Gynecology

Travel distance is an important determinant of access to abortion care in the United States, new findings show.

Increases in median travel distance to the nearest abortion care facility were associated with significant reductions in median abortion rate.

The abortion rate was 21.1 per 1,000 female residents of reproductive age among those who lived less than 5 miles from a facility, but that number dropped to 3.9/1,000 for those living 120 miles or further away.

Overall, in a model of 3,107 U.S. counties that included 62.5 million women of reproductive age, there were an estimated 696,760 abortions (at a mean rate of 11.1/1,000). The authors estimate that if abortion services were integrated into primary care, an additional 18,190 abortions would be performed (mean rate, 11.4/1,000).

Similarly, if telemedicine became widely available in this setting, this would allow approximately 70,920 abortions (mean rate 12.3/1,000). The study was published online in JAMA Open Network.

Reducing travel distances to abortion facilities would increase access, but additional clinics and providers would be needed to meet the demand. But as the population density of many counties with poor access is low, innovative strategies are also needed.

Integrating abortion into primary care or making medication abortion care available by telemedicine may decrease this unmet need, and lead author Kirsten Thompson, MPH, noted that there is growing evidence that both solutions are quite feasible to implement.

“A study published in 2018 has led primary care providers to adopt the same regimen for miscarriage care, showing that they are interested and capable, despite the barriers posed by the mifepristone [Risk Evaluation and Mitigation Strategy] program for these patients,” said Ms. Thompson, who is program and communications director, Bixby Center for Global Reproductive Health, University of California, San Francisco. “Medical education programs designed specifically for primary care providers have trained family medicine and other clinicians in abortion care for over a decade.”

As for telemedicine, Ms. Thompson explained that, during the pandemic, a preliminary injunction in a federal court case and then the Food and Drug Administration suspended enforcement of the in-person requirements of the mifepristone REMS. “In states that allow medical abortion care by telemedicine, providers have been able to offer remote care when medically appropriate, including mailing medical abortion pills to patients at home,” she said. “Researchers have already published evidence on the safety of and patient satisfaction with this approach.”

However, there are two main barriers to the widespread adoption of medical abortion by telemedicine in the United States. “One is the potentially temporary nature of the FDA’s enforcement discretion and second, are the 19 states with laws that ban it, singling out medical abortion as somehow different from other forms of care by telemedicine,” she said.
 

Study details

About one in four women in the United States will terminate a pregnancy during their lifetime, but the issue is highly contentious and many states have implemented policies that restrict access to abortion care. The authors pointed out that studies have documented clinic closures and women being unable to obtain abortion care, with low-income women and non-White women being disproportionately affected. Increased travel to a provider has also been associated with delays in care as well as increased costs and stress.

Prior research has shown that the further a woman lives from a facility, the less likely she is to obtain abortion care. In this study, Ms. Thompson and colleagues examined the association between travel distance to the nearest abortion care facility and the abortion rate, and then modeled the effect of reduced travel distance on rates.

They first conducted a cross-sectional geographic analysis using the American Community Survey and the U.S. Census to calculate county-level abortion rates per 1,000 women aged between 15 and 44 years. The 2015 data covered 1,948 counties in 27 states.

Abortion rates were then estimated for 3,107 counties in 48 states and the effect of different travel distance scenarios on the abortion rate was also estimated by multivariable model. Data were collected from April 2018 to October 2019.

There were 37.3 million women of reproductive age residing in the 27 states, and a total of 428,720 reported abortions (mean rate, 11.5/1,000; median rate, 9.9/1,000 women).

When looking at all 48 states, the population-weighted mean travel distance to the nearest facility was 25.6 miles, with a median travel distance of 8.2 miles.

