounding out the top 10 were (6) Inova Fairfax Hospital, Falls Church, Virginia; (7) the University of Alabama at Birmingham Hospital; (8) Johns Hopkins Hospital, Baltimore, Maryland; and Massachusetts General Hospital, Boston, and Stanford Health Care–Stanford Hospital, Palo Alto, California, which tied for the ninth spot.

U.S. News compared more than 4,750 medical centers nationwide in 15 specialties. Of those, 531 were recognized as Best Regional Hospitals on the basis of their strong performance in multiple areas of care.

In 12 of the specialties, including gynecology, rankings are determined by a data-driven analysis that combines performance measures in structure, process, and outcomes. Rankings in three other specialties – ophthalmology, psychiatry, and rheumatology – rely on expert opinion alone, according to the U.S. News methodology report.

The top 20 hospitals overall were also named to the Honor Roll.

Mayo Clinic was again no. 1 on the honor roll, a ranking it has held for 6 years in a row, according to a press release.

In other top specialties, the University of Texas MD Anderson Cancer Center ranked no. 1 in cancer; the Cleveland Clinic is no. 1 in cardiology and heart surgery; and the Hospital for Special Surgery, New York, is no. 1 in orthopedics.

A full list of rankings is available on the magazine’s website.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Laparoscopic abdominal cerclage: An effective, patient-sought approach for cervical insufficiency

Article Type
Changed
Tue, 07/27/2021 - 16:13

Cervical insufficiency is an important cause of preterm birth and complicates up to 1% of pregnancies. It is typically diagnosed as painless cervical dilation without contractions, often in the second trimester at around 16-18 weeks, but the clinical presentation can be variable. In some cases, a rescue cerclage can be placed to prevent second trimester loss or preterm birth.

Dr. Jon I. Einarsson

A recent landmark randomized controlled trial of abdominal vs. vaginal cerclage – the MAVRIC trial (Multicentre Abdominal vs. Vaginal Randomized Intervention of Cerclage)1 published in 2020 – has offered significant validation for the belief that an abdominal approach is the preferred approach for patients with cervical insufficiency and a prior failed vaginal cerclage.

Obstetricians traditionally have had a high threshold for placement of an abdominal cerclage given the need for cesarean delivery and the morbidity of an open procedure. Laparoscopic abdominal cerclage has lowered this threshold and is increasingly the preferred method for cerclage placement. Reported complication rates are generally lower than for open abdominal cerclage, and neonatal survival rates are similar or improved.

In our experience, the move toward laparoscopic abdominal cerclage is largely a patient-driven shift. Since 2007, at Brigham and Women’s Hospital in Boston, we have performed over 150 laparoscopic abdominal cerclage placements. The majority of patients had at least one prior second-trimester loss (many of them had multiple losses), with many having also failed a transvaginal cerclage.

In an analysis of 137 of these cases published recently in Fertility and Sterility, the neonatal survival rate was 93.8% in the 80 pregnancies that followed and extended beyond the first trimester, and the mean gestational age at delivery was 36.9 weeks.2 (First trimester losses are typically excluded from the denominator because they are unlikely to be the result of cervical insufficiency.)

History and outcomes data

The vaginal cerclage has long been a mainstay of therapy because it is a simple procedure. The McDonald technique, described in the 1950s, uses a simple purse string suture at the cervico-vaginal juncture, and the Shirodkar approach, also described in the 1950s, involves placing the cerclage higher on the cervix, as close to the internal os as possible. The Shirodkar technique is more complex, requiring more dissection, and is used less often than the McDonald approach.

The abdominal cerclage, first reported in 1965,3 is placed higher on the cervix, right near the juncture of the lower uterine segment and the cervix, and has generally been thought to provide optimal integrity. It is this point of placement – right at the juncture where membranes begin protruding into the cervix as it shortens and softens – that offers the strongest defense against cervical insufficiency.

The laparoscopic abdominal approach has been gaining popularity since it was first reported in 1998.4 Its traditional indication has been after a prior failed vaginal cerclage or when the cervix is too short to place a vaginal cerclage – as a result of a congenital anomaly or cervical conization, for instance.

Some of my patients have had one pregnancy loss in which cervical insufficiency was suspected and have sought laparoscopic abdominal cerclage without attempting a vaginal cerclage. Data to support this scenario are unavailable, but given the psychological trauma of pregnancy loss and the minimally invasive and low-risk nature of laparoscopic abdominal cerclage, I have been inclined to agree to preventive laparoscopic abdominal procedures without a trial of a vaginal cerclage. I believe this is a reasonable option.

The recently published MAVRIC trial included only abdominal cerclages performed using an open approach, but it provides good data for the scenario in which a vaginal cerclage has failed.

The rates of preterm birth at less than 32 weeks were significantly lower with abdominal cerclage than with low vaginal cerclage (McDonald technique) or high vaginal cerclage (Shirodkar technique) (8% vs. 33%, and 8% vs. 38%). No neonatal deaths occurred.

The analysis covered 111 women who conceived and had known pregnancy outcomes, out of 139 who were recruited and randomized. Cerclage placement occurred either between 10 and 16 weeks of gestation for vaginal cerclages and at 14 weeks for abdominal cerclages or before conception for those assigned to receive an abdominal or high vaginal cerclage.

Reviews of the literature done by our group1 and others have found equivalent outcomes between abdominal cerclages placed through laparotomy and through laparoscopy. The largest systematic review analyzed 31 studies involving 1,844 patients and found that neonatal survival rates were significantly greater in the laparoscopic group (97% vs. 90%), as were rates of deliveries after 34 weeks of gestation (83% vs. 76%).5

The better outcomes in the laparoscopic group may at least partly reflect improved laparoscopic surgeon techniques and improvements in neonatal care over time. At the minimum, we can conclude that neonatal outcomes are at least equivalent when an abdominal cerclage is placed through laparotomy or with a minimally invasive approach.

 

 

Our technique

Laparoscopic cerclages are much more easily placed – and with less risk of surgical complications or blood loss – in patients who are not pregnant. Postconception cerclage placement also carries a unique, small risk of fetal loss (estimated to occur in 1.2% of laparoscopic cases and 3% of open cases). 1 We therefore prefer to perform the procedure before pregnancy, though we do place abdominal cerclages in early pregnancy as well. (Approximately 10% of the 137 patients in our analysis were pregnant at the time of cerclage placement. 1 )

The procedure, described here for the nonpregnant patient, typically requires 3-4 ports. My preference is to use a 10-mm scope at the umbilicus, two 5-mm ipsilateral ports, and an additional 5-mm port for my assistant. We generally use a uterine manipulator to help with dissection and facilitate the correct angulation of the suture needle.

Dr. Jon I. Einarsson
Fig 1. Dissection of the vesicouterine peritoneum. The uterine arteries are indicated by white arrows.


We start by opening the vesicouterine peritoneum to dissect the uterine arteries anteriorly and to move the bladder slightly caudad. It is not a significant dissection.

For suturing, we use 5-mm Mersilene polyester tape with blunt-tip needles – the same tape that is commonly used for vaginal cerclages. The needles (which probably are unnecessarily long for laparoscopic cerclages) are straightened out prior to insertion with robust needle holders.

Dr. Jon I. Einarsson
Fig 2. Initial placement of the first needle on the right. The uterine artery is indicated with a red arrow, the ureter with a white arrow, and the site of the insertion of the left needle is shown with a blue dot.


The posterior broad ligament is not opened prior to insertion of the needle, as opening the broad ligament risks possible vessel injury and adds complexity.

Dr. Jon I. Einarsson
Fig 3. Twisting the uterus with the uterine manipulator enables the surgeon to better visualize the correct path of the needle placement.

Direct insertion of the needle simplifies the procedure and has not led to any complications thus far.

We prefer to insert the suture posteriorly at the level of the internal os just above the insertion of the uterosacral ligaments. It is helpful to view the uterus and cervix as an hourglass, with the level of the internal os is at the narrowest point of the hourglass.

The suture is passed carefully between the uterine vessels and the cervical stroma. The uterine artery should be lateral to placement of the needle, and the uterosacral ligament should be below. The surgeon should see a pulsation of the uterine artery. The use of blunt needles is advantageous because, especially when newer to the procedure, the surgeon can place the needle in slightly more medial than may be deemed necessary so as to avert the uterine vessels, then adjust placement slightly more laterally if resistance is met.

Suture placement should follow a fairly low-impact path. Encountering too much resistance with the needle signals passage into the cervix and necessitates redirection of the needle with a slightly more lateral placement. Twisting the uterus with the uterine manipulator can be helpful throughout this process.

Once the needles are passed through, they are cut off the Mersilene tape and removed. For suturing, it’s important that the first and second knots are tied down snuggly and flat.

Dr. Jon I. Einarsson
Fig 4. The first knot has been tied down.

I usually ask my assistant to hold down the first knot so that it doesn’t unravel while I tie the second knot. I usually tie 6 square knots with the tape.

Dr. Jon I. Einarsson
Fig 5. All knots have been tied down.

The edges of the tape are then trimmed, and with a 2.0 silk suture, the ends are secured to the lower uterine segment to prevent a theoretical risk of erosion into the bladder.

Dr. Jon I. Einarsson
Fig 6. The ends of the mersilene tape have been tied down with silk suture.

We then close the overlying vesicouterine peritoneum with 2-0 Monocryl suture, tying it intracorporally. Closing the peritoneum posteriorly is generally not necessary.

Dr. Jon I. Einarsson
Fig 7. The vesicouterine peritoneum has been closed


We have not had significant bleeding or severe complications in any of our cases. And while the literature comparing preconception and postconception abdominal cerclage is limited, the risks appear very low especially before pregnancy. Some oozing from the uterine vein can sometimes occur; if this does not resolve once it is tied down, placement of a simple figure of eight suture such as a Monocryl or Vicryl at the posterior insertion of the tape may be necessary to stop the bleeding.

Some surgeons place the abdominal cerclage lateral to the uterine artery, presumably to lessen any risk of vessel injury, but again, our placement medial to the vessels has not led to any significant bleeding. By doing so we are averting a theoretical risk with lateral placement of possibly constricting blood flow to the uterus during pregnancy.

Another technique for suturing that has been described uses a fascial closing device, which, after the needles are removed, passes between the vessels and cervix anteriorly and grasps each end of the suture posteriorly before pulling it through the cervix. My concern with this approach is that entry into the cervix with this device’s sharp needles could cause erosion of the tape into the cervical canal. Piercing of a vessel could also cause bleeding.

Laparoscopic abdominal cerclage can also be placed with robotic assistance, but I don’t believe that the robot offers any benefit for this relatively short, uncomplicated procedure.

A note on patient care

We recommend that patients not become pregnant for 2 months after the laparoscopic abdominal cerclage is placed, and that they receive obstetrical care as high-risk patients. The cerclage can be removed at the time of cesarean delivery if the patient has completed childbearing. Otherwise, if the cerclage appears normal, it can be left in place for future pregnancies.

In the event of a miscarriage, a dilatation and evacuation procedure can be performed with an abdominal cerclage in place, up to 18 weeks of pregnancy. Beyond this point, the patient likely will need to have the cerclage removed laparoscopically to allow vaginal passing of the fetus.

References

1. Shennan A et al. Am J Obstet Gynecol. 2020;222(3):261.E1-261.E9.

2. Clark NV & Einarsson JI. Fertil Steril. 2020;113:717-22.

3. Benson RC & Durfee RB. Obstet Gynecol. 1965;25:145-55.

4. Lesser KB et al. Obstet Gynecol. 1998;91:855-6.

5. Moawad GN et al. J Minim Invasive Gynecol. 2018;25:277-86.
 

Publications
Topics
Sections

Cervical insufficiency is an important cause of preterm birth and complicates up to 1% of pregnancies. It is typically diagnosed as painless cervical dilation without contractions, often in the second trimester at around 16-18 weeks, but the clinical presentation can be variable. In some cases, a rescue cerclage can be placed to prevent second trimester loss or preterm birth.

Dr. Jon I. Einarsson

A recent landmark randomized controlled trial of abdominal vs. vaginal cerclage – the MAVRIC trial (Multicentre Abdominal vs. Vaginal Randomized Intervention of Cerclage)1 published in 2020 – has offered significant validation for the belief that an abdominal approach is the preferred approach for patients with cervical insufficiency and a prior failed vaginal cerclage.

Obstetricians traditionally have had a high threshold for placement of an abdominal cerclage given the need for cesarean delivery and the morbidity of an open procedure. Laparoscopic abdominal cerclage has lowered this threshold and is increasingly the preferred method for cerclage placement. Reported complication rates are generally lower than for open abdominal cerclage, and neonatal survival rates are similar or improved.

In our experience, the move toward laparoscopic abdominal cerclage is largely a patient-driven shift. Since 2007, at Brigham and Women’s Hospital in Boston, we have performed over 150 laparoscopic abdominal cerclage placements. The majority of patients had at least one prior second-trimester loss (many of them had multiple losses), with many having also failed a transvaginal cerclage.

In an analysis of 137 of these cases published recently in Fertility and Sterility, the neonatal survival rate was 93.8% in the 80 pregnancies that followed and extended beyond the first trimester, and the mean gestational age at delivery was 36.9 weeks.2 (First trimester losses are typically excluded from the denominator because they are unlikely to be the result of cervical insufficiency.)

History and outcomes data

The vaginal cerclage has long been a mainstay of therapy because it is a simple procedure. The McDonald technique, described in the 1950s, uses a simple purse string suture at the cervico-vaginal juncture, and the Shirodkar approach, also described in the 1950s, involves placing the cerclage higher on the cervix, as close to the internal os as possible. The Shirodkar technique is more complex, requiring more dissection, and is used less often than the McDonald approach.

The abdominal cerclage, first reported in 1965,3 is placed higher on the cervix, right near the juncture of the lower uterine segment and the cervix, and has generally been thought to provide optimal integrity. It is this point of placement – right at the juncture where membranes begin protruding into the cervix as it shortens and softens – that offers the strongest defense against cervical insufficiency.

The laparoscopic abdominal approach has been gaining popularity since it was first reported in 1998.4 Its traditional indication has been after a prior failed vaginal cerclage or when the cervix is too short to place a vaginal cerclage – as a result of a congenital anomaly or cervical conization, for instance.

Some of my patients have had one pregnancy loss in which cervical insufficiency was suspected and have sought laparoscopic abdominal cerclage without attempting a vaginal cerclage. Data to support this scenario are unavailable, but given the psychological trauma of pregnancy loss and the minimally invasive and low-risk nature of laparoscopic abdominal cerclage, I have been inclined to agree to preventive laparoscopic abdominal procedures without a trial of a vaginal cerclage. I believe this is a reasonable option.

The recently published MAVRIC trial included only abdominal cerclages performed using an open approach, but it provides good data for the scenario in which a vaginal cerclage has failed.

The rates of preterm birth at less than 32 weeks were significantly lower with abdominal cerclage than with low vaginal cerclage (McDonald technique) or high vaginal cerclage (Shirodkar technique) (8% vs. 33%, and 8% vs. 38%). No neonatal deaths occurred.

The analysis covered 111 women who conceived and had known pregnancy outcomes, out of 139 who were recruited and randomized. Cerclage placement occurred either between 10 and 16 weeks of gestation for vaginal cerclages and at 14 weeks for abdominal cerclages or before conception for those assigned to receive an abdominal or high vaginal cerclage.

Reviews of the literature done by our group1 and others have found equivalent outcomes between abdominal cerclages placed through laparotomy and through laparoscopy. The largest systematic review analyzed 31 studies involving 1,844 patients and found that neonatal survival rates were significantly greater in the laparoscopic group (97% vs. 90%), as were rates of deliveries after 34 weeks of gestation (83% vs. 76%).5

The better outcomes in the laparoscopic group may at least partly reflect improved laparoscopic surgeon techniques and improvements in neonatal care over time. At the minimum, we can conclude that neonatal outcomes are at least equivalent when an abdominal cerclage is placed through laparotomy or with a minimally invasive approach.

 

 

Our technique

Laparoscopic cerclages are much more easily placed – and with less risk of surgical complications or blood loss – in patients who are not pregnant. Postconception cerclage placement also carries a unique, small risk of fetal loss (estimated to occur in 1.2% of laparoscopic cases and 3% of open cases). 1 We therefore prefer to perform the procedure before pregnancy, though we do place abdominal cerclages in early pregnancy as well. (Approximately 10% of the 137 patients in our analysis were pregnant at the time of cerclage placement. 1 )

The procedure, described here for the nonpregnant patient, typically requires 3-4 ports. My preference is to use a 10-mm scope at the umbilicus, two 5-mm ipsilateral ports, and an additional 5-mm port for my assistant. We generally use a uterine manipulator to help with dissection and facilitate the correct angulation of the suture needle.

Dr. Jon I. Einarsson
Fig 1. Dissection of the vesicouterine peritoneum. The uterine arteries are indicated by white arrows.


We start by opening the vesicouterine peritoneum to dissect the uterine arteries anteriorly and to move the bladder slightly caudad. It is not a significant dissection.

For suturing, we use 5-mm Mersilene polyester tape with blunt-tip needles – the same tape that is commonly used for vaginal cerclages. The needles (which probably are unnecessarily long for laparoscopic cerclages) are straightened out prior to insertion with robust needle holders.