A multivariable model showed that a greater travel distance was associated with lower abortion rates. When compared with traveling less than 5 miles, the abortion rate declined by 0.05/1,000 for women traveling between 5 to less than 15 miles for care, 0.22 for those traveling 15 to less than 30 miles, 0.34 for 30 to less than 60 miles, 0.43 for 60 to less than 120 miles, and 0.73 for those traveling 120 miles or more.

They estimated that, if all travel was under 30 miles, there would be a 2.6% increase or 18,190 additional abortions. A simulation also showed that there would be a 10.2% increase (70,920 additional abortions) using medication via telemedicine.
 

Solutions are feasible

Approached for an independent comment, Sarah W. Prager, MD, MAS, professor of obstetrics and gynecology and division chief, complex family planning, at the University of Washington, Seattle, agreed that the solutions proposed by the authors were feasible.

“More than a third of abortions that are eligible are now done with medication,” she said, “And 89% of abortions are done in the first trimester.”

What this means is that early first-trimester abortions can conceivably be performed in the primary care setting. “Any primary care clinician – whether it’s a family practice or internal medicine physician, or nurse practitioner or nurse midwife – can all be trained to do aspiration or prescribe medication in the first trimester,” said Dr. Prager. “So it could easily be integrated into primary care settings if there was motivation for that to happen.”

However, she emphasized that more is involved than just training the provider. “The whole clinic has to buy into it,” Dr. Prager explained. “The nurses have to be willing to assist, you need the medical assistants, the scheduler or person who works the front desk – the whole clinic system has to buy into it and that’s where it becomes more challenging.”

The individual provider may be willing, but the system may still not be allowing that to happen. “This is also where telemedicine can come in, where the medication can be mailed so it can circumvent the problem to a certain extent,” Dr. Prager added. “You don’t have to have the infrastructure in the same way.”

But many states already have laws in place to make that illegal, especially for abortion care even if they allow it for similar types of care.

Another expert also weighed in and agreed that these two solutions can potentially be implemented.

“The concept of decreased rates of abortion associated with greater distances traveled is not new, but what is unique to this manuscript is the estimations that the authors conducted in understanding the impact of expanding access to abortion among primary care and telehealth providers,” said Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology, University of California, Davis.

“The study provides convincing evidence regarding the need to strengthen infrastructures that support expansion of these services in primary care settings, among physicians and advanced care practitioners,” she said. “Training to provide medical abortion and first-trimester surgical abortion is simple. Many primary care providers are already doing gynecologic procedures – IUD insertions, colposcopies, endometrial biopsies.”

Thus, she noted, adding abortion care “to their toolkit isn’t too far of a stretch.”

As for telemedicine, Dr. Cansino pointed out how the COVID-19 pandemic has also expanded what both patients and providers think are safe options for providing and receiving good care. “Consultations through telemedicine coupled with access to medications for medical abortion through local pharmacies or express mail is definitely safe and feasible.”

The study was supported by the William and Flora Hewlett Foundation and by an anonymous foundation for general operating support (Ms Thompson). Ms. Thompson reported receiving personal fees from GenBioPro outside the submitted work. Dr. Cansino and Dr. Prager have no disclosures.

Travel distance is an important determinant of access to abortion care in the United States, new findings show.

Increases in median travel distance to the nearest abortion care facility were associated with significant reductions in median abortion rate.

The abortion rate was 21.1 per 1,000 female residents of reproductive age among those who lived less than 5 miles from a facility, but that number dropped to 3.9/1,000 for those living 120 miles or further away.

Overall, in a model of 3,107 U.S. counties that included 62.5 million women of reproductive age, there were an estimated 696,760 abortions (at a mean rate of 11.1/1,000). The authors estimate that if abortion services were integrated into primary care, an additional 18,190 abortions would be performed (mean rate, 11.4/1,000).

Similarly, if telemedicine became widely available in this setting, this would allow approximately 70,920 abortions (mean rate 12.3/1,000). The study was published online in JAMA Open Network.

Reducing travel distances to abortion facilities would increase access, but additional clinics and providers would be needed to meet the demand. But as the population density of many counties with poor access is low, innovative strategies are also needed.

Integrating abortion into primary care or making medication abortion care available by telemedicine may decrease this unmet need, and lead author Kirsten Thompson, MPH, noted that there is growing evidence that both solutions are quite feasible to implement.

“A study published in 2018 has led primary care providers to adopt the same regimen for miscarriage care, showing that they are interested and capable, despite the barriers posed by the mifepristone [Risk Evaluation and Mitigation Strategy] program for these patients,” said Ms. Thompson, who is program and communications director, Bixby Center for Global Reproductive Health, University of California, San Francisco. “Medical education programs designed specifically for primary care providers have trained family medicine and other clinicians in abortion care for over a decade.”

As for telemedicine, Ms. Thompson explained that, during the pandemic, a preliminary injunction in a federal court case and then the Food and Drug Administration suspended enforcement of the in-person requirements of the mifepristone REMS. “In states that allow medical abortion care by telemedicine, providers have been able to offer remote care when medically appropriate, including mailing medical abortion pills to patients at home,” she said. “Researchers have already published evidence on the safety of and patient satisfaction with this approach.”

However, there are two main barriers to the widespread adoption of medical abortion by telemedicine in the United States. “One is the potentially temporary nature of the FDA’s enforcement discretion and second, are the 19 states with laws that ban it, singling out medical abortion as somehow different from other forms of care by telemedicine,” she said.
 

Study details

About one in four women in the United States will terminate a pregnancy during their lifetime, but the issue is highly contentious and many states have implemented policies that restrict access to abortion care. The authors pointed out that studies have documented clinic closures and women being unable to obtain abortion care, with low-income women and non-White women being disproportionately affected. Increased travel to a provider has also been associated with delays in care as well as increased costs and stress.

Prior research has shown that the further a woman lives from a facility, the less likely she is to obtain abortion care. In this study, Ms. Thompson and colleagues examined the association between travel distance to the nearest abortion care facility and the abortion rate, and then modeled the effect of reduced travel distance on rates.

They first conducted a cross-sectional geographic analysis using the American Community Survey and the U.S. Census to calculate county-level abortion rates per 1,000 women aged between 15 and 44 years. The 2015 data covered 1,948 counties in 27 states.

Abortion rates were then estimated for 3,107 counties in 48 states and the effect of different travel distance scenarios on the abortion rate was also estimated by multivariable model. Data were collected from April 2018 to October 2019.

There were 37.3 million women of reproductive age residing in the 27 states, and a total of 428,720 reported abortions (mean rate, 11.5/1,000; median rate, 9.9/1,000 women).

When looking at all 48 states, the population-weighted mean travel distance to the nearest facility was 25.6 miles, with a median travel distance of 8.2 miles.

A multivariable model showed that a greater travel distance was associated with lower abortion rates. When compared with traveling less than 5 miles, the abortion rate declined by 0.05/1,000 for women traveling between 5 to less than 15 miles for care, 0.22 for those traveling 15 to less than 30 miles, 0.34 for 30 to less than 60 miles, 0.43 for 60 to less than 120 miles, and 0.73 for those traveling 120 miles or more.

They estimated that, if all travel was under 30 miles, there would be a 2.6% increase or 18,190 additional abortions. A simulation also showed that there would be a 10.2% increase (70,920 additional abortions) using medication via telemedicine.
 

Solutions are feasible

Approached for an independent comment, Sarah W. Prager, MD, MAS, professor of obstetrics and gynecology and division chief, complex family planning, at the University of Washington, Seattle, agreed that the solutions proposed by the authors were feasible.

“More than a third of abortions that are eligible are now done with medication,” she said, “And 89% of abortions are done in the first trimester.”