Dr. Jon I. Einarsson
Fig 2. Initial placement of the first needle on the right. The uterine artery is indicated with a red arrow, the ureter with a white arrow, and the site of the insertion of the left needle is shown with a blue dot.


The posterior broad ligament is not opened prior to insertion of the needle, as opening the broad ligament risks possible vessel injury and adds complexity.

Dr. Jon I. Einarsson
Fig 3. Twisting the uterus with the uterine manipulator enables the surgeon to better visualize the correct path of the needle placement.

Direct insertion of the needle simplifies the procedure and has not led to any complications thus far.

We prefer to insert the suture posteriorly at the level of the internal os just above the insertion of the uterosacral ligaments. It is helpful to view the uterus and cervix as an hourglass, with the level of the internal os is at the narrowest point of the hourglass.

The suture is passed carefully between the uterine vessels and the cervical stroma. The uterine artery should be lateral to placement of the needle, and the uterosacral ligament should be below. The surgeon should see a pulsation of the uterine artery. The use of blunt needles is advantageous because, especially when newer to the procedure, the surgeon can place the needle in slightly more medial than may be deemed necessary so as to avert the uterine vessels, then adjust placement slightly more laterally if resistance is met.

Suture placement should follow a fairly low-impact path. Encountering too much resistance with the needle signals passage into the cervix and necessitates redirection of the needle with a slightly more lateral placement. Twisting the uterus with the uterine manipulator can be helpful throughout this process.

Once the needles are passed through, they are cut off the Mersilene tape and removed. For suturing, it’s important that the first and second knots are tied down snuggly and flat.

Dr. Jon I. Einarsson
Fig 4. The first knot has been tied down.

I usually ask my assistant to hold down the first knot so that it doesn’t unravel while I tie the second knot. I usually tie 6 square knots with the tape.

Dr. Jon I. Einarsson
Fig 5. All knots have been tied down.

The edges of the tape are then trimmed, and with a 2.0 silk suture, the ends are secured to the lower uterine segment to prevent a theoretical risk of erosion into the bladder.

Dr. Jon I. Einarsson
Fig 6. The ends of the mersilene tape have been tied down with silk suture.

We then close the overlying vesicouterine peritoneum with 2-0 Monocryl suture, tying it intracorporally. Closing the peritoneum posteriorly is generally not necessary.

Dr. Jon I. Einarsson
Fig 7. The vesicouterine peritoneum has been closed


We have not had significant bleeding or severe complications in any of our cases. And while the literature comparing preconception and postconception abdominal cerclage is limited, the risks appear very low especially before pregnancy. Some oozing from the uterine vein can sometimes occur; if this does not resolve once it is tied down, placement of a simple figure of eight suture such as a Monocryl or Vicryl at the posterior insertion of the tape may be necessary to stop the bleeding.

Some surgeons place the abdominal cerclage lateral to the uterine artery, presumably to lessen any risk of vessel injury, but again, our placement medial to the vessels has not led to any significant bleeding. By doing so we are averting a theoretical risk with lateral placement of possibly constricting blood flow to the uterus during pregnancy.

Another technique for suturing that has been described uses a fascial closing device, which, after the needles are removed, passes between the vessels and cervix anteriorly and grasps each end of the suture posteriorly before pulling it through the cervix. My concern with this approach is that entry into the cervix with this device’s sharp needles could cause erosion of the tape into the cervical canal. Piercing of a vessel could also cause bleeding.

Laparoscopic abdominal cerclage can also be placed with robotic assistance, but I don’t believe that the robot offers any benefit for this relatively short, uncomplicated procedure.

A note on patient care

We recommend that patients not become pregnant for 2 months after the laparoscopic abdominal cerclage is placed, and that they receive obstetrical care as high-risk patients. The cerclage can be removed at the time of cesarean delivery if the patient has completed childbearing. Otherwise, if the cerclage appears normal, it can be left in place for future pregnancies.

In the event of a miscarriage, a dilatation and evacuation procedure can be performed with an abdominal cerclage in place, up to 18 weeks of pregnancy. Beyond this point, the patient likely will need to have the cerclage removed laparoscopically to allow vaginal passing of the fetus.

References

1. Shennan A et al. Am J Obstet Gynecol. 2020;222(3):261.E1-261.E9.

2. Clark NV & Einarsson JI. Fertil Steril. 2020;113:717-22.

3. Benson RC & Durfee RB. Obstet Gynecol. 1965;25:145-55.

4. Lesser KB et al. Obstet Gynecol. 1998;91:855-6.

5. Moawad GN et al. J Minim Invasive Gynecol. 2018;25:277-86.
 

Cervical insufficiency is an important cause of preterm birth and complicates up to 1% of pregnancies. It is typically diagnosed as painless cervical dilation without contractions, often in the second trimester at around 16-18 weeks, but the clinical presentation can be variable. In some cases, a rescue cerclage can be placed to prevent second trimester loss or preterm birth.

Dr. Jon I. Einarsson

A recent landmark randomized controlled trial of abdominal vs. vaginal cerclage – the MAVRIC trial (Multicentre Abdominal vs. Vaginal Randomized Intervention of Cerclage)1 published in 2020 – has offered significant validation for the belief that an abdominal approach is the preferred approach for patients with cervical insufficiency and a prior failed vaginal cerclage.

Obstetricians traditionally have had a high threshold for placement of an abdominal cerclage given the need for cesarean delivery and the morbidity of an open procedure. Laparoscopic abdominal cerclage has lowered this threshold and is increasingly the preferred method for cerclage placement. Reported complication rates are generally lower than for open abdominal cerclage, and neonatal survival rates are similar or improved.

In our experience, the move toward laparoscopic abdominal cerclage is largely a patient-driven shift. Since 2007, at Brigham and Women’s Hospital in Boston, we have performed over 150 laparoscopic abdominal cerclage placements. The majority of patients had at least one prior second-trimester loss (many of them had multiple losses), with many having also failed a transvaginal cerclage.

In an analysis of 137 of these cases published recently in Fertility and Sterility, the neonatal survival rate was 93.8% in the 80 pregnancies that followed and extended beyond the first trimester, and the mean gestational age at delivery was 36.9 weeks.2 (First trimester losses are typically excluded from the denominator because they are unlikely to be the result of cervical insufficiency.)

History and outcomes data

The vaginal cerclage has long been a mainstay of therapy because it is a simple procedure. The McDonald technique, described in the 1950s, uses a simple purse string suture at the cervico-vaginal juncture, and the Shirodkar approach, also described in the 1950s, involves placing the cerclage higher on the cervix, as close to the internal os as possible. The Shirodkar technique is more complex, requiring more dissection, and is used less often than the McDonald approach.

The abdominal cerclage, first reported in 1965,3 is placed higher on the cervix, right near the juncture of the lower uterine segment and the cervix, and has generally been thought to provide optimal integrity. It is this point of placement – right at the juncture where membranes begin protruding into the cervix as it shortens and softens – that offers the strongest defense against cervical insufficiency.

The laparoscopic abdominal approach has been gaining popularity since it was first reported in 1998.4 Its traditional indication has been after a prior failed vaginal cerclage or when the cervix is too short to place a vaginal cerclage – as a result of a congenital anomaly or cervical conization, for instance.

Some of my patients have had one pregnancy loss in which cervical insufficiency was suspected and have sought laparoscopic abdominal cerclage without attempting a vaginal cerclage. Data to support this scenario are unavailable, but given the psychological trauma of pregnancy loss and the minimally invasive and low-risk nature of laparoscopic abdominal cerclage, I have been inclined to agree to preventive laparoscopic abdominal procedures without a trial of a vaginal cerclage. I believe this is a reasonable option.

The recently published MAVRIC trial included only abdominal cerclages performed using an open approach, but it provides good data for the scenario in which a vaginal cerclage has failed.

The rates of preterm birth at less than 32 weeks were significantly lower with abdominal cerclage than with low vaginal cerclage (McDonald technique) or high vaginal cerclage (Shirodkar technique) (8% vs. 33%, and 8% vs. 38%). No neonatal deaths occurred.

The analysis covered 111 women who conceived and had known pregnancy outcomes, out of 139 who were recruited and randomized. Cerclage placement occurred either between 10 and 16 weeks of gestation for vaginal cerclages and at 14 weeks for abdominal cerclages or before conception for those assigned to receive an abdominal or high vaginal cerclage.

Reviews of the literature done by our group1 and others have found equivalent outcomes between abdominal cerclages placed through laparotomy and through laparoscopy. The largest systematic review analyzed 31 studies involving 1,844 patients and found that neonatal survival rates were significantly greater in the laparoscopic group (97% vs. 90%), as were rates of deliveries after 34 weeks of gestation (83% vs. 76%).5

The better outcomes in the laparoscopic group may at least partly reflect improved laparoscopic surgeon techniques and improvements in neonatal care over time. At the minimum, we can conclude that neonatal outcomes are at least equivalent when an abdominal cerclage is placed through laparotomy or with a minimally invasive approach.

 

 

Our technique

Laparoscopic cerclages are much more easily placed – and with less risk of surgical complications or blood loss – in patients who are not pregnant. Postconception cerclage placement also carries a unique, small risk of fetal loss (estimated to occur in 1.2% of laparoscopic cases and 3% of open cases). 1 We therefore prefer to perform the procedure before pregnancy, though we do place abdominal cerclages in early pregnancy as well. (Approximately 10% of the 137 patients in our analysis were pregnant at the time of cerclage placement. 1 )

The procedure, described here for the nonpregnant patient, typically requires 3-4 ports. My preference is to use a 10-mm scope at the umbilicus, two 5-mm ipsilateral ports, and an additional 5-mm port for my assistant. We generally use a uterine manipulator to help with dissection and facilitate the correct angulation of the suture needle.

Dr. Jon I. Einarsson
Fig 1. Dissection of the vesicouterine peritoneum. The uterine arteries are indicated by white arrows.


We start by opening the vesicouterine peritoneum to dissect the uterine arteries anteriorly and to move the bladder slightly caudad. It is not a significant dissection.

For suturing, we use 5-mm Mersilene polyester tape with blunt-tip needles – the same tape that is commonly used for vaginal cerclages. The needles (which probably are unnecessarily long for laparoscopic cerclages) are straightened out prior to insertion with robust needle holders.

Dr. Jon I. Einarsson
Fig 2. Initial placement of the first needle on the right. The uterine artery is indicated with a red arrow, the ureter with a white arrow, and the site of the insertion of the left needle is shown with a blue dot.


The posterior broad ligament is not opened prior to insertion of the needle, as opening the broad ligament risks possible vessel injury and adds complexity.

Dr. Jon I. Einarsson
Fig 3. Twisting the uterus with the uterine manipulator enables the surgeon to better visualize the correct path of the needle placement.

Direct insertion of the needle simplifies the procedure and has not led to any complications thus far.

We prefer to insert the suture posteriorly at the level of the internal os just above the insertion of the uterosacral ligaments. It is helpful to view the uterus and cervix as an hourglass, with the level of the internal os is at the narrowest point of the hourglass.

The suture is passed carefully between the uterine vessels and the cervical stroma. The uterine artery should be lateral to placement of the needle, and the uterosacral ligament should be below. The surgeon should see a pulsation of the uterine artery. The use of blunt needles is advantageous because, especially when newer to the procedure, the surgeon can place the needle in slightly more medial than may be deemed necessary so as to avert the uterine vessels, then adjust placement slightly more laterally if resistance is met.

Suture placement should follow a fairly low-impact path. Encountering too much resistance with the needle signals passage into the cervix and necessitates redirection of the needle with a slightly more lateral placement. Twisting the uterus with the uterine manipulator can be helpful throughout this process.

Once the needles are passed through, they are cut off the Mersilene tape and removed. For suturing, it’s important that the first and second knots are tied down snuggly and flat.

Dr. Jon I. Einarsson
Fig 4. The first knot has been tied down.

I usually ask my assistant to hold down the first knot so that it doesn’t unravel while I tie the second knot. I usually tie 6 square knots with the tape.

Dr. Jon I. Einarsson
Fig 5. All knots have been tied down.

The edges of the tape are then trimmed, and with a 2.0 silk suture, the ends are secured to the lower uterine segment to prevent a theoretical risk of erosion into the bladder.

Dr. Jon I. Einarsson
Fig 6. The ends of the mersilene tape have been tied down with silk suture.

We then close the overlying vesicouterine peritoneum with 2-0 Monocryl suture, tying it intracorporally. Closing the peritoneum posteriorly is generally not necessary.

Dr. Jon I. Einarsson
Fig 7. The vesicouterine peritoneum has been closed


We have not had significant bleeding or severe complications in any of our cases. And while the literature comparing preconception and postconception abdominal cerclage is limited, the risks appear very low especially before pregnancy. Some oozing from the uterine vein can sometimes occur; if this does not resolve once it is tied down, placement of a simple figure of eight suture such as a Monocryl or Vicryl at the posterior insertion of the tape may be necessary to stop the bleeding.

Some surgeons place the abdominal cerclage lateral to the uterine artery, presumably to lessen any risk of vessel injury, but again, our placement medial to the vessels has not led to any significant bleeding. By doing so we are averting a theoretical risk with lateral placement of possibly constricting blood flow to the uterus during pregnancy.

Another technique for suturing that has been described uses a fascial closing device, which, after the needles are removed, passes between the vessels and cervix anteriorly and grasps each end of the suture posteriorly before pulling it through the cervix. My concern with this approach is that entry into the cervix with this device’s sharp needles could cause erosion of the tape into the cervical canal. Piercing of a vessel could also cause bleeding.

Laparoscopic abdominal cerclage can also be placed with robotic assistance, but I don’t believe that the robot offers any benefit for this relatively short, uncomplicated procedure.

A note on patient care

We recommend that patients not become pregnant for 2 months after the laparoscopic abdominal cerclage is placed, and that they receive obstetrical care as high-risk patients. The cerclage can be removed at the time of cesarean delivery if the patient has completed childbearing. Otherwise, if the cerclage appears normal, it can be left in place for future pregnancies.

In the event of a miscarriage, a dilatation and evacuation procedure can be performed with an abdominal cerclage in place, up to 18 weeks of pregnancy. Beyond this point, the patient likely will need to have the cerclage removed laparoscopically to allow vaginal passing of the fetus.

References

1. Shennan A et al. Am J Obstet Gynecol. 2020;222(3):261.E1-261.E9.

2. Clark NV & Einarsson JI. Fertil Steril. 2020;113:717-22.

3. Benson RC & Durfee RB. Obstet Gynecol. 1965;25:145-55.

4. Lesser KB et al. Obstet Gynecol. 1998;91:855-6.

5. Moawad GN et al. J Minim Invasive Gynecol. 2018;25:277-86.
 

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

When it comes to young women, regular check-ins support ongoing PrEP use

Article Type
Changed
Tue, 07/27/2021 - 14:16

 

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

 

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Closing the racial gap in minimally invasive gyn hysterectomy and myomectomy

Article Type
Changed
Mon, 08/02/2021 - 14:16

The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.4 Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.5

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.5 According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.6 Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.7 Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.8

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.9 Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.10 A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.11 Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.14 The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.18

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.19 These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,20 calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.21 Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.22

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.23 These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.24

Continue to: How to ensure that BIPOC women get the best management...

 

 

How to ensure that BIPOC women get the best management

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.25 Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.26 Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.8 Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.27 Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.28 It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.29 As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,30 this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.31 Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.32 Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.5 Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;33 therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.34 Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,35 found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).36

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.35 Much work remains to be done for our health care systems to provide equitable care.