What this means is that early first-trimester abortions can conceivably be performed in the primary care setting. “Any primary care clinician – whether it’s a family practice or internal medicine physician, or nurse practitioner or nurse midwife – can all be trained to do aspiration or prescribe medication in the first trimester,” said Dr. Prager. “So it could easily be integrated into primary care settings if there was motivation for that to happen.”

However, she emphasized that more is involved than just training the provider. “The whole clinic has to buy into it,” Dr. Prager explained. “The nurses have to be willing to assist, you need the medical assistants, the scheduler or person who works the front desk – the whole clinic system has to buy into it and that’s where it becomes more challenging.”

The individual provider may be willing, but the system may still not be allowing that to happen. “This is also where telemedicine can come in, where the medication can be mailed so it can circumvent the problem to a certain extent,” Dr. Prager added. “You don’t have to have the infrastructure in the same way.”

But many states already have laws in place to make that illegal, especially for abortion care even if they allow it for similar types of care.

Another expert also weighed in and agreed that these two solutions can potentially be implemented.

“The concept of decreased rates of abortion associated with greater distances traveled is not new, but what is unique to this manuscript is the estimations that the authors conducted in understanding the impact of expanding access to abortion among primary care and telehealth providers,” said Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology, University of California, Davis.

“The study provides convincing evidence regarding the need to strengthen infrastructures that support expansion of these services in primary care settings, among physicians and advanced care practitioners,” she said. “Training to provide medical abortion and first-trimester surgical abortion is simple. Many primary care providers are already doing gynecologic procedures – IUD insertions, colposcopies, endometrial biopsies.”

Thus, she noted, adding abortion care “to their toolkit isn’t too far of a stretch.”

As for telemedicine, Dr. Cansino pointed out how the COVID-19 pandemic has also expanded what both patients and providers think are safe options for providing and receiving good care. “Consultations through telemedicine coupled with access to medications for medical abortion through local pharmacies or express mail is definitely safe and feasible.”

The study was supported by the William and Flora Hewlett Foundation and by an anonymous foundation for general operating support (Ms Thompson). Ms. Thompson reported receiving personal fees from GenBioPro outside the submitted work. Dr. Cansino and Dr. Prager have no disclosures.

Travel distance is an important determinant of access to abortion care in the United States, new findings show.

Increases in median travel distance to the nearest abortion care facility were associated with significant reductions in median abortion rate.

The abortion rate was 21.1 per 1,000 female residents of reproductive age among those who lived less than 5 miles from a facility, but that number dropped to 3.9/1,000 for those living 120 miles or further away.

Overall, in a model of 3,107 U.S. counties that included 62.5 million women of reproductive age, there were an estimated 696,760 abortions (at a mean rate of 11.1/1,000). The authors estimate that if abortion services were integrated into primary care, an additional 18,190 abortions would be performed (mean rate, 11.4/1,000).

Similarly, if telemedicine became widely available in this setting, this would allow approximately 70,920 abortions (mean rate 12.3/1,000). The study was published online in JAMA Open Network.

Reducing travel distances to abortion facilities would increase access, but additional clinics and providers would be needed to meet the demand. But as the population density of many counties with poor access is low, innovative strategies are also needed.

Integrating abortion into primary care or making medication abortion care available by telemedicine may decrease this unmet need, and lead author Kirsten Thompson, MPH, noted that there is growing evidence that both solutions are quite feasible to implement.

“A study published in 2018 has led primary care providers to adopt the same regimen for miscarriage care, showing that they are interested and capable, despite the barriers posed by the mifepristone [Risk Evaluation and Mitigation Strategy] program for these patients,” said Ms. Thompson, who is program and communications director, Bixby Center for Global Reproductive Health, University of California, San Francisco. “Medical education programs designed specifically for primary care providers have trained family medicine and other clinicians in abortion care for over a decade.”