References
  1. Ojanuga D. The medical ethics of the ‘father of gynaecology,’ Dr J Marion Sims. J Med Ethics. 1993;19:28-31. doi: 10.1136/jme.19.1.28.
  2. Borrero S, Zite N, Creinin MD. Federally funded sterilization: time to rethink policy? Am J Public Health. 2012;102:1822-1825.
  3. Eaglehouse YL, Georg MW, Shriver CD, et al. Racial differences in time to breast cancer surgery and overall survival in the US Military Health System. JAMA Surg. 2019;154:e185113. doi: 10.1001/jamasurg.2018.5113.
  4. Soliman AM, Yang H, Du EX, et al. The direct and indirect costs of uterine fibroid tumors: a systematic review of the literature between 2000 and 2013. Am J Obstet Gynecol. 2015;213:141-160.
  5. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
  6. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973. doi: 10.1016/s0029-7844(97)00534-6.
  7. Styer AK, Rueda BR. The epidemiology and genetics of uterine leiomyoma. Best Pract Res Clin Obstet Gynaecol. 2016;34:3-12. doi: 10.1016/j.bpobgyn.2015.11.018.
  8. Al-Hendy A, Myers ER, Stewart E. Uterine fibroids: burden and unmet medical need. Semin Reprod Med. 2017;35:473-480. doi: 10.1055/s-0037-1607264.
  9. American College of Obstetricians and Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. 2008;112(2 pt 1):387-400.
  10. Corona LE, Swenson CW, Sheetz KH, et al. Use of other treatments before hysterectomy for benign conditions in a statewide hospital collaborative. Am J Obstet Gynecol. 2015;212:304.e1-e7. doi: 10.1016/j.ajog.2014.11.031.
  11. Nguyen NT, Merchant M, Ritterman Weintraub ML, et al. Alternative treatment utilization before hysterectomy for benign gynecologic conditions at a large integrated health system. J Minim Invasive Gynecol. 2019;26:847-855. doi: 10.1016/j.jmig.2018.08.013.
  12. Laughlin-Tommaso SK, Jacoby VL, Myers ER. Disparities in fibroid incidence, prognosis, and management. Obstet Gynecol Clin North Am. 2017;44:81-94. doi: 10.1016/j.ogc.2016.11.007.
  13. Borah BJ, Laughlin-Tommaso SK, Myers ER, et al. Association between patient characteristics and treatment procedure among patients with uterine leiomyomas. Obstet Gynecol. 2016;127:67-77.
  14. Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient hysterectomy surveillance in the United States, 2000-2004. Am J Obstet Gynecol. 2008;198:34.e1-e7. doi:10.1016/j.ajog.2007.05.039.
  15. Bardens D, Solomayer E, Baum S, et al. The impact of the body mass index (BMI) on laparoscopic hysterectomy for benign disease. Arch Gynecol Obstet. 2014;289:803-807. doi: 10.1007/s00404-013-3050-2.
  16. Seracchioli R, Venturoli S, Vianello F, et al. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002;9:333-338. doi: 10.1016/s1074-3804(05)60413.
  17. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915. doi: 10.1097/AOG.0b013e3181f395d9.
  18. Jin C, Hu Y, Chen XC, et al. Laparoscopic versus open myomectomy—a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009;145:14-21. doi: 10.1016/j.ejogrb.2009.03.009.
  19. Wechter ME, Stewart EA, Myers ER, et al. Leiomyoma-related hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol. 2011;205:492.e1-e5. doi: 10.1016/j.ajog.2011.07.008.
  20. Bower JK, Schreiner PJ, Sternfeld B, et al. Black-White differences in hysterectomy prevalence: the CARDIA study. Am J Public Health. 2009;99:300-307. doi: 10.2105/AJPH.2008.133702.
  21. Ranjit A, Sharma M, Romano A, et al. Does universal insurance mitigate racial differences in minimally invasive hysterectomy? J Minim Invasive Gynecol. 2017;24. doi:10.1016/j.jmig.2017.03.016.
  22. Pollack LM, Olsen MA, Gehlert SJ, et al. Racial/ethnic disparities/differences in hysterectomy route in women likely eligible for minimally invasive surgery. J Minim Invasive Gynecol. 2020;27:1167-1177.e2. doi:10.1016/j.jmig.2019.09.003.
  23. Stentz NC, Cooney LG, Sammel MD, et al. Association of patient race with surgical practice and perioperative morbidity after myomectomy. Obstet Gynecol. 2018;132:291-297. doi: 10.1097/AOG.0000000000002738.
  24. Roth TM, Gustilo-Ashby T, Barber MD, et al. Effects of race and clinical factors on short-term outcomes of abdominal myomectomy. Obstet Gynecol. 2003;101(5 pt 1):881-884. doi: 10.1016/s0029-7844(03)00015-2.
  25. Bratka S, Diamond JS, Al-Hendy A, et al. The role of vitamin D in uterine fibroid biology. Fertil Steril. 2015;104:698-706. doi: 10.1016/j.fertnstert.2015.05.031.
  26. Ciebiera M, Łukaszuk K, Męczekalski B, et al. Alternative oral agents in prophylaxis and therapy of uterine fibroids—an up-to-date review. Int J Mol Sci. 2017;18:2586. doi:10.3390/ijms18122586.
  27. Hayden EC. Racial bias haunts NIH funding. Nature. 2015;527:145.
  28. Lett LA, Orji WU, Sebro R. Declining racial and ethnic representation in clinical academic medicine: a longitudinal study of 16 US medical specialties. PLoS One. 2018;13:e0207274. doi: 10.1371/journal.pone.0207274.
  29. Sánchez JP, Poll-Hunter N, Stern N, et al. Balancing two cultures: American Indian/Alaska Native medical students’ perceptions of academic medicine careers. J Community Health. 2016;41:871-880.
  30. Rayburn WF, Xierali IM, Castillo-Page L, et al. Racial and ethnic differences between obstetrician-gynecologists and other adult medical specialists. Obstet Gynecol. 2016;127:148-152. doi: 10.1097/AOG.0000000000001184.
  31. Esters D, Xierali IM, Nivet MA, et al. The rise of nontenured faculty in obstetrics and gynecology by sex and underrepresented in medicine status. Obstet Gynecol. 2019;134 suppl 1:34S-39S. doi: 10.1097/AOG.0000000000003484.
  32. Ly DP, Seabury SA, Jena AB. Differences in incomes of physicians in the United States by race and sex: observational study. BMJ. 2016;I2923. doi:10.1136/bmj.i2923.
  33. Groff JY, Mullen PD, Byrd T, et al. Decision making, beliefs, and attitudes toward hysterectomy: a focus group study with medically underserved women in Texas. J Womens Health Gend Based Med. 2000;9 suppl 2:S39-50. doi: 10.1089/152460900318759.
  34. Andryjowicz E, Wray T. Regional expansion of minimally invasive surgery for hysterectomy: implementation and methodology in a large multispecialty group. Perm J. 2011;15:42-46.
  35. Zaritsky E, Ojo A, Tucker LY, et al. Racial disparities in route of hysterectomy for benign indications within an integrated health care system. JAMA Netw Open. 2019;2:e1917004. doi: 10.1001/jamanetworkopen.2019.17004.
  36. Abel MK, Kho KA, Walter A, et al. Measuring quality in minimally invasive gynecologic surgery: what, how, and why? J Minim Invasive Gynecol. 2019;26:321-326. doi: 10.1016/j.jmig.2018.11.013.
Author and Disclosure Information

Dr. Zaritsky is Minimally Invasive Gynecologic Surgeon and Assistant Residency Program Director, Kaiser Permanente Northern California, Oakland Medical Center. 

 

Dr. Ojo is a Chief Resident in Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

Dr. Ritterman Weintraub is Senior Research Project Manager Graduate Medical Education, Kaiser Permanente Northern California. 

 

Dr. Raine-Bennett is Senior Staff Physician and Senior Research Scientist in Division of Research, Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

The authors report no financial relationships relevant to this article. 

 

 

Issue
OBG Management - 33(7)
Publications
Topics
Sections
Author and Disclosure Information

Dr. Zaritsky is Minimally Invasive Gynecologic Surgeon and Assistant Residency Program Director, Kaiser Permanente Northern California, Oakland Medical Center. 

 

Dr. Ojo is a Chief Resident in Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

Dr. Ritterman Weintraub is Senior Research Project Manager Graduate Medical Education, Kaiser Permanente Northern California. 

 

Dr. Raine-Bennett is Senior Staff Physician and Senior Research Scientist in Division of Research, Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

The authors report no financial relationships relevant to this article. 

 

 

Author and Disclosure Information

Dr. Zaritsky is Minimally Invasive Gynecologic Surgeon and Assistant Residency Program Director, Kaiser Permanente Northern California, Oakland Medical Center. 

 

Dr. Ojo is a Chief Resident in Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

Dr. Ritterman Weintraub is Senior Research Project Manager Graduate Medical Education, Kaiser Permanente Northern California. 

 

Dr. Raine-Bennett is Senior Staff Physician and Senior Research Scientist in Division of Research, Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

The authors report no financial relationships relevant to this article. 

 

 

The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.4 Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.5

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.5 According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.6 Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.7 Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.8

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.9 Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.10 A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.11 Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.14 The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.18

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.19 These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,20 calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.21 Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.22

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.23 These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.24

Continue to: How to ensure that BIPOC women get the best management...

 

 

How to ensure that BIPOC women get the best management

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.25 Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.26 Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.8 Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.27 Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.28 It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.29 As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,30 this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.31 Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.32 Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.5 Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;33 therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.34 Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,35 found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).36

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.35 Much work remains to be done for our health care systems to provide equitable care.

The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.4 Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.5

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.5 According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.6 Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.7 Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.8

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.9 Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.10 A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.11 Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.14 The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.18

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.19 These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,20 calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.21 Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.22

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.23 These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.24

Continue to: How to ensure that BIPOC women get the best management...

 

 

How to ensure that BIPOC women get the best management

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.25 Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.26 Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.8 Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.27 Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.28 It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.29 As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,30 this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.31 Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.32 Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.5 Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;33 therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.34 Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,35 found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).36

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.35 Much work remains to be done for our health care systems to provide equitable care.

References
  1. Ojanuga D. The medical ethics of the ‘father of gynaecology,’ Dr J Marion Sims. J Med Ethics. 1993;19:28-31. doi: 10.1136/jme.19.1.28.
  2. Borrero S, Zite N, Creinin MD. Federally funded sterilization: time to rethink policy? Am J Public Health. 2012;102:1822-1825.
  3. Eaglehouse YL, Georg MW, Shriver CD, et al. Racial differences in time to breast cancer surgery and overall survival in the US Military Health System. JAMA Surg. 2019;154:e185113. doi: 10.1001/jamasurg.2018.5113.
  4. Soliman AM, Yang H, Du EX, et al. The direct and indirect costs of uterine fibroid tumors: a systematic review of the literature between 2000 and 2013. Am J Obstet Gynecol. 2015;213:141-160.
  5. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
  6. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973. doi: 10.1016/s0029-7844(97)00534-6.
  7. Styer AK, Rueda BR. The epidemiology and genetics of uterine leiomyoma. Best Pract Res Clin Obstet Gynaecol. 2016;34:3-12. doi: 10.1016/j.bpobgyn.2015.11.018.
  8. Al-Hendy A, Myers ER, Stewart E. Uterine fibroids: burden and unmet medical need. Semin Reprod Med. 2017;35:473-480. doi: 10.1055/s-0037-1607264.
  9. American College of Obstetricians and Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. 2008;112(2 pt 1):387-400.
  10. Corona LE, Swenson CW, Sheetz KH, et al. Use of other treatments before hysterectomy for benign conditions in a statewide hospital collaborative. Am J Obstet Gynecol. 2015;212:304.e1-e7. doi: 10.1016/j.ajog.2014.11.031.
  11. Nguyen NT, Merchant M, Ritterman Weintraub ML, et al. Alternative treatment utilization before hysterectomy for benign gynecologic conditions at a large integrated health system. J Minim Invasive Gynecol. 2019;26:847-855. doi: 10.1016/j.jmig.2018.08.013.
  12. Laughlin-Tommaso SK, Jacoby VL, Myers ER. Disparities in fibroid incidence, prognosis, and management. Obstet Gynecol Clin North Am. 2017;44:81-94. doi: 10.1016/j.ogc.2016.11.007.
  13. Borah BJ, Laughlin-Tommaso SK, Myers ER, et al. Association between patient characteristics and treatment procedure among patients with uterine leiomyomas. Obstet Gynecol. 2016;127:67-77.
  14. Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient hysterectomy surveillance in the United States, 2000-2004. Am J Obstet Gynecol. 2008;198:34.e1-e7. doi:10.1016/j.ajog.2007.05.039.
  15. Bardens D, Solomayer E, Baum S, et al. The impact of the body mass index (BMI) on laparoscopic hysterectomy for benign disease. Arch Gynecol Obstet. 2014;289:803-807. doi: 10.1007/s00404-013-3050-2.
  16. Seracchioli R, Venturoli S, Vianello F, et al. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002;9:333-338. doi: 10.1016/s1074-3804(05)60413.
  17. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915. doi: 10.1097/AOG.0b013e3181f395d9.
  18. Jin C, Hu Y, Chen XC, et al. Laparoscopic versus open myomectomy—a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009;145:14-21. doi: 10.1016/j.ejogrb.2009.03.009.
  19. Wechter ME, Stewart EA, Myers ER, et al. Leiomyoma-related hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol. 2011;205:492.e1-e5. doi: 10.1016/j.ajog.2011.07.008.
  20. Bower JK, Schreiner PJ, Sternfeld B, et al. Black-White differences in hysterectomy prevalence: the CARDIA study. Am J Public Health. 2009;99:300-307. doi: 10.2105/AJPH.2008.133702.
  21. Ranjit A, Sharma M, Romano A, et al. Does universal insurance mitigate racial differences in minimally invasive hysterectomy? J Minim Invasive Gynecol. 2017;24. doi:10.1016/j.jmig.2017.03.016.
  22. Pollack LM, Olsen MA, Gehlert SJ, et al. Racial/ethnic disparities/differences in hysterectomy route in women likely eligible for minimally invasive surgery. J Minim Invasive Gynecol. 2020;27:1167-1177.e2. doi:10.1016/j.jmig.2019.09.003.
  23. Stentz NC, Cooney LG, Sammel MD, et al. Association of patient race with surgical practice and perioperative morbidity after myomectomy. Obstet Gynecol. 2018;132:291-297. doi: 10.1097/AOG.0000000000002738.
  24. Roth TM, Gustilo-Ashby T, Barber MD, et al. Effects of race and clinical factors on short-term outcomes of abdominal myomectomy. Obstet Gynecol. 2003;101(5 pt 1):881-884. doi: 10.1016/s0029-7844(03)00015-2.
  25. Bratka S, Diamond JS, Al-Hendy A, et al. The role of vitamin D in uterine fibroid biology. Fertil Steril. 2015;104:698-706. doi: 10.1016/j.fertnstert.2015.05.031.
  26. Ciebiera M, Łukaszuk K, Męczekalski B, et al. Alternative oral agents in prophylaxis and therapy of uterine fibroids—an up-to-date review. Int J Mol Sci. 2017;18:2586. doi:10.3390/ijms18122586.
  27. Hayden EC. Racial bias haunts NIH funding. Nature. 2015;527:145.
  28. Lett LA, Orji WU, Sebro R. Declining racial and ethnic representation in clinical academic medicine: a longitudinal study of 16 US medical specialties. PLoS One. 2018;13:e0207274. doi: 10.1371/journal.pone.0207274.
  29. Sánchez JP, Poll-Hunter N, Stern N, et al. Balancing two cultures: American Indian/Alaska Native medical students’ perceptions of academic medicine careers. J Community Health. 2016;41:871-880.
  30. Rayburn WF, Xierali IM, Castillo-Page L, et al. Racial and ethnic differences between obstetrician-gynecologists and other adult medical specialists. Obstet Gynecol. 2016;127:148-152. doi: 10.1097/AOG.0000000000001184.
  31. Esters D, Xierali IM, Nivet MA, et al. The rise of nontenured faculty in obstetrics and gynecology by sex and underrepresented in medicine status. Obstet Gynecol. 2019;134 suppl 1:34S-39S. doi: 10.1097/AOG.0000000000003484.
  32. Ly DP, Seabury SA, Jena AB. Differences in incomes of physicians in the United States by race and sex: observational study. BMJ. 2016;I2923. doi:10.1136/bmj.i2923.
  33. Groff JY, Mullen PD, Byrd T, et al. Decision making, beliefs, and attitudes toward hysterectomy: a focus group study with medically underserved women in Texas. J Womens Health Gend Based Med. 2000;9 suppl 2:S39-50. doi: 10.1089/152460900318759.
  34. Andryjowicz E, Wray T. Regional expansion of minimally invasive surgery for hysterectomy: implementation and methodology in a large multispecialty group. Perm J. 2011;15:42-46.
  35. Zaritsky E, Ojo A, Tucker LY, et al. Racial disparities in route of hysterectomy for benign indications within an integrated health care system. JAMA Netw Open. 2019;2:e1917004. doi: 10.1001/jamanetworkopen.2019.17004.
  36. Abel MK, Kho KA, Walter A, et al. Measuring quality in minimally invasive gynecologic surgery: what, how, and why? J Minim Invasive Gynecol. 2019;26:321-326. doi: 10.1016/j.jmig.2018.11.013.
References
  1. Ojanuga D. The medical ethics of the ‘father of gynaecology,’ Dr J Marion Sims. J Med Ethics. 1993;19:28-31. doi: 10.1136/jme.19.1.28.
  2. Borrero S, Zite N, Creinin MD. Federally funded sterilization: time to rethink policy? Am J Public Health. 2012;102:1822-1825.
  3. Eaglehouse YL, Georg MW, Shriver CD, et al. Racial differences in time to breast cancer surgery and overall survival in the US Military Health System. JAMA Surg. 2019;154:e185113. doi: 10.1001/jamasurg.2018.5113.
  4. Soliman AM, Yang H, Du EX, et al. The direct and indirect costs of uterine fibroid tumors: a systematic review of the literature between 2000 and 2013. Am J Obstet Gynecol. 2015;213:141-160.
  5. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
  6. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973. doi: 10.1016/s0029-7844(97)00534-6.
  7. Styer AK, Rueda BR. The epidemiology and genetics of uterine leiomyoma. Best Pract Res Clin Obstet Gynaecol. 2016;34:3-12. doi: 10.1016/j.bpobgyn.2015.11.018.
  8. Al-Hendy A, Myers ER, Stewart E. Uterine fibroids: burden and unmet medical need. Semin Reprod Med. 2017;35:473-480. doi: 10.1055/s-0037-1607264.
  9. American College of Obstetricians and Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. 2008;112(2 pt 1):387-400.
  10. Corona LE, Swenson CW, Sheetz KH, et al. Use of other treatments before hysterectomy for benign conditions in a statewide hospital collaborative. Am J Obstet Gynecol. 2015;212:304.e1-e7. doi: 10.1016/j.ajog.2014.11.031.
  11. Nguyen NT, Merchant M, Ritterman Weintraub ML, et al. Alternative treatment utilization before hysterectomy for benign gynecologic conditions at a large integrated health system. J Minim Invasive Gynecol. 2019;26:847-855. doi: 10.1016/j.jmig.2018.08.013.
  12. Laughlin-Tommaso SK, Jacoby VL, Myers ER. Disparities in fibroid incidence, prognosis, and management. Obstet Gynecol Clin North Am. 2017;44:81-94. doi: 10.1016/j.ogc.2016.11.007.
  13. Borah BJ, Laughlin-Tommaso SK, Myers ER, et al. Association between patient characteristics and treatment procedure among patients with uterine leiomyomas. Obstet Gynecol. 2016;127:67-77.
  14. Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient hysterectomy surveillance in the United States, 2000-2004. Am J Obstet Gynecol. 2008;198:34.e1-e7. doi:10.1016/j.ajog.2007.05.039.
  15. Bardens D, Solomayer E, Baum S, et al. The impact of the body mass index (BMI) on laparoscopic hysterectomy for benign disease. Arch Gynecol Obstet. 2014;289:803-807. doi: 10.1007/s00404-013-3050-2.
  16. Seracchioli R, Venturoli S, Vianello F, et al. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002;9:333-338. doi: 10.1016/s1074-3804(05)60413.
  17. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915. doi: 10.1097/AOG.0b013e3181f395d9.
  18. Jin C, Hu Y, Chen XC, et al. Laparoscopic versus open myomectomy—a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009;145:14-21. doi: 10.1016/j.ejogrb.2009.03.009.
  19. Wechter ME, Stewart EA, Myers ER, et al. Leiomyoma-related hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol. 2011;205:492.e1-e5. doi: 10.1016/j.ajog.2011.07.008.
  20. Bower JK, Schreiner PJ, Sternfeld B, et al. Black-White differences in hysterectomy prevalence: the CARDIA study. Am J Public Health. 2009;99:300-307. doi: 10.2105/AJPH.2008.133702.
  21. Ranjit A, Sharma M, Romano A, et al. Does universal insurance mitigate racial differences in minimally invasive hysterectomy? J Minim Invasive Gynecol. 2017;24. doi:10.1016/j.jmig.2017.03.016.
  22. Pollack LM, Olsen MA, Gehlert SJ, et al. Racial/ethnic disparities/differences in hysterectomy route in women likely eligible for minimally invasive surgery. J Minim Invasive Gynecol. 2020;27:1167-1177.e2. doi:10.1016/j.jmig.2019.09.003.
  23. Stentz NC, Cooney LG, Sammel MD, et al. Association of patient race with surgical practice and perioperative morbidity after myomectomy. Obstet Gynecol. 2018;132:291-297. doi: 10.1097/AOG.0000000000002738.
  24. Roth TM, Gustilo-Ashby T, Barber MD, et al. Effects of race and clinical factors on short-term outcomes of abdominal myomectomy. Obstet Gynecol. 2003;101(5 pt 1):881-884. doi: 10.1016/s0029-7844(03)00015-2.
  25. Bratka S, Diamond JS, Al-Hendy A, et al. The role of vitamin D in uterine fibroid biology. Fertil Steril. 2015;104:698-706. doi: 10.1016/j.fertnstert.2015.05.031.
  26. Ciebiera M, Łukaszuk K, Męczekalski B, et al. Alternative oral agents in prophylaxis and therapy of uterine fibroids—an up-to-date review. Int J Mol Sci. 2017;18:2586. doi:10.3390/ijms18122586.
  27. Hayden EC. Racial bias haunts NIH funding. Nature. 2015;527:145.
  28. Lett LA, Orji WU, Sebro R. Declining racial and ethnic representation in clinical academic medicine: a longitudinal study of 16 US medical specialties. PLoS One. 2018;13:e0207274. doi: 10.1371/journal.pone.0207274.
  29. Sánchez JP, Poll-Hunter N, Stern N, et al. Balancing two cultures: American Indian/Alaska Native medical students’ perceptions of academic medicine careers. J Community Health. 2016;41:871-880.
  30. Rayburn WF, Xierali IM, Castillo-Page L, et al. Racial and ethnic differences between obstetrician-gynecologists and other adult medical specialists. Obstet Gynecol. 2016;127:148-152. doi: 10.1097/AOG.0000000000001184.
  31. Esters D, Xierali IM, Nivet MA, et al. The rise of nontenured faculty in obstetrics and gynecology by sex and underrepresented in medicine status. Obstet Gynecol. 2019;134 suppl 1:34S-39S. doi: 10.1097/AOG.0000000000003484.
  32. Ly DP, Seabury SA, Jena AB. Differences in incomes of physicians in the United States by race and sex: observational study. BMJ. 2016;I2923. doi:10.1136/bmj.i2923.
  33. Groff JY, Mullen PD, Byrd T, et al. Decision making, beliefs, and attitudes toward hysterectomy: a focus group study with medically underserved women in Texas. J Womens Health Gend Based Med. 2000;9 suppl 2:S39-50. doi: 10.1089/152460900318759.
  34. Andryjowicz E, Wray T. Regional expansion of minimally invasive surgery for hysterectomy: implementation and methodology in a large multispecialty group. Perm J. 2011;15:42-46.
  35. Zaritsky E, Ojo A, Tucker LY, et al. Racial disparities in route of hysterectomy for benign indications within an integrated health care system. JAMA Netw Open. 2019;2:e1917004. doi: 10.1001/jamanetworkopen.2019.17004.
  36. Abel MK, Kho KA, Walter A, et al. Measuring quality in minimally invasive gynecologic surgery: what, how, and why? J Minim Invasive Gynecol. 2019;26:321-326. doi: 10.1016/j.jmig.2018.11.013.
Issue
OBG Management - 33(7)
Issue
OBG Management - 33(7)
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Placental allograft, cytology processor, cell-free RNA testing, and male infertility