As for telemedicine, Ms. Thompson explained that, during the pandemic, a preliminary injunction in a federal court case and then the Food and Drug Administration suspended enforcement of the in-person requirements of the mifepristone REMS. “In states that allow medical abortion care by telemedicine, providers have been able to offer remote care when medically appropriate, including mailing medical abortion pills to patients at home,” she said. “Researchers have already published evidence on the safety of and patient satisfaction with this approach.”

However, there are two main barriers to the widespread adoption of medical abortion by telemedicine in the United States. “One is the potentially temporary nature of the FDA’s enforcement discretion and second, are the 19 states with laws that ban it, singling out medical abortion as somehow different from other forms of care by telemedicine,” she said.
 

Study details

About one in four women in the United States will terminate a pregnancy during their lifetime, but the issue is highly contentious and many states have implemented policies that restrict access to abortion care. The authors pointed out that studies have documented clinic closures and women being unable to obtain abortion care, with low-income women and non-White women being disproportionately affected. Increased travel to a provider has also been associated with delays in care as well as increased costs and stress.

Prior research has shown that the further a woman lives from a facility, the less likely she is to obtain abortion care. In this study, Ms. Thompson and colleagues examined the association between travel distance to the nearest abortion care facility and the abortion rate, and then modeled the effect of reduced travel distance on rates.

They first conducted a cross-sectional geographic analysis using the American Community Survey and the U.S. Census to calculate county-level abortion rates per 1,000 women aged between 15 and 44 years. The 2015 data covered 1,948 counties in 27 states.

Abortion rates were then estimated for 3,107 counties in 48 states and the effect of different travel distance scenarios on the abortion rate was also estimated by multivariable model. Data were collected from April 2018 to October 2019.

There were 37.3 million women of reproductive age residing in the 27 states, and a total of 428,720 reported abortions (mean rate, 11.5/1,000; median rate, 9.9/1,000 women).

When looking at all 48 states, the population-weighted mean travel distance to the nearest facility was 25.6 miles, with a median travel distance of 8.2 miles.

A multivariable model showed that a greater travel distance was associated with lower abortion rates. When compared with traveling less than 5 miles, the abortion rate declined by 0.05/1,000 for women traveling between 5 to less than 15 miles for care, 0.22 for those traveling 15 to less than 30 miles, 0.34 for 30 to less than 60 miles, 0.43 for 60 to less than 120 miles, and 0.73 for those traveling 120 miles or more.

They estimated that, if all travel was under 30 miles, there would be a 2.6% increase or 18,190 additional abortions. A simulation also showed that there would be a 10.2% increase (70,920 additional abortions) using medication via telemedicine.
 

Solutions are feasible

Approached for an independent comment, Sarah W. Prager, MD, MAS, professor of obstetrics and gynecology and division chief, complex family planning, at the University of Washington, Seattle, agreed that the solutions proposed by the authors were feasible.

“More than a third of abortions that are eligible are now done with medication,” she said, “And 89% of abortions are done in the first trimester.”

What this means is that early first-trimester abortions can conceivably be performed in the primary care setting. “Any primary care clinician – whether it’s a family practice or internal medicine physician, or nurse practitioner or nurse midwife – can all be trained to do aspiration or prescribe medication in the first trimester,” said Dr. Prager. “So it could easily be integrated into primary care settings if there was motivation for that to happen.”

However, she emphasized that more is involved than just training the provider. “The whole clinic has to buy into it,” Dr. Prager explained. “The nurses have to be willing to assist, you need the medical assistants, the scheduler or person who works the front desk – the whole clinic system has to buy into it and that’s where it becomes more challenging.”

The individual provider may be willing, but the system may still not be allowing that to happen. “This is also where telemedicine can come in, where the medication can be mailed so it can circumvent the problem to a certain extent,” Dr. Prager added. “You don’t have to have the infrastructure in the same way.”

But many states already have laws in place to make that illegal, especially for abortion care even if they allow it for similar types of care.

Another expert also weighed in and agreed that these two solutions can potentially be implemented.