Article Type
Changed
Wed, 07/14/2021 - 14:08

 

Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

Article PDF
Issue
OBG Management - 33(7)
Publications
Topics
Page Number
48
Sections
Article PDF
Article PDF

 

Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

 

Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

Issue
OBG Management - 33(7)
Issue
OBG Management - 33(7)
Page Number
48
Page Number
48
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

Hepatitis in pregnancy: Sorting through the alphabet

Article Type
Changed
Mon, 07/12/2021 - 14:50

 

 

CASE Pregnant woman with positive hepatitis B surface antigen

A 27-year-old primigravida at 9 weeks 3 days of gestation tests positive for the hepatitis B surface antigen at her first prenatal appointment. She is completely asymptomatic.

  • What additional tests are indicated?

 

  • Does she pose a risk to her sexual partner, and is her newborn at risk for acquiring hepatitis B?

 

  • Can anything be done to protect her partner and newborn from infection?

Meet our perpetrator

Hepatitis is one of the more common viral infections that may occur during pregnancy. Two forms of hepatitis, notably hepatitis A and E, pose a primary threat to the mother. Three forms (B, C, and D) present dangers for the mother, fetus, and newborn. This article will review the epidemiology, clinical manifestations, perinatal implications, and management of the various forms of viral hepatitis. (TABLE 1).

Hepatitis A

Hepatitis A is caused by an RNA virus that is transmitted by fecal-oral contact. The disease is most prevalent in areas with poor sanitation and close living conditions. The incubation period ranges from 15 to 50 days. Most children who acquire this disease are asymptomatic. By contrast, most infected adults are acutely symptomatic. Clinical manifestations typically include low-grade fever, malaise, anorexia, right upper quadrant pain and tenderness, jaundice, and claycolored stools.1,2

The diagnosis of acute hepatitis A infection is best confirmed by detection of immunoglobulin M (IgM)-specific antibodies. The serum transaminase concentrations and the serum bilirubin concentrations usually are significantly elevated. The international normalized ratio, prothrombin time, and partial thromboplastin time also may be elevated.1,2

The treatment for acute hepatitis A largely is supportive care: maintaining hydration, optimizing nutrition, and correcting coagulation abnormalities. The appropriate measures for prevention of hepatitis A are adoption of sound sanitation practices, particularly water purification; minimizing overcrowded living conditions; and administering the hepatitis A vaccine for both pre and postexposure prophylaxis.3,4 The hepatitis A vaccine is preferred over administration of immune globulin because it provides lifelong immunity.

The hepatitis A vaccine is produced in 2 monovalent formulations: Havrix (GlaxoSmithKline) and Vaqta (Merck & Co, Inc). The vaccine should be administered intramuscularly in 2 doses 6 to 12 months apart. The wholesale cost of the vaccine varies from $66 to $119 (according to http://www.goodrx.com). The vaccine also is available in a bivalent form, with recombinant hepatitis B vaccine (Twinrix, GlaxoSmithKline). When used in this form, 3 vaccine administrations are given—at 0, 1, and 6 months apart. The cost of the vaccine is approximately $150 (according to http://www.goodrx.com). TABLE 2 lists the individuals who are appropriate candidates for the hepatitis A vaccine.3,4

Hepatitis B

Hepatitis B is caused by a DNA virus that is transmitted parenterally or perinatally or through sexual contact. Four genotypes have been identified: A, B, C, and D.

Acute hepatitis B affects 1 to 2 of 1,000 pregnancies in the United States. Approximately 6 to 10 patients per 1,000 pregnancies are asymptomatic but chronically infected.4 The natural history of hepatitis B infection is shown in the FIGURE. The diagnosis of acute and chronic hepatitis B is best established by serology and polymerase chain reaction (PCR; TABLE 3).



All pregnant women should be routinely screened for the hepatitis B surface antigen.5,6 If they are seropositive for the surface antigen alone and receive no immunoprophylaxis, they have a 20% to 30% risk of transmitting infection to their neonate. Subsequently, if they also test positive for the hepatitis Be antigen, the risk of perinatal transmission increases to approximately 90%. Fortunately, 2 forms of immunoprophylaxis are highly effective in preventing perinatal transmission. Infants delivered to seropositive mothers should receive hepatitis B immune globulin within 12 hours of birth. Prior to discharge, the infant also should receive the first dose of the hepatitis B vaccine. Subsequent doses should be administered at 1 and 6 months of age. Infants delivered to seronegative mothers require only the vaccine series.1

Although immunoprophylaxis is highly effective, some neonates still acquire infection perinatally. Pan and colleagues7 and Jourdain et al8 demonstrated that administration of tenofovir 200 mg orally each day from 32 weeks’ gestation until delivery provided further protection against perinatal transmission in patients with a high viral load (defined as >1 million copies/mL). In 2016, the Society for Maternal-Fetal Medicine endorsed the use of tenofovir in women with a high viral load.6

Following delivery, women with chronic hepatitis B infection should be referred to a hepatology specialist for consideration of direct antiviral treatment. Multiple drugs are now available that are highly active against this micro-organism. These drugs include several forms of interferon, lamivudine, adefovir, entecavir, telbivudine, and tenofovir.1

Continue to: Hepatitis C...

 

 

Hepatitis C

Hepatitis C is caused by an RNA virus that has 6 genotypes. The most common genotype is HCV1, which affects 79% of patients; approximately 13% of patients have HCV2, and 6% have HCV3.9 Of note, the 3 individuals who discovered this virus—Drs. Harvey Alter, Michael Houghton, and Charles Rice—received the 2020 Nobel Prize in Medicine.10

Hepatitis C is transmitted via sexual contact, parenterally, and perinatally. In many patient populations in the United States, hepatitis C is now more prevalent than hepatitis B. Only about half of all infected persons are aware of their infection. If patients go untreated, approximately 15% to 30% eventually develop cirrhosis. Of these individuals, 1% to 3% develop hepatocellular cancer. Chronic hepatitis C is now the most common indication for liver transplantation in the United States.1,9

In the initial stages of infection, hepatitis C usually is asymptomatic. The best screening test is detection of hepatitis C antibody. Because of the increasing prevalence of this disease, the seriousness of the infection, and the recent availability of remarkably effective treatment, routine screening, rather than screening on the basis of risk factors, for hepatitis C in pregnancy is now indicated.11,12

The best tests for confirmation of infection are detection of antibody by enzyme immunoassay and recombinant immuno-blot assay and detection of viral RNA in serum by PCR. Seroconversion may not occur for up to 16 weeks after infection. Therefore, in at-risk patients who initially test negative, retesting is advisable. Patients with positive test results should have tests to identify the specific genotype, determine the viral load, and assess liver function.1

In patients who have undetectable viral loads and who do not have coexisting HIV infection, the risk of perinatal transmission of hepatitis C is less than 5%. If HIV infection is present, the risk of perinatal transmission approaches 20%.1,13,14

If the patient is coinfected with HIV, a scheduled cesarean delivery should be performed at 38 weeks’ gestation.1 If the viral load is undetectable, vaginal delivery is appropriate. If the viral load is high, however (arbitrarily defined as >2.5 millioncopies/mL), the optimal method of delivery is controversial. Several small, nonrandomized noncontrolled cohort studies support elective cesarean delivery in such patients.14

There is no contraindication to breastfeeding in women with hepatitis C unless they are coinfected with HIV. In such a circumstance, formula feeding should be chosen. After delivery, patients with hepatitis C should be referred to a gastroenterology specialist to receive antiviral treatment. Multiple new single-agent and combination regimens have produced cures in more than 90% of patients. These regimens usually require 8 to 12 weeks of treatment, and they are very expensive. They have not been widely tested in pregnant women.1

Hepatitis D

Hepatitis D, or delta hepatitis, is caused by an RNA virus. This virus is unique because it is incapable of independent replication. It must be present in association with hepatitis B to replicate and cause clinical infection. Therefore, the epidemiology of hepatitis D closely mirrors that of hepatitis B.1,2

Patients with hepatitis D typically present in one of two ways. Some individuals are acutely infected with hepatitis D at the same time that they acquire hepatitis B (coinfection). The natural history of this infection usually is spontaneous resolution without sequelae. Other patients have chronic hepatitis D superimposed on chronic hepatitis B (superinfection). Unfortunately, patients with the latter condition are at a notably increased risk for developing severe persistent liver disease.1,2

The diagnosis of hepatitis D may be confirmed by identifying the delta antigen in serum or in liver tissue obtained by biopsy or by identifying IgM- and IgG-specific antibodies in serum. In conjunction with hepatitis B, the delta virus can cause a chronic carrier state. Perinatal transmission is possible but uncommon. Of greatest importance, the immunoprophylaxis described for hepatitis B is almost perfectly protective against perinatal transmission of hepatitis D.1,2

Continue to: Hepatitis E...

 

 

Hepatitis E

Hepatitis E is an RNA virus that has 1 serotype and 4 genotypes. Its epidemiology is similar to that of hepatitis A. It is the most common waterborne illness in the world. The incubation period varies from 21 to 56 days. This disease is quite rare in the United States but is endemic in developing nations. In those countries, maternal infection has an alarmingly high mortality rate (5%–25%). For example, in Bangladesh, hepatitis E is responsible for more than 1,000 deaths per year in pregnant women. When hepatitis E is identified in more affluent countries, the individual cases and small outbreaks usually are linked to consumption of undercooked pork or wild game.1,15-17

The clinical presentation of acute hepatitis E also is similar to that of hepatitis A. The usual manifestations are fever, malaise, anorexia, nausea, right upper quadrant pain and tenderness, jaundice, darkened urine, and clay-colored stools. The most useful diagnostic tests are serologic detection of viral-specific antibodies (positive IgM or a 4-fold increase in the prior IgG titer) and PCR-RNA.1,17

Hepatitis E usually does not cause a chronic carrier state, and perinatal transmission is rare. Fortunately, a highly effective vaccine was recently developed (Hecolin, Xiamen Innovax Biotech). This recombinant vaccine is specifically directed against the hepatitis E genotype 1. In the initial efficacy study, healthy adults aged 16 to 65 years were randomly assigned to receive either the hepatitis E vaccine or the hepatitis B vaccine. The vaccine was administered at time point 0, and 1 and 6 months later. Patients were followed for up to 4.5 years to assess efficacy, immunogenicity, and safety. During the study period, 7 cases of hepatitis E occurred in the vaccine group, compared with 53 in the control group. Approximately 56,000 patients were included in each group. The efficacy of the vaccine was 86.8% (P<.001).18

Hepatitis G

Hepatitis G is caused by 2 single-stranded RNA viruses that are virtually identical—hepatitis G virus and GB virus type C. The viruses share approximately 30% homology with hepatitis C virus. The organism is present throughout the world and infects approximately 1.5% to 2.0% of the population. The virus is transmitted by blood and sexual contact. It replicates preferentially in mononuclear cells and the bone marrow rather than in the liver.19-21

Hepatitis G is much less virulent than hepatitis C. Hepatitis G often coexists with hepatitis A, B, and C, as well as with HIV. Coinfection with hepatitis G does not adversely affect the clinical course of the other conditions.22,23

Most patients with hepatitis G are asymptomatic, and no treatment is indicated. The virus can cause a chronic carrier state. Perinatal transmission is distinctly uncommon. When it does occur, however, injury to mother, fetus, or neonate is unlikely.1,24

The diagnosis of hepatitis G can be established by detection of virus with PCR and by the identification of antibody by enzyme immunoassay. Routine screening for this infection in pregnancy is not indicated.1,2

CASE Resolved

Hepatitis B is highly contagious and can be transmitted from the patient to her sexual partner and neonate. Testing for hepatitis B surface antigen and antibody is indicated in her partner. If these tests are negative, the partner should immediately receive hepatitis B immune globulin and then be started on the 3-dose hepatitis B vaccination series. The patient’s newborn also should receive hepatitis B immune globulin within 12 hours of delivery and should receive the first dose of the hepatitis B vaccine prior to discharge from the hospital. The second and third doses should be administered 1 and 6 months after delivery.

The patient also should have the following tests:

liver function tests

-serum transaminases

-direct and indirect bilirubin

-coagulation profile

hepatitis D antigen

hepatitis B genotype

hepatitis B viral load

HIV serology.

If the hepatitis B viral load exceeds 1 million copies/mL, the patient should be treated with tenofovir 200 mg daily from 28 weeks’ gestation until delivery. In addition, she should be referred to a liver disease specialist after delivery for consideration of treatment with directly-acting antiviral agents.

 

References
  1. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TB, et al, eds. Creasy & Resnik’s MaternalFetal Medicine Principles and Practice. 8th ed. Elsevier; 2019:862-919.
  2. Duff P. Hepatitis in pregnancy. In: Queenan JR, Spong CY, Lockwood CJ, eds. Management of HighRisk Pregnancy. An EvidenceBased Approach. 5th ed. Blackwell; 2007:238-241.
  3. Duff B, Duff P. Hepatitis A vaccine: ready for prime time. Obstet Gynecol. 1998;91:468-471.
  4. Victor JC, Monto AS, Surdina TY, et al. Hepatitis A vaccine versus immune globulin for postexposure prophylaxis. N Engl J Med. 2007;367:1685-1694.
  5. Dienstag JL. Hepatitis B virus infection. N Engl J Med. 2008;359:1486-1500.
  6. Society for MaternalFetal Medicine (SMFM); Dionne-Odom J, Tita ATN, Silverman NS. #38. Hepatitis B in pregnancy: screening, treatment, and prevention of vertical transmission. Am J Obstet Gynecol. 2016;214:6-14.
  7. Pan CQ, Duan Z, Dai E, et al. Tenofovir to prevent hepatitis B transmission in mothers with high viral load. N Engl J Med. 2016;374:2324-2334.
  8. Jourdain G, Huong N, Harrison L, et al. Tenofovir versus placebo to prevent perinatal transmission of hepatitis B. N Engl J Med. 2018;378:911-923.
  9. Rosen HR. Chronic hepatitis C infection. N Engl J Med. 2011;364:2429-2438.
  10. Hoofnagle JH, Feinstore SM. The discovery of hepatitis C—the 2020 Nobel Prize in Physiology or Medicine. N Engl J Med. 2020;384:2297-2299.
  11. Hughes BL, Page CM, Juller JA. Hepatitis C in pregnancy: screening, treatment, and management. Am J Obstet Gynecol. 2017;217:B2-B12.
  12. Saab S, Kullar R, Gounder P. The urgent need for hepatitis C screening in pregnant women: a call to action. Obstet Gynecol. 2020;135:773-777.
  13. Berkley EMF, Leslie KK, Arora S, et al. Chronic hepatitis C in pregnancy. Obstet Gynecol. 2008;112:304-310.
  14. Brazel M, Duff P. Considerations on the mode of delivery for pregnant women with hepatitis C infection [published online November 22, 2019]. OBG Manag. 2020;32:39-44.
  15. Emerson SU, Purcell RH. Hepatitis E virus. Rev Med Virol. 2003;13:145-154.
  16. Khuroo MS, Teli MR, Skidmore S, et al. Incidence and severity of viral hepatitis in pregnancy. Am J Med. 1981;70:252-255.
  17. Hoofnangle JH, Nelson KE, Purcell RH. Hepatitis E. N Engl J Med. 2012;367:1237-1244.
  18. Zhang J, Zhang XF, Huang SJ, et al. Longterm efficacy of a hepatitis E vaccine. N Engl J Med. 2015;372:914-922.
  19. Pickering L, ed. Red Book 2000 Report of Committee on Infectious Diseases. 25th ed. American Academy of Pediatrics; 2000.
  20. Chopra S. GB virus C (hepatitis G) infection. UpToDate website. Updated January 16, 2020. Accessed June 3, 2021. https://www.uptodate.com/contents/gb-virus-c-hepatitis-g-infection.
  21. Reshetnyak VI, Karlovich TI, Ilchenko LU. Hepatitis G virus. World J Gastroenterol. 2008;14:4725-4734.
  22. Kew MC, Kassianides C. HGV: hepatitis G virus or harmless G virus. Lancet. 1996;348(suppl II):10.
  23. Jarvis LM, Davidson F, Hanley JP, et al. Infection with hepatitis G virus among recipients of plasma products. Lancet. 1996;348;1352-1355.
  24. Feucht HH, Zollner B, Polywka S, et al. Vertical transmission of hepatitis G. Lancet. 1996;347;615-616.
Article PDF
Author and Disclosure Information

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine.

The author reports no financial relationships relevant to this article.

Issue
OBG Management - 33(7)
Publications
Topics
Page Number
27, 30-33, 47
Sections
Author and Disclosure Information

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine.

The author reports no financial relationships relevant to this article.

Author and Disclosure Information

Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine.

The author reports no financial relationships relevant to this article.

Article PDF
Article PDF

 

 

CASE Pregnant woman with positive hepatitis B surface antigen

A 27-year-old primigravida at 9 weeks 3 days of gestation tests positive for the hepatitis B surface antigen at her first prenatal appointment. She is completely asymptomatic.

  • What additional tests are indicated?

 

  • Does she pose a risk to her sexual partner, and is her newborn at risk for acquiring hepatitis B?

 

  • Can anything be done to protect her partner and newborn from infection?

Meet our perpetrator

Hepatitis is one of the more common viral infections that may occur during pregnancy. Two forms of hepatitis, notably hepatitis A and E, pose a primary threat to the mother. Three forms (B, C, and D) present dangers for the mother, fetus, and newborn. This article will review the epidemiology, clinical manifestations, perinatal implications, and management of the various forms of viral hepatitis. (TABLE 1).

Hepatitis A

Hepatitis A is caused by an RNA virus that is transmitted by fecal-oral contact. The disease is most prevalent in areas with poor sanitation and close living conditions. The incubation period ranges from 15 to 50 days. Most children who acquire this disease are asymptomatic. By contrast, most infected adults are acutely symptomatic. Clinical manifestations typically include low-grade fever, malaise, anorexia, right upper quadrant pain and tenderness, jaundice, and claycolored stools.1,2

The diagnosis of acute hepatitis A infection is best confirmed by detection of immunoglobulin M (IgM)-specific antibodies. The serum transaminase concentrations and the serum bilirubin concentrations usually are significantly elevated. The international normalized ratio, prothrombin time, and partial thromboplastin time also may be elevated.1,2

The treatment for acute hepatitis A largely is supportive care: maintaining hydration, optimizing nutrition, and correcting coagulation abnormalities. The appropriate measures for prevention of hepatitis A are adoption of sound sanitation practices, particularly water purification; minimizing overcrowded living conditions; and administering the hepatitis A vaccine for both pre and postexposure prophylaxis.3,4 The hepatitis A vaccine is preferred over administration of immune globulin because it provides lifelong immunity.

The hepatitis A vaccine is produced in 2 monovalent formulations: Havrix (GlaxoSmithKline) and Vaqta (Merck & Co, Inc). The vaccine should be administered intramuscularly in 2 doses 6 to 12 months apart. The wholesale cost of the vaccine varies from $66 to $119 (according to http://www.goodrx.com). The vaccine also is available in a bivalent form, with recombinant hepatitis B vaccine (Twinrix, GlaxoSmithKline). When used in this form, 3 vaccine administrations are given—at 0, 1, and 6 months apart. The cost of the vaccine is approximately $150 (according to http://www.goodrx.com). TABLE 2 lists the individuals who are appropriate candidates for the hepatitis A vaccine.3,4

Hepatitis B

Hepatitis B is caused by a DNA virus that is transmitted parenterally or perinatally or through sexual contact. Four genotypes have been identified: A, B, C, and D.

Acute hepatitis B affects 1 to 2 of 1,000 pregnancies in the United States. Approximately 6 to 10 patients per 1,000 pregnancies are asymptomatic but chronically infected.4 The natural history of hepatitis B infection is shown in the FIGURE. The diagnosis of acute and chronic hepatitis B is best established by serology and polymerase chain reaction (PCR; TABLE 3).



All pregnant women should be routinely screened for the hepatitis B surface antigen.5,6 If they are seropositive for the surface antigen alone and receive no immunoprophylaxis, they have a 20% to 30% risk of transmitting infection to their neonate. Subsequently, if they also test positive for the hepatitis Be antigen, the risk of perinatal transmission increases to approximately 90%. Fortunately, 2 forms of immunoprophylaxis are highly effective in preventing perinatal transmission. Infants delivered to seropositive mothers should receive hepatitis B immune globulin within 12 hours of birth. Prior to discharge, the infant also should receive the first dose of the hepatitis B vaccine. Subsequent doses should be administered at 1 and 6 months of age. Infants delivered to seronegative mothers require only the vaccine series.1

Although immunoprophylaxis is highly effective, some neonates still acquire infection perinatally. Pan and colleagues7 and Jourdain et al8 demonstrated that administration of tenofovir 200 mg orally each day from 32 weeks’ gestation until delivery provided further protection against perinatal transmission in patients with a high viral load (defined as >1 million copies/mL). In 2016, the Society for Maternal-Fetal Medicine endorsed the use of tenofovir in women with a high viral load.6

Following delivery, women with chronic hepatitis B infection should be referred to a hepatology specialist for consideration of direct antiviral treatment. Multiple drugs are now available that are highly active against this micro-organism. These drugs include several forms of interferon, lamivudine, adefovir, entecavir, telbivudine, and tenofovir.1

Continue to: Hepatitis C...

 

 

Hepatitis C

Hepatitis C is caused by an RNA virus that has 6 genotypes. The most common genotype is HCV1, which affects 79% of patients; approximately 13% of patients have HCV2, and 6% have HCV3.9 Of note, the 3 individuals who discovered this virus—Drs. Harvey Alter, Michael Houghton, and Charles Rice—received the 2020 Nobel Prize in Medicine.10

Hepatitis C is transmitted via sexual contact, parenterally, and perinatally. In many patient populations in the United States, hepatitis C is now more prevalent than hepatitis B. Only about half of all infected persons are aware of their infection. If patients go untreated, approximately 15% to 30% eventually develop cirrhosis. Of these individuals, 1% to 3% develop hepatocellular cancer. Chronic hepatitis C is now the most common indication for liver transplantation in the United States.1,9

In the initial stages of infection, hepatitis C usually is asymptomatic. The best screening test is detection of hepatitis C antibody. Because of the increasing prevalence of this disease, the seriousness of the infection, and the recent availability of remarkably effective treatment, routine screening, rather than screening on the basis of risk factors, for hepatitis C in pregnancy is now indicated.11,12

The best tests for confirmation of infection are detection of antibody by enzyme immunoassay and recombinant immuno-blot assay and detection of viral RNA in serum by PCR. Seroconversion may not occur for up to 16 weeks after infection. Therefore, in at-risk patients who initially test negative, retesting is advisable. Patients with positive test results should have tests to identify the specific genotype, determine the viral load, and assess liver function.1

In patients who have undetectable viral loads and who do not have coexisting HIV infection, the risk of perinatal transmission of hepatitis C is less than 5%. If HIV infection is present, the risk of perinatal transmission approaches 20%.1,13,14

If the patient is coinfected with HIV, a scheduled cesarean delivery should be performed at 38 weeks’ gestation.1 If the viral load is undetectable, vaginal delivery is appropriate. If the viral load is high, however (arbitrarily defined as >2.5 millioncopies/mL), the optimal method of delivery is controversial. Several small, nonrandomized noncontrolled cohort studies support elective cesarean delivery in such patients.14

There is no contraindication to breastfeeding in women with hepatitis C unless they are coinfected with HIV. In such a circumstance, formula feeding should be chosen. After delivery, patients with hepatitis C should be referred to a gastroenterology specialist to receive antiviral treatment. Multiple new single-agent and combination regimens have produced cures in more than 90% of patients. These regimens usually require 8 to 12 weeks of treatment, and they are very expensive. They have not been widely tested in pregnant women.1

Hepatitis D

Hepatitis D, or delta hepatitis, is caused by an RNA virus. This virus is unique because it is incapable of independent replication. It must be present in association with hepatitis B to replicate and cause clinical infection. Therefore, the epidemiology of hepatitis D closely mirrors that of hepatitis B.1,2

Patients with hepatitis D typically present in one of two ways. Some individuals are acutely infected with hepatitis D at the same time that they acquire hepatitis B (coinfection). The natural history of this infection usually is spontaneous resolution without sequelae. Other patients have chronic hepatitis D superimposed on chronic hepatitis B (superinfection). Unfortunately, patients with the latter condition are at a notably increased risk for developing severe persistent liver disease.1,2

The diagnosis of hepatitis D may be confirmed by identifying the delta antigen in serum or in liver tissue obtained by biopsy or by identifying IgM- and IgG-specific antibodies in serum. In conjunction with hepatitis B, the delta virus can cause a chronic carrier state. Perinatal transmission is possible but uncommon. Of greatest importance, the immunoprophylaxis described for hepatitis B is almost perfectly protective against perinatal transmission of hepatitis D.1,2

Continue to: Hepatitis E...

 

 

Hepatitis E

Hepatitis E is an RNA virus that has 1 serotype and 4 genotypes. Its epidemiology is similar to that of hepatitis A. It is the most common waterborne illness in the world. The incubation period varies from 21 to 56 days. This disease is quite rare in the United States but is endemic in developing nations. In those countries, maternal infection has an alarmingly high mortality rate (5%–25%). For example, in Bangladesh, hepatitis E is responsible for more than 1,000 deaths per year in pregnant women. When hepatitis E is identified in more affluent countries, the individual cases and small outbreaks usually are linked to consumption of undercooked pork or wild game.1,15-17

The clinical presentation of acute hepatitis E also is similar to that of hepatitis A. The usual manifestations are fever, malaise, anorexia, nausea, right upper quadrant pain and tenderness, jaundice, darkened urine, and clay-colored stools. The most useful diagnostic tests are serologic detection of viral-specific antibodies (positive IgM or a 4-fold increase in the prior IgG titer) and PCR-RNA.1,17

Hepatitis E usually does not cause a chronic carrier state, and perinatal transmission is rare. Fortunately, a highly effective vaccine was recently developed (Hecolin, Xiamen Innovax Biotech). This recombinant vaccine is specifically directed against the hepatitis E genotype 1. In the initial efficacy study, healthy adults aged 16 to 65 years were randomly assigned to receive either the hepatitis E vaccine or the hepatitis B vaccine. The vaccine was administered at time point 0, and 1 and 6 months later. Patients were followed for up to 4.5 years to assess efficacy, immunogenicity, and safety. During the study period, 7 cases of hepatitis E occurred in the vaccine group, compared with 53 in the control group. Approximately 56,000 patients were included in each group. The efficacy of the vaccine was 86.8% (P<.001).18

Hepatitis G

Hepatitis G is caused by 2 single-stranded RNA viruses that are virtually identical—hepatitis G virus and GB virus type C. The viruses share approximately 30% homology with hepatitis C virus. The organism is present throughout the world and infects approximately 1.5% to 2.0% of the population. The virus is transmitted by blood and sexual contact. It replicates preferentially in mononuclear cells and the bone marrow rather than in the liver.19-21

Hepatitis G is much less virulent than hepatitis C. Hepatitis G often coexists with hepatitis A, B, and C, as well as with HIV. Coinfection with hepatitis G does not adversely affect the clinical course of the other conditions.22,23

Most patients with hepatitis G are asymptomatic, and no treatment is indicated. The virus can cause a chronic carrier state. Perinatal transmission is distinctly uncommon. When it does occur, however, injury to mother, fetus, or neonate is unlikely.1,24

The diagnosis of hepatitis G can be established by detection of virus with PCR and by the identification of antibody by enzyme immunoassay. Routine screening for this infection in pregnancy is not indicated.1,2

CASE Resolved

Hepatitis B is highly contagious and can be transmitted from the patient to her sexual partner and neonate. Testing for hepatitis B surface antigen and antibody is indicated in her partner. If these tests are negative, the partner should immediately receive hepatitis B immune globulin and then be started on the 3-dose hepatitis B vaccination series. The patient’s newborn also should receive hepatitis B immune globulin within 12 hours of delivery and should receive the first dose of the hepatitis B vaccine prior to discharge from the hospital. The second and third doses should be administered 1 and 6 months after delivery.

The patient also should have the following tests:

liver function tests

-serum transaminases

-direct and indirect bilirubin

-coagulation profile

hepatitis D antigen

hepatitis B genotype

hepatitis B viral load

HIV serology.

If the hepatitis B viral load exceeds 1 million copies/mL, the patient should be treated with tenofovir 200 mg daily from 28 weeks’ gestation until delivery. In addition, she should be referred to a liver disease specialist after delivery for consideration of treatment with directly-acting antiviral agents.

 

 

 

CASE Pregnant woman with positive hepatitis B surface antigen

A 27-year-old primigravida at 9 weeks 3 days of gestation tests positive for the hepatitis B surface antigen at her first prenatal appointment. She is completely asymptomatic.

  • What additional tests are indicated?

 

  • Does she pose a risk to her sexual partner, and is her newborn at risk for acquiring hepatitis B?

 

  • Can anything be done to protect her partner and newborn from infection?

Meet our perpetrator

Hepatitis is one of the more common viral infections that may occur during pregnancy. Two forms of hepatitis, notably hepatitis A and E, pose a primary threat to the mother. Three forms (B, C, and D) present dangers for the mother, fetus, and newborn. This article will review the epidemiology, clinical manifestations, perinatal implications, and management of the various forms of viral hepatitis. (TABLE 1).

Hepatitis A

Hepatitis A is caused by an RNA virus that is transmitted by fecal-oral contact. The disease is most prevalent in areas with poor sanitation and close living conditions. The incubation period ranges from 15 to 50 days. Most children who acquire this disease are asymptomatic. By contrast, most infected adults are acutely symptomatic. Clinical manifestations typically include low-grade fever, malaise, anorexia, right upper quadrant pain and tenderness, jaundice, and claycolored stools.1,2

The diagnosis of acute hepatitis A infection is best confirmed by detection of immunoglobulin M (IgM)-specific antibodies. The serum transaminase concentrations and the serum bilirubin concentrations usually are significantly elevated. The international normalized ratio, prothrombin time, and partial thromboplastin time also may be elevated.1,2

The treatment for acute hepatitis A largely is supportive care: maintaining hydration, optimizing nutrition, and correcting coagulation abnormalities. The appropriate measures for prevention of hepatitis A are adoption of sound sanitation practices, particularly water purification; minimizing overcrowded living conditions; and administering the hepatitis A vaccine for both pre and postexposure prophylaxis.3,4 The hepatitis A vaccine is preferred over administration of immune globulin because it provides lifelong immunity.

The hepatitis A vaccine is produced in 2 monovalent formulations: Havrix (GlaxoSmithKline) and Vaqta (Merck & Co, Inc). The vaccine should be administered intramuscularly in 2 doses 6 to 12 months apart. The wholesale cost of the vaccine varies from $66 to $119 (according to http://www.goodrx.com). The vaccine also is available in a bivalent form, with recombinant hepatitis B vaccine (Twinrix, GlaxoSmithKline). When used in this form, 3 vaccine administrations are given—at 0, 1, and 6 months apart. The cost of the vaccine is approximately $150 (according to http://www.goodrx.com). TABLE 2 lists the individuals who are appropriate candidates for the hepatitis A vaccine.3,4

Hepatitis B

Hepatitis B is caused by a DNA virus that is transmitted parenterally or perinatally or through sexual contact. Four genotypes have been identified: A, B, C, and D.

Acute hepatitis B affects 1 to 2 of 1,000 pregnancies in the United States. Approximately 6 to 10 patients per 1,000 pregnancies are asymptomatic but chronically infected.4 The natural history of hepatitis B infection is shown in the FIGURE. The diagnosis of acute and chronic hepatitis B is best established by serology and polymerase chain reaction (PCR; TABLE 3).



All pregnant women should be routinely screened for the hepatitis B surface antigen.5,6 If they are seropositive for the surface antigen alone and receive no immunoprophylaxis, they have a 20% to 30% risk of transmitting infection to their neonate. Subsequently, if they also test positive for the hepatitis Be antigen, the risk of perinatal transmission increases to approximately 90%. Fortunately, 2 forms of immunoprophylaxis are highly effective in preventing perinatal transmission. Infants delivered to seropositive mothers should receive hepatitis B immune globulin within 12 hours of birth. Prior to discharge, the infant also should receive the first dose of the hepatitis B vaccine. Subsequent doses should be administered at 1 and 6 months of age. Infants delivered to seronegative mothers require only the vaccine series.1

Although immunoprophylaxis is highly effective, some neonates still acquire infection perinatally. Pan and colleagues7 and Jourdain et al8 demonstrated that administration of tenofovir 200 mg orally each day from 32 weeks’ gestation until delivery provided further protection against perinatal transmission in patients with a high viral load (defined as >1 million copies/mL). In 2016, the Society for Maternal-Fetal Medicine endorsed the use of tenofovir in women with a high viral load.6

Following delivery, women with chronic hepatitis B infection should be referred to a hepatology specialist for consideration of direct antiviral treatment. Multiple drugs are now available that are highly active against this micro-organism. These drugs include several forms of interferon, lamivudine, adefovir, entecavir, telbivudine, and tenofovir.1

Continue to: Hepatitis C...

 

 

Hepatitis C

Hepatitis C is caused by an RNA virus that has 6 genotypes. The most common genotype is HCV1, which affects 79% of patients; approximately 13% of patients have HCV2, and 6% have HCV3.9 Of note, the 3 individuals who discovered this virus—Drs. Harvey Alter, Michael Houghton, and Charles Rice—received the 2020 Nobel Prize in Medicine.10

Hepatitis C is transmitted via sexual contact, parenterally, and perinatally. In many patient populations in the United States, hepatitis C is now more prevalent than hepatitis B. Only about half of all infected persons are aware of their infection. If patients go untreated, approximately 15% to 30% eventually develop cirrhosis. Of these individuals, 1% to 3% develop hepatocellular cancer. Chronic hepatitis C is now the most common indication for liver transplantation in the United States.1,9

In the initial stages of infection, hepatitis C usually is asymptomatic. The best screening test is detection of hepatitis C antibody. Because of the increasing prevalence of this disease, the seriousness of the infection, and the recent availability of remarkably effective treatment, routine screening, rather than screening on the basis of risk factors, for hepatitis C in pregnancy is now indicated.11,12

The best tests for confirmation of infection are detection of antibody by enzyme immunoassay and recombinant immuno-blot assay and detection of viral RNA in serum by PCR. Seroconversion may not occur for up to 16 weeks after infection. Therefore, in at-risk patients who initially test negative, retesting is advisable. Patients with positive test results should have tests to identify the specific genotype, determine the viral load, and assess liver function.1

In patients who have undetectable viral loads and who do not have coexisting HIV infection, the risk of perinatal transmission of hepatitis C is less than 5%. If HIV infection is present, the risk of perinatal transmission approaches 20%.1,13,14

If the patient is coinfected with HIV, a scheduled cesarean delivery should be performed at 38 weeks’ gestation.1 If the viral load is undetectable, vaginal delivery is appropriate. If the viral load is high, however (arbitrarily defined as >2.5 millioncopies/mL), the optimal method of delivery is controversial. Several small, nonrandomized noncontrolled cohort studies support elective cesarean delivery in such patients.14

There is no contraindication to breastfeeding in women with hepatitis C unless they are coinfected with HIV. In such a circumstance, formula feeding should be chosen. After delivery, patients with hepatitis C should be referred to a gastroenterology specialist to receive antiviral treatment. Multiple new single-agent and combination regimens have produced cures in more than 90% of patients. These regimens usually require 8 to 12 weeks of treatment, and they are very expensive. They have not been widely tested in pregnant women.1

Hepatitis D

Hepatitis D, or delta hepatitis, is caused by an RNA virus. This virus is unique because it is incapable of independent replication. It must be present in association with hepatitis B to replicate and cause clinical infection. Therefore, the epidemiology of hepatitis D closely mirrors that of hepatitis B.1,2

Patients with hepatitis D typically present in one of two ways. Some individuals are acutely infected with hepatitis D at the same time that they acquire hepatitis B (coinfection). The natural history of this infection usually is spontaneous resolution without sequelae. Other patients have chronic hepatitis D superimposed on chronic hepatitis B (superinfection). Unfortunately, patients with the latter condition are at a notably increased risk for developing severe persistent liver disease.1,2

The diagnosis of hepatitis D may be confirmed by identifying the delta antigen in serum or in liver tissue obtained by biopsy or by identifying IgM- and IgG-specific antibodies in serum. In conjunction with hepatitis B, the delta virus can cause a chronic carrier state. Perinatal transmission is possible but uncommon. Of greatest importance, the immunoprophylaxis described for hepatitis B is almost perfectly protective against perinatal transmission of hepatitis D.1,2

Continue to: Hepatitis E...

 

 

Hepatitis E

Hepatitis E is an RNA virus that has 1 serotype and 4 genotypes. Its epidemiology is similar to that of hepatitis A. It is the most common waterborne illness in the world. The incubation period varies from 21 to 56 days. This disease is quite rare in the United States but is endemic in developing nations. In those countries, maternal infection has an alarmingly high mortality rate (5%–25%). For example, in Bangladesh, hepatitis E is responsible for more than 1,000 deaths per year in pregnant women. When hepatitis E is identified in more affluent countries, the individual cases and small outbreaks usually are linked to consumption of undercooked pork or wild game.1,15-17

The clinical presentation of acute hepatitis E also is similar to that of hepatitis A. The usual manifestations are fever, malaise, anorexia, nausea, right upper quadrant pain and tenderness, jaundice, darkened urine, and clay-colored stools. The most useful diagnostic tests are serologic detection of viral-specific antibodies (positive IgM or a 4-fold increase in the prior IgG titer) and PCR-RNA.1,17

Hepatitis E usually does not cause a chronic carrier state, and perinatal transmission is rare. Fortunately, a highly effective vaccine was recently developed (Hecolin, Xiamen Innovax Biotech). This recombinant vaccine is specifically directed against the hepatitis E genotype 1. In the initial efficacy study, healthy adults aged 16 to 65 years were randomly assigned to receive either the hepatitis E vaccine or the hepatitis B vaccine. The vaccine was administered at time point 0, and 1 and 6 months later. Patients were followed for up to 4.5 years to assess efficacy, immunogenicity, and safety. During the study period, 7 cases of hepatitis E occurred in the vaccine group, compared with 53 in the control group. Approximately 56,000 patients were included in each group. The efficacy of the vaccine was 86.8% (P<.001).18

Hepatitis G

Hepatitis G is caused by 2 single-stranded RNA viruses that are virtually identical—hepatitis G virus and GB virus type C. The viruses share approximately 30% homology with hepatitis C virus. The organism is present throughout the world and infects approximately 1.5% to 2.0% of the population. The virus is transmitted by blood and sexual contact. It replicates preferentially in mononuclear cells and the bone marrow rather than in the liver.19-21

Hepatitis G is much less virulent than hepatitis C. Hepatitis G often coexists with hepatitis A, B, and C, as well as with HIV. Coinfection with hepatitis G does not adversely affect the clinical course of the other conditions.22,23

Most patients with hepatitis G are asymptomatic, and no treatment is indicated. The virus can cause a chronic carrier state. Perinatal transmission is distinctly uncommon. When it does occur, however, injury to mother, fetus, or neonate is unlikely.1,24

The diagnosis of hepatitis G can be established by detection of virus with PCR and by the identification of antibody by enzyme immunoassay. Routine screening for this infection in pregnancy is not indicated.1,2

CASE Resolved

Hepatitis B is highly contagious and can be transmitted from the patient to her sexual partner and neonate. Testing for hepatitis B surface antigen and antibody is indicated in her partner. If these tests are negative, the partner should immediately receive hepatitis B immune globulin and then be started on the 3-dose hepatitis B vaccination series. The patient’s newborn also should receive hepatitis B immune globulin within 12 hours of delivery and should receive the first dose of the hepatitis B vaccine prior to discharge from the hospital. The second and third doses should be administered 1 and 6 months after delivery.

The patient also should have the following tests:

liver function tests

-serum transaminases

-direct and indirect bilirubin

-coagulation profile

hepatitis D antigen

hepatitis B genotype

hepatitis B viral load

HIV serology.

If the hepatitis B viral load exceeds 1 million copies/mL, the patient should be treated with tenofovir 200 mg daily from 28 weeks’ gestation until delivery. In addition, she should be referred to a liver disease specialist after delivery for consideration of treatment with directly-acting antiviral agents.

 

References
  1. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TB, et al, eds. Creasy & Resnik’s MaternalFetal Medicine Principles and Practice. 8th ed. Elsevier; 2019:862-919.
  2. Duff P. Hepatitis in pregnancy. In: Queenan JR, Spong CY, Lockwood CJ, eds. Management of HighRisk Pregnancy. An EvidenceBased Approach. 5th ed. Blackwell; 2007:238-241.
  3. Duff B, Duff P. Hepatitis A vaccine: ready for prime time. Obstet Gynecol. 1998;91:468-471.
  4. Victor JC, Monto AS, Surdina TY, et al. Hepatitis A vaccine versus immune globulin for postexposure prophylaxis. N Engl J Med. 2007;367:1685-1694.
  5. Dienstag JL. Hepatitis B virus infection. N Engl J Med. 2008;359:1486-1500.
  6. Society for MaternalFetal Medicine (SMFM); Dionne-Odom J, Tita ATN, Silverman NS. #38. Hepatitis B in pregnancy: screening, treatment, and prevention of vertical transmission. Am J Obstet Gynecol. 2016;214:6-14.
  7. Pan CQ, Duan Z, Dai E, et al. Tenofovir to prevent hepatitis B transmission in mothers with high viral load. N Engl J Med. 2016;374:2324-2334.
  8. Jourdain G, Huong N, Harrison L, et al. Tenofovir versus placebo to prevent perinatal transmission of hepatitis B. N Engl J Med. 2018;378:911-923.
  9. Rosen HR. Chronic hepatitis C infection. N Engl J Med. 2011;364:2429-2438.
  10. Hoofnagle JH, Feinstore SM. The discovery of hepatitis C—the 2020 Nobel Prize in Physiology or Medicine. N Engl J Med. 2020;384:2297-2299.
  11. Hughes BL, Page CM, Juller JA. Hepatitis C in pregnancy: screening, treatment, and management. Am J Obstet Gynecol. 2017;217:B2-B12.
  12. Saab S, Kullar R, Gounder P. The urgent need for hepatitis C screening in pregnant women: a call to action. Obstet Gynecol. 2020;135:773-777.
  13. Berkley EMF, Leslie KK, Arora S, et al. Chronic hepatitis C in pregnancy. Obstet Gynecol. 2008;112:304-310.
  14. Brazel M, Duff P. Considerations on the mode of delivery for pregnant women with hepatitis C infection [published online November 22, 2019]. OBG Manag. 2020;32:39-44.
  15. Emerson SU, Purcell RH. Hepatitis E virus. Rev Med Virol. 2003;13:145-154.
  16. Khuroo MS, Teli MR, Skidmore S, et al. Incidence and severity of viral hepatitis in pregnancy. Am J Med. 1981;70:252-255.
  17. Hoofnangle JH, Nelson KE, Purcell RH. Hepatitis E. N Engl J Med. 2012;367:1237-1244.
  18. Zhang J, Zhang XF, Huang SJ, et al. Longterm efficacy of a hepatitis E vaccine. N Engl J Med. 2015;372:914-922.
  19. Pickering L, ed. Red Book 2000 Report of Committee on Infectious Diseases. 25th ed. American Academy of Pediatrics; 2000.
  20. Chopra S. GB virus C (hepatitis G) infection. UpToDate website. Updated January 16, 2020. Accessed June 3, 2021. https://www.uptodate.com/contents/gb-virus-c-hepatitis-g-infection.
  21. Reshetnyak VI, Karlovich TI, Ilchenko LU. Hepatitis G virus. World J Gastroenterol. 2008;14:4725-4734.
  22. Kew MC, Kassianides C. HGV: hepatitis G virus or harmless G virus. Lancet. 1996;348(suppl II):10.
  23. Jarvis LM, Davidson F, Hanley JP, et al. Infection with hepatitis G virus among recipients of plasma products. Lancet. 1996;348;1352-1355.
  24. Feucht HH, Zollner B, Polywka S, et al. Vertical transmission of hepatitis G. Lancet. 1996;347;615-616.
References
  1. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TB, et al, eds. Creasy & Resnik’s MaternalFetal Medicine Principles and Practice. 8th ed. Elsevier; 2019:862-919.
  2. Duff P. Hepatitis in pregnancy. In: Queenan JR, Spong CY, Lockwood CJ, eds. Management of HighRisk Pregnancy. An EvidenceBased Approach. 5th ed. Blackwell; 2007:238-241.
  3. Duff B, Duff P. Hepatitis A vaccine: ready for prime time. Obstet Gynecol. 1998;91:468-471.
  4. Victor JC, Monto AS, Surdina TY, et al. Hepatitis A vaccine versus immune globulin for postexposure prophylaxis. N Engl J Med. 2007;367:1685-1694.
  5. Dienstag JL. Hepatitis B virus infection. N Engl J Med. 2008;359:1486-1500.
  6. Society for MaternalFetal Medicine (SMFM); Dionne-Odom J, Tita ATN, Silverman NS. #38. Hepatitis B in pregnancy: screening, treatment, and prevention of vertical transmission. Am J Obstet Gynecol. 2016;214:6-14.
  7. Pan CQ, Duan Z, Dai E, et al. Tenofovir to prevent hepatitis B transmission in mothers with high viral load. N Engl J Med. 2016;374:2324-2334.
  8. Jourdain G, Huong N, Harrison L, et al. Tenofovir versus placebo to prevent perinatal transmission of hepatitis B. N Engl J Med. 2018;378:911-923.
  9. Rosen HR. Chronic hepatitis C infection. N Engl J Med. 2011;364:2429-2438.
  10. Hoofnagle JH, Feinstore SM. The discovery of hepatitis C—the 2020 Nobel Prize in Physiology or Medicine. N Engl J Med. 2020;384:2297-2299.
  11. Hughes BL, Page CM, Juller JA. Hepatitis C in pregnancy: screening, treatment, and management. Am J Obstet Gynecol. 2017;217:B2-B12.
  12. Saab S, Kullar R, Gounder P. The urgent need for hepatitis C screening in pregnant women: a call to action. Obstet Gynecol. 2020;135:773-777.
  13. Berkley EMF, Leslie KK, Arora S, et al. Chronic hepatitis C in pregnancy. Obstet Gynecol. 2008;112:304-310.
  14. Brazel M, Duff P. Considerations on the mode of delivery for pregnant women with hepatitis C infection [published online November 22, 2019]. OBG Manag. 2020;32:39-44.
  15. Emerson SU, Purcell RH. Hepatitis E virus. Rev Med Virol. 2003;13:145-154.
  16. Khuroo MS, Teli MR, Skidmore S, et al. Incidence and severity of viral hepatitis in pregnancy. Am J Med. 1981;70:252-255.
  17. Hoofnangle JH, Nelson KE, Purcell RH. Hepatitis E. N Engl J Med. 2012;367:1237-1244.
  18. Zhang J, Zhang XF, Huang SJ, et al. Longterm efficacy of a hepatitis E vaccine. N Engl J Med. 2015;372:914-922.
  19. Pickering L, ed. Red Book 2000 Report of Committee on Infectious Diseases. 25th ed. American Academy of Pediatrics; 2000.
  20. Chopra S. GB virus C (hepatitis G) infection. UpToDate website. Updated January 16, 2020. Accessed June 3, 2021. https://www.uptodate.com/contents/gb-virus-c-hepatitis-g-infection.
  21. Reshetnyak VI, Karlovich TI, Ilchenko LU. Hepatitis G virus. World J Gastroenterol. 2008;14:4725-4734.
  22. Kew MC, Kassianides C. HGV: hepatitis G virus or harmless G virus. Lancet. 1996;348(suppl II):10.
  23. Jarvis LM, Davidson F, Hanley JP, et al. Infection with hepatitis G virus among recipients of plasma products. Lancet. 1996;348;1352-1355.
  24. Feucht HH, Zollner B, Polywka S, et al. Vertical transmission of hepatitis G. Lancet. 1996;347;615-616.
Issue
OBG Management - 33(7)
Issue
OBG Management - 33(7)
Page Number
27, 30-33, 47
Page Number
27, 30-33, 47
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

3 cases of hormone therapy optimized to match the patient problem

Article Type
Changed
Fri, 07/09/2021 - 14:17

There are dozens of medications containing combinations of estrogen and progestin. I am often confused by the bewildering proliferation of generic brand names used to describe the same estrogen-progestin (E-P) regimen. For example, the combination medication containing ethinyl estradiol 20 µg plus norethindrone acetate (NEA) 1 mg is available under at least 5 different names: Lo Estrin 1/20 (Warner Chilcot), Junel 1/20 (Teva Pharmaceuticals), Microgestin Fe 1/20 (Mayne Pharma), Gildess 1/20 (Qualitest Pharmaceuticals), and Larin 1/20 (Novast Laboratories). To reduce the confusion, it is often useful to select a single preferred estrogen and progestin and use the dose combinations that are available to treat a wide range of gynecology problems (TABLE). In this editorial I focus on using various dose combinations of ethinyl estradiol and NEA to treat 3 common gynecologic problems.

CASE 1 Polycystic ovary syndrome

A 19-year-old woman reports 4 spontaneous menses in the past year and bothersome facial hair and acne. Her total testosterone concentration is at the upper limit of normal (0.46 ng/mL) and her sex hormone binding globulin (SHBG) concentration is at the lower limit of normal (35 nM). For treatment of the patient’s menstrual disorder, what is an optimal E-P combination?

Prioritize the use of an estrogen-dominant medication

Based on the Rotterdam criteria this woman has polycystic ovary syndrome (PCOS).1 In women with PCOS, luteinizing hormone (LH) secretion is increased, stimulating excessive ovarian production of testosterone.2 In addition, many women with PCOS have decreased hepatic secretion of SHBG, a binding protein that prevents testosterone from entering cells, resulting in excessive bioavailable testosterone.3 The Endocrine Society recommends that women with PCOS who have menstrual dysfunction or hirsutism be treated initially with a combination E-P hormone medication.1 Combination E-P medications suppress pituitary secretion of LH, thereby reducing ovarian production of testosterone, and ethinyl estradiol increases hepatic secretion of SHBG, reducing bioavailable testosterone. These two goals are best accomplished with an oral E-P hormone medication containing ethinyl estradiol doses of 20 µg to 30 µg per pill. An E-P hormone medication containing pills with an ethinyl estradiol dose ≤ 10 µg-daily may stimulate less hepatic production of SHBG than a pill with an ethinyl estradiol dose of 20 µg or 30 µg daily.4,5 In addition, E-P pills containing levonorgestrel suppress SHBG hormone secretion compared with E-P pills with other progestins.6 Therefore, levonorgestrel-containing E-P pills should not be prioritized for use in women with PCOS because the estrogen-induced increase in SHBG will be blunted by levonorgestrel.

CASE 2 Moderate to severe pelvic pain caused by endometriosis

A 25-year-old woman (G0) with severe dysmenorrhea had a laparoscopy showing endometriosis lesions in the cul-de-sac and a peritoneal window near the left uterosacral ligament. Biopsy showed endometriosis. Postoperatively, the patient was treated with an E-P pill containing 30 µg ethinyl estradiol and 0.15 mg desogestrel per pill using a continuous-dosing protocol. During the year following the laparoscopy, her pelvic pain symptoms gradually increased until they became severe, preventing her from performing daily activities on multiple days per month. She was prescribed elagolix but her insurance did not approve the treatment. What alternative treatment would you prescribe?

Continue to: Use progestin-dominant pills to treat pelvic pain...

 

 

Use progestin-dominant pills to treat pelvic pain

Cellular activity in endometriosis lesions is stimulated by estradiol and inhibited by a high concentration of androgenic progestins or androgens. This simplified endocrine paradigm explains the effectiveness of hormonal treatments that suppress ovarian estradiol production, including leuprolide, elagolix, medroxyprogesterone acetate, and NEA. For the woman in the above case, I would advocate for elagolix treatment but, following the insurance denial of the prescription, an alternative treatment for moderate or severe pelvic pain caused by endometriosis would be a progestin-dominant hormone medication (for example, NEA 5 mg daily). Norethindrone acetate 5 mg daily may be associated with bothersome adverse effects including weight gain (16% of patients; mean weight gain, 3.1 kg), acne (10%), mood lability (9%), hot flashes (8%), depression (6%), scalp hair loss (4%), headache (4%), nausea (3%), and deepening of the voice (1%).7

I sometimes see women with moderate to severe pelvic pain caused by endometriosis being treated with norethindrone 0.35 mg daily. This dose of norethindrone is suboptimal for pain treatment because it does not reliably suppress ovarian production of estradiol. In addition, the cells in endometriosis lesions are often resistant to the effects of progesterone, requiring higher dosages to produce secretory or decidual changes. In most situations, I recommend against the use of norethindrone 0.35 mg daily for the treatment of pelvic pain caused by endometriosis.

Patients commonly ask if NEA 5 mg daily has contraceptive efficacy. Although it is not approved at this dosage by the US Food and Drug Administration as a contraceptive,8 norethindrone 0.35 mg daily is approved as a progestin-only contraceptive.9 Norethindrone acetate is rapidly and completely deacetylated to norethindrone and the disposition of oral NEA is indistinguishable from that of norethindrone (which is the FDA-approved dosage mentioned above). Since norethindrone 0.35 mg daily is approved as a contraceptive, it is highly likely that NEA 5 mg daily has contraceptive efficacy, especially if there is good adherence with the daily medication.

CASE 3 Perimenopausal AUB

A 45-year-old woman reports varying menstrual cycle lengths from 24 to 60 days with very heavy menses in some cycles. Pelvic ultrasonography shows no abnormality. Endometrial biopsy shows a proliferative endometrium. Her serum progesterone level, obtained 1 week before the onset of menses, is < 3 ng/mL. She has no past history of heavy menses, easy bruising, excessive bleeding with procedures, or a family history of bleeding problems. She also reports occasional hot flashes that wake her from sleep.

Use an estrogen step-down regimen to manage postmenopause transition

This patient is likely in the perimenopause transition, and the abnormal uterine bleeding (AUB) is caused, in part, by oligo- or anovulation. Perimenopausal women with AUB may have cycles characterized by above normal ovarian estradiol production and below normal progesterone production, or frank anovulation.10 Elevated ovarian estrogen and low progesterone production sets the stage for heavy bleeding in the perimenopause, regardless of the presence of uterine pathology such as fibroids.

For perimenopausal women, one option for treatment of AUB due to anovulation is to prescribe an estrogen step-down regimen. For the 45-year-old woman in this case, initiating treatment with an E-P pill containing ethinyl estradiol 10 µg and NEA 1 mg will likely control the AUB and her occasional hot flash.11 As the woman ages, the ethinyl estradiol dose can be decreased to pills containing 5 µg and then 2.5 µg, covering the transition into postmenopause. Once the woman is in the postmenopause, treatment with transdermal estradiol and oral micronized progesterone is an option to treat menopausal vasomotor symptoms.

 

Optimize estrogen and progestin treatment for your patients

Many gynecologic problems are effectively treated by estrogen and/or progestin steroids. The dose of estrogen and progestin should be tailored to the specific problem. For PCOS, the estrogen dose selected should be sufficient to safely stimulate hepatic SHBG production. For endometriosis, if a GnRH antagonist is not available to the patient, a high-dose progestin, such as NEA 5 mg, may be an effective treatment. During the perimenopause transition in a woman with AUB, a treatment plan using a sequential E-P step-down program might control symptoms and help smoothly glide the patient into the postmenopause. ●

References
  1. Legro RS, Arslanian SA, Ehrmann DA, et al. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98:4565-4592. doi: 10.1210/jc.2013-2350.
  2. Rosenfield RL, Ehrmann DA. The pathogenesis of polycystic ovary syndrome (PCOS): the hypothesis of PCOS as functional ovarian hyperandrogenism revisited. Endocr Rev. 2016;37:467-520. doi: 10.1210/er.2015-1104.
  3. Zhu JL, Chen Z, Feng WJ, et al. Sex hormone-binding globulin and polycystic ovary syndrome. Clin Chim Acta. 2019;499:142-148. doi: 10.1016/j.cca.2019.09.010.
  4. Oner G, Muderris II. A prospective randomized trial comparing low-dose ethinyl estradiol and drospirenone 24/4 combined oral contraceptive vs. ethinyl estradiol and drospirenone 21/7 combined oral contraceptive in the treatment of hirsutism. Contraception. 2011;84:508-511. doi: 10.1016/j.contraception.2011.03.002.
  5. Boyd RA, Zegarac EA, Posvar EL, et al. Minimal androgenic activity of a new oral contraceptive containing norethindrone acetate and graduated doses of ethinyl estradiol. Contraception. 2001;63:71-76. doi: 10.1016/s0010-7824(01)00179-2.
  6. Thorneycroft IH, Stanczyk FZ, Bradshaw KD, et al. Effect of low-dose oral contraceptives on androgenic markers and acne. Contraception. 1999;60:255-262. doi: 10.1016/s0010-7824(99)00093-1.
  7. Kaser DJ, Missmer SA, Berry KF, et al. Use of norethindrone acetate alone for postoperative suppression of endometriosis symptoms. J Pediatr Adolesc Gynecol. 2012;25:105-108. doi: 10.1016/j.jpag.2011.09.013.
  8. Aygestin [package insert]. Pomona, NY: Duramed Pharmaceuticals; 2007.
  9. Camila [package insert]. Greenville, NC; Mayne Pharma; 2018.
  10. Santoro N, Brown JR, Adel T, et al. Characterization of reproductive hormonal dynamics in the perimenopause. J Clin Endocrinol Metab. 1996;81:1495-1501. doi: 10.1210/jcem.81.4.8636357.
  11. Speroff L, Symons J, Kempfert N, et al; FemHrt Study Investigators. The effect of varying low-dose combinations of norethindrone acetate and ethinyl estradiol (Femhrt) on the frequency and intensity of vasomotor symptoms. Menopause. 2000;7:383-390. doi: 10.1097/00042192-200011000-00003.
Article PDF
Author and Disclosure Information

Robert L. Barbieri, MD

Chair Emeritus, Department of Obstetrics and Gynecology
Interim Chief, Obstetrics
Brigham and Women’s Hospital
Kate Macy Ladd Distinguished Professor of Obstetrics,
 Gynecology and Reproductive Biology
Harvard Medical School
Boston, Massachusetts

Dr. Barbieri reports no financial relationships relevant to this article.

Issue
OBG Management - 33(7)
Publications
Topics
Page Number
9, 13-14
Sections
Author and Disclosure Information

Robert L. Barbieri, MD

Chair Emeritus, Department of Obstetrics and Gynecology
Interim Chief, Obstetrics
Brigham and Women’s Hospital
Kate Macy Ladd Distinguished Professor of Obstetrics,
 Gynecology and Reproductive Biology
Harvard Medical School
Boston, Massachusetts

Dr. Barbieri reports no financial relationships relevant to this article.

Author and Disclosure Information

Robert L. Barbieri, MD

Chair Emeritus, Department of Obstetrics and Gynecology
Interim Chief, Obstetrics
Brigham and Women’s Hospital
Kate Macy Ladd Distinguished Professor of Obstetrics,
 Gynecology and Reproductive Biology
Harvard Medical School
Boston, Massachusetts

Dr. Barbieri reports no financial relationships relevant to this article.

Article PDF
Article PDF

There are dozens of medications containing combinations of estrogen and progestin. I am often confused by the bewildering proliferation of generic brand names used to describe the same estrogen-progestin (E-P) regimen. For example, the combination medication containing ethinyl estradiol 20 µg plus norethindrone acetate (NEA) 1 mg is available under at least 5 different names: Lo Estrin 1/20 (Warner Chilcot), Junel 1/20 (Teva Pharmaceuticals), Microgestin Fe 1/20 (Mayne Pharma), Gildess 1/20 (Qualitest Pharmaceuticals), and Larin 1/20 (Novast Laboratories). To reduce the confusion, it is often useful to select a single preferred estrogen and progestin and use the dose combinations that are available to treat a wide range of gynecology problems (TABLE). In this editorial I focus on using various dose combinations of ethinyl estradiol and NEA to treat 3 common gynecologic problems.

CASE 1 Polycystic ovary syndrome

A 19-year-old woman reports 4 spontaneous menses in the past year and bothersome facial hair and acne. Her total testosterone concentration is at the upper limit of normal (0.46 ng/mL) and her sex hormone binding globulin (SHBG) concentration is at the lower limit of normal (35 nM). For treatment of the patient’s menstrual disorder, what is an optimal E-P combination?

Prioritize the use of an estrogen-dominant medication

Based on the Rotterdam criteria this woman has polycystic ovary syndrome (PCOS).1 In women with PCOS, luteinizing hormone (LH) secretion is increased, stimulating excessive ovarian production of testosterone.2 In addition, many women with PCOS have decreased hepatic secretion of SHBG, a binding protein that prevents testosterone from entering cells, resulting in excessive bioavailable testosterone.3 The Endocrine Society recommends that women with PCOS who have menstrual dysfunction or hirsutism be treated initially with a combination E-P hormone medication.1 Combination E-P medications suppress pituitary secretion of LH, thereby reducing ovarian production of testosterone, and ethinyl estradiol increases hepatic secretion of SHBG, reducing bioavailable testosterone. These two goals are best accomplished with an oral E-P hormone medication containing ethinyl estradiol doses of 20 µg to 30 µg per pill. An E-P hormone medication containing pills with an ethinyl estradiol dose ≤ 10 µg-daily may stimulate less hepatic production of SHBG than a pill with an ethinyl estradiol dose of 20 µg or 30 µg daily.4,5 In addition, E-P pills containing levonorgestrel suppress SHBG hormone secretion compared with E-P pills with other progestins.6 Therefore, levonorgestrel-containing E-P pills should not be prioritized for use in women with PCOS because the estrogen-induced increase in SHBG will be blunted by levonorgestrel.

CASE 2 Moderate to severe pelvic pain caused by endometriosis

A 25-year-old woman (G0) with severe dysmenorrhea had a laparoscopy showing endometriosis lesions in the cul-de-sac and a peritoneal window near the left uterosacral ligament. Biopsy showed endometriosis. Postoperatively, the patient was treated with an E-P pill containing 30 µg ethinyl estradiol and 0.15 mg desogestrel per pill using a continuous-dosing protocol. During the year following the laparoscopy, her pelvic pain symptoms gradually increased until they became severe, preventing her from performing daily activities on multiple days per month. She was prescribed elagolix but her insurance did not approve the treatment. What alternative treatment would you prescribe?

Continue to: Use progestin-dominant pills to treat pelvic pain...

 

 

Use progestin-dominant pills to treat pelvic pain

Cellular activity in endometriosis lesions is stimulated by estradiol and inhibited by a high concentration of androgenic progestins or androgens. This simplified endocrine paradigm explains the effectiveness of hormonal treatments that suppress ovarian estradiol production, including leuprolide, elagolix, medroxyprogesterone acetate, and NEA. For the woman in the above case, I would advocate for elagolix treatment but, following the insurance denial of the prescription, an alternative treatment for moderate or severe pelvic pain caused by endometriosis would be a progestin-dominant hormone medication (for example, NEA 5 mg daily). Norethindrone acetate 5 mg daily may be associated with bothersome adverse effects including weight gain (16% of patients; mean weight gain, 3.1 kg), acne (10%), mood lability (9%), hot flashes (8%), depression (6%), scalp hair loss (4%), headache (4%), nausea (3%), and deepening of the voice (1%).7

I sometimes see women with moderate to severe pelvic pain caused by endometriosis being treated with norethindrone 0.35 mg daily. This dose of norethindrone is suboptimal for pain treatment because it does not reliably suppress ovarian production of estradiol. In addition, the cells in endometriosis lesions are often resistant to the effects of progesterone, requiring higher dosages to produce secretory or decidual changes. In most situations, I recommend against the use of norethindrone 0.35 mg daily for the treatment of pelvic pain caused by endometriosis.

Patients commonly ask if NEA 5 mg daily has contraceptive efficacy. Although it is not approved at this dosage by the US Food and Drug Administration as a contraceptive,8 norethindrone 0.35 mg daily is approved as a progestin-only contraceptive.9 Norethindrone acetate is rapidly and completely deacetylated to norethindrone and the disposition of oral NEA is indistinguishable from that of norethindrone (which is the FDA-approved dosage mentioned above). Since norethindrone 0.35 mg daily is approved as a contraceptive, it is highly likely that NEA 5 mg daily has contraceptive efficacy, especially if there is good adherence with the daily medication.

CASE 3 Perimenopausal AUB

A 45-year-old woman reports varying menstrual cycle lengths from 24 to 60 days with very heavy menses in some cycles. Pelvic ultrasonography shows no abnormality. Endometrial biopsy shows a proliferative endometrium. Her serum progesterone level, obtained 1 week before the onset of menses, is < 3 ng/mL. She has no past history of heavy menses, easy bruising, excessive bleeding with procedures, or a family history of bleeding problems. She also reports occasional hot flashes that wake her from sleep.

Use an estrogen step-down regimen to manage postmenopause transition

This patient is likely in the perimenopause transition, and the abnormal uterine bleeding (AUB) is caused, in part, by oligo- or anovulation. Perimenopausal women with AUB may have cycles characterized by above normal ovarian estradiol production and below normal progesterone production, or frank anovulation.10 Elevated ovarian estrogen and low progesterone production sets the stage for heavy bleeding in the perimenopause, regardless of the presence of uterine pathology such as fibroids.

For perimenopausal women, one option for treatment of AUB due to anovulation is to prescribe an estrogen step-down regimen. For the 45-year-old woman in this case, initiating treatment with an E-P pill containing ethinyl estradiol 10 µg and NEA 1 mg will likely control the AUB and her occasional hot flash.11 As the woman ages, the ethinyl estradiol dose can be decreased to pills containing 5 µg and then 2.5 µg, covering the transition into postmenopause. Once the woman is in the postmenopause, treatment with transdermal estradiol and oral micronized progesterone is an option to treat menopausal vasomotor symptoms.

 

Optimize estrogen and progestin treatment for your patients

Many gynecologic problems are effectively treated by estrogen and/or progestin steroids. The dose of estrogen and progestin should be tailored to the specific problem. For PCOS, the estrogen dose selected should be sufficient to safely stimulate hepatic SHBG production. For endometriosis, if a GnRH antagonist is not available to the patient, a high-dose progestin, such as NEA 5 mg, may be an effective treatment. During the perimenopause transition in a woman with AUB, a treatment plan using a sequential E-P step-down program might control symptoms and help smoothly glide the patient into the postmenopause. ●

There are dozens of medications containing combinations of estrogen and progestin. I am often confused by the bewildering proliferation of generic brand names used to describe the same estrogen-progestin (E-P) regimen. For example, the combination medication containing ethinyl estradiol 20 µg plus norethindrone acetate (NEA) 1 mg is available under at least 5 different names: Lo Estrin 1/20 (Warner Chilcot), Junel 1/20 (Teva Pharmaceuticals), Microgestin Fe 1/20 (Mayne Pharma), Gildess 1/20 (Qualitest Pharmaceuticals), and Larin 1/20 (Novast Laboratories). To reduce the confusion, it is often useful to select a single preferred estrogen and progestin and use the dose combinations that are available to treat a wide range of gynecology problems (TABLE). In this editorial I focus on using various dose combinations of ethinyl estradiol and NEA to treat 3 common gynecologic problems.

CASE 1 Polycystic ovary syndrome

A 19-year-old woman reports 4 spontaneous menses in the past year and bothersome facial hair and acne. Her total testosterone concentration is at the upper limit of normal (0.46 ng/mL) and her sex hormone binding globulin (SHBG) concentration is at the lower limit of normal (35 nM). For treatment of the patient’s menstrual disorder, what is an optimal E-P combination?

Prioritize the use of an estrogen-dominant medication

Based on the Rotterdam criteria this woman has polycystic ovary syndrome (PCOS).1 In women with PCOS, luteinizing hormone (LH) secretion is increased, stimulating excessive ovarian production of testosterone.2 In addition, many women with PCOS have decreased hepatic secretion of SHBG, a binding protein that prevents testosterone from entering cells, resulting in excessive bioavailable testosterone.3 The Endocrine Society recommends that women with PCOS who have menstrual dysfunction or hirsutism be treated initially with a combination E-P hormone medication.1 Combination E-P medications suppress pituitary secretion of LH, thereby reducing ovarian production of testosterone, and ethinyl estradiol increases hepatic secretion of SHBG, reducing bioavailable testosterone. These two goals are best accomplished with an oral E-P hormone medication containing ethinyl estradiol doses of 20 µg to 30 µg per pill. An E-P hormone medication containing pills with an ethinyl estradiol dose ≤ 10 µg-daily may stimulate less hepatic production of SHBG than a pill with an ethinyl estradiol dose of 20 µg or 30 µg daily.4,5 In addition, E-P pills containing levonorgestrel suppress SHBG hormone secretion compared with E-P pills with other progestins.6 Therefore, levonorgestrel-containing E-P pills should not be prioritized for use in women with PCOS because the estrogen-induced increase in SHBG will be blunted by levonorgestrel.

CASE 2 Moderate to severe pelvic pain caused by endometriosis

A 25-year-old woman (G0) with severe dysmenorrhea had a laparoscopy showing endometriosis lesions in the cul-de-sac and a peritoneal window near the left uterosacral ligament. Biopsy showed endometriosis. Postoperatively, the patient was treated with an E-P pill containing 30 µg ethinyl estradiol and 0.15 mg desogestrel per pill using a continuous-dosing protocol. During the year following the laparoscopy, her pelvic pain symptoms gradually increased until they became severe, preventing her from performing daily activities on multiple days per month. She was prescribed elagolix but her insurance did not approve the treatment. What alternative treatment would you prescribe?

Continue to: Use progestin-dominant pills to treat pelvic pain...

 

 

Use progestin-dominant pills to treat pelvic pain

Cellular activity in endometriosis lesions is stimulated by estradiol and inhibited by a high concentration of androgenic progestins or androgens. This simplified endocrine paradigm explains the effectiveness of hormonal treatments that suppress ovarian estradiol production, including leuprolide, elagolix, medroxyprogesterone acetate, and NEA. For the woman in the above case, I would advocate for elagolix treatment but, following the insurance denial of the prescription, an alternative treatment for moderate or severe pelvic pain caused by endometriosis would be a progestin-dominant hormone medication (for example, NEA 5 mg daily). Norethindrone acetate 5 mg daily may be associated with bothersome adverse effects including weight gain (16% of patients; mean weight gain, 3.1 kg), acne (10%), mood lability (9%), hot flashes (8%), depression (6%), scalp hair loss (4%), headache (4%), nausea (3%), and deepening of the voice (1%).7

I sometimes see women with moderate to severe pelvic pain caused by endometriosis being treated with norethindrone 0.35 mg daily. This dose of norethindrone is suboptimal for pain treatment because it does not reliably suppress ovarian production of estradiol. In addition, the cells in endometriosis lesions are often resistant to the effects of progesterone, requiring higher dosages to produce secretory or decidual changes. In most situations, I recommend against the use of norethindrone 0.35 mg daily for the treatment of pelvic pain caused by endometriosis.

Patients commonly ask if NEA 5 mg daily has contraceptive efficacy. Although it is not approved at this dosage by the US Food and Drug Administration as a contraceptive,8 norethindrone 0.35 mg daily is approved as a progestin-only contraceptive.9 Norethindrone acetate is rapidly and completely deacetylated to norethindrone and the disposition of oral NEA is indistinguishable from that of norethindrone (which is the FDA-approved dosage mentioned above). Since norethindrone 0.35 mg daily is approved as a contraceptive, it is highly likely that NEA 5 mg daily has contraceptive efficacy, especially if there is good adherence with the daily medication.

CASE 3 Perimenopausal AUB

A 45-year-old woman reports varying menstrual cycle lengths from 24 to 60 days with very heavy menses in some cycles. Pelvic ultrasonography shows no abnormality. Endometrial biopsy shows a proliferative endometrium. Her serum progesterone level, obtained 1 week before the onset of menses, is < 3 ng/mL. She has no past history of heavy menses, easy bruising, excessive bleeding with procedures, or a family history of bleeding problems. She also reports occasional hot flashes that wake her from sleep.

Use an estrogen step-down regimen to manage postmenopause transition

This patient is likely in the perimenopause transition, and the abnormal uterine bleeding (AUB) is caused, in part, by oligo- or anovulation. Perimenopausal women with AUB may have cycles characterized by above normal ovarian estradiol production and below normal progesterone production, or frank anovulation.10 Elevated ovarian estrogen and low progesterone production sets the stage for heavy bleeding in the perimenopause, regardless of the presence of uterine pathology such as fibroids.

For perimenopausal women, one option for treatment of AUB due to anovulation is to prescribe an estrogen step-down regimen. For the 45-year-old woman in this case, initiating treatment with an E-P pill containing ethinyl estradiol 10 µg and NEA 1 mg will likely control the AUB and her occasional hot flash.11 As the woman ages, the ethinyl estradiol dose can be decreased to pills containing 5 µg and then 2.5 µg, covering the transition into postmenopause. Once the woman is in the postmenopause, treatment with transdermal estradiol and oral micronized progesterone is an option to treat menopausal vasomotor symptoms.

 

Optimize estrogen and progestin treatment for your patients

Many gynecologic problems are effectively treated by estrogen and/or progestin steroids. The dose of estrogen and progestin should be tailored to the specific problem. For PCOS, the estrogen dose selected should be sufficient to safely stimulate hepatic SHBG production. For endometriosis, if a GnRH antagonist is not available to the patient, a high-dose progestin, such as NEA 5 mg, may be an effective treatment. During the perimenopause transition in a woman with AUB, a treatment plan using a sequential E-P step-down program might control symptoms and help smoothly glide the patient into the postmenopause. ●

References
  1. Legro RS, Arslanian SA, Ehrmann DA, et al. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98:4565-4592. doi: 10.1210/jc.2013-2350.
  2. Rosenfield RL, Ehrmann DA. The pathogenesis of polycystic ovary syndrome (PCOS): the hypothesis of PCOS as functional ovarian hyperandrogenism revisited. Endocr Rev. 2016;37:467-520. doi: 10.1210/er.2015-1104.
  3. Zhu JL, Chen Z, Feng WJ, et al. Sex hormone-binding globulin and polycystic ovary syndrome. Clin Chim Acta. 2019;499:142-148. doi: 10.1016/j.cca.2019.09.010.
  4. Oner G, Muderris II. A prospective randomized trial comparing low-dose ethinyl estradiol and drospirenone 24/4 combined oral contraceptive vs. ethinyl estradiol and drospirenone 21/7 combined oral contraceptive in the treatment of hirsutism. Contraception. 2011;84:508-511. doi: 10.1016/j.contraception.2011.03.002.
  5. Boyd RA, Zegarac EA, Posvar EL, et al. Minimal androgenic activity of a new oral contraceptive containing norethindrone acetate and graduated doses of ethinyl estradiol. Contraception. 2001;63:71-76. doi: 10.1016/s0010-7824(01)00179-2.
  6. Thorneycroft IH, Stanczyk FZ, Bradshaw KD, et al. Effect of low-dose oral contraceptives on androgenic markers and acne. Contraception. 1999;60:255-262. doi: 10.1016/s0010-7824(99)00093-1.
  7. Kaser DJ, Missmer SA, Berry KF, et al. Use of norethindrone acetate alone for postoperative suppression of endometriosis symptoms. J Pediatr Adolesc Gynecol. 2012;25:105-108. doi: 10.1016/j.jpag.2011.09.013.
  8. Aygestin [package insert]. Pomona, NY: Duramed Pharmaceuticals; 2007.
  9. Camila [package insert]. Greenville, NC; Mayne Pharma; 2018.
  10. Santoro N, Brown JR, Adel T, et al. Characterization of reproductive hormonal dynamics in the perimenopause. J Clin Endocrinol Metab. 1996;81:1495-1501. doi: 10.1210/jcem.81.4.8636357.
  11. Speroff L, Symons J, Kempfert N, et al; FemHrt Study Investigators. The effect of varying low-dose combinations of norethindrone acetate and ethinyl estradiol (Femhrt) on the frequency and intensity of vasomotor symptoms. Menopause. 2000;7:383-390. doi: 10.1097/00042192-200011000-00003.
References
  1. Legro RS, Arslanian SA, Ehrmann DA, et al. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013;98:4565-4592. doi: 10.1210/jc.2013-2350.
  2. Rosenfield RL, Ehrmann DA. The pathogenesis of polycystic ovary syndrome (PCOS): the hypothesis of PCOS as functional ovarian hyperandrogenism revisited. Endocr Rev. 2016;37:467-520. doi: 10.1210/er.2015-1104.
  3. Zhu JL, Chen Z, Feng WJ, et al. Sex hormone-binding globulin and polycystic ovary syndrome. Clin Chim Acta. 2019;499:142-148. doi: 10.1016/j.cca.2019.09.010.
  4. Oner G, Muderris II. A prospective randomized trial comparing low-dose ethinyl estradiol and drospirenone 24/4 combined oral contraceptive vs. ethinyl estradiol and drospirenone 21/7 combined oral contraceptive in the treatment of hirsutism. Contraception. 2011;84:508-511. doi: 10.1016/j.contraception.2011.03.002.
  5. Boyd RA, Zegarac EA, Posvar EL, et al. Minimal androgenic activity of a new oral contraceptive containing norethindrone acetate and graduated doses of ethinyl estradiol. Contraception. 2001;63:71-76. doi: 10.1016/s0010-7824(01)00179-2.
  6. Thorneycroft IH, Stanczyk FZ, Bradshaw KD, et al. Effect of low-dose oral contraceptives on androgenic markers and acne. Contraception. 1999;60:255-262. doi: 10.1016/s0010-7824(99)00093-1.
  7. Kaser DJ, Missmer SA, Berry KF, et al. Use of norethindrone acetate alone for postoperative suppression of endometriosis symptoms. J Pediatr Adolesc Gynecol. 2012;25:105-108. doi: 10.1016/j.jpag.2011.09.013.
  8. Aygestin [package insert]. Pomona, NY: Duramed Pharmaceuticals; 2007.
  9. Camila [package insert]. Greenville, NC; Mayne Pharma; 2018.
  10. Santoro N, Brown JR, Adel T, et al. Characterization of reproductive hormonal dynamics in the perimenopause. J Clin Endocrinol Metab. 1996;81:1495-1501. doi: 10.1210/jcem.81.4.8636357.
  11. Speroff L, Symons J, Kempfert N, et al; FemHrt Study Investigators. The effect of varying low-dose combinations of norethindrone acetate and ethinyl estradiol (Femhrt) on the frequency and intensity of vasomotor symptoms. Menopause. 2000;7:383-390. doi: 10.1097/00042192-200011000-00003.
Issue
OBG Management - 33(7)
Issue
OBG Management - 33(7)
Page Number
9, 13-14
Page Number
9, 13-14
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media