“The concept of decreased rates of abortion associated with greater distances traveled is not new, but what is unique to this manuscript is the estimations that the authors conducted in understanding the impact of expanding access to abortion among primary care and telehealth providers,” said Catherine Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology, University of California, Davis.

“The study provides convincing evidence regarding the need to strengthen infrastructures that support expansion of these services in primary care settings, among physicians and advanced care practitioners,” she said. “Training to provide medical abortion and first-trimester surgical abortion is simple. Many primary care providers are already doing gynecologic procedures – IUD insertions, colposcopies, endometrial biopsies.”

Thus, she noted, adding abortion care “to their toolkit isn’t too far of a stretch.”

As for telemedicine, Dr. Cansino pointed out how the COVID-19 pandemic has also expanded what both patients and providers think are safe options for providing and receiving good care. “Consultations through telemedicine coupled with access to medications for medical abortion through local pharmacies or express mail is definitely safe and feasible.”

The study was supported by the William and Flora Hewlett Foundation and by an anonymous foundation for general operating support (Ms Thompson). Ms. Thompson reported receiving personal fees from GenBioPro outside the submitted work. Dr. Cansino and Dr. Prager have no disclosures.

Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.

Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.

Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.

“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”

Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.

Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.

Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.

Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.

By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.

Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.

Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.

“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”

When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”

In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.

“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.

Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.

Dr. Deligiannidis and Dr. Tanner had no financial disclosures.

Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.

Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.

Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.

“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”

Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.

Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.

Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.

Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.

By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.

Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.

Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.

“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”

When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”

In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.

“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.

Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.

Dr. Deligiannidis and Dr. Tanner had no financial disclosures.

Those suffering from postpartum depression may have a more convenient treatment option, compared with the only drug approved by the Food and Drug Administration to specifically treat this mood disorder.

Observations from phase 3 of a clinical trial published in JAMA Psychiatry shows that zuranolone, an oral drug, improved the core symptoms of postpartum depression after just 3 days.

Postpartum depression affects approximately one in eight women, according to the Centers for Disease Control and Prevention. Brexanolone (Zulresso), which was approved by the FDA in 2019 to treat this condition, is administered intravenously over a 60-hour period with medical supervision.

“Many women don’t have child care and are unable to go to a hospital setting for 72 hours to receive treatment,” study author Kristina Deligiannidis, MD, associate professor at the Feinstein Institutes for Medical Research, Manhasset, N.Y., said in an interview. “The field really does need a variety of new and novel treatments that are fast acting. It is of utmost importance that we treat [postpartum depression] as quickly as possible because it has significant effects on maternal function, mood, and the ability to care for infants.”

Dr. Deligiannidis and colleagues randomly placed 153 volunteers between the ages of 18 and 45 years, who were 6 months or less post partum, into a group that would receive either a placebo or 30 mg of zuranolone daily for 2 weeks. The participants were followed for 45 days to test the effect of the drug.

Researchers measured depression using the Hamilton Rating Scale for Depression (HAMD-17) – where a score of 10-13 means a patient has mild symptoms, 14-17 means mild to moderate symptoms, and anything over 17 equals moderate to severe symptoms. At the baseline of the study, the average HAMD-17 score of those in the zuranolone and placebo groups were 28.4 and 28.8, respectively.

Researchers found that after day 3, 41% of those in the zuranolone group had a 50% or greater reduction in HAMD-17 score from baseline. By day 15, the day after their last dose, 72% of those who had taken zuranolone had a reduction in HAMD-17 compared with 56% of those who had taken the placebo. By day 45, that increased to 75% in the zuranolone group and 57% in the placebo group.

Dr. Deligiannidis, who initially wasn’t sure how long it would take for patients to see the beneficial effects of zuranolone, was surprised by how fast-acting the oral drug appeared to be in the clinical trial. Unlike brexanolone, which is infused into the veins and has rapid access to the brain and nervous system, zuranolone is an oral medicine that has to go through the stomach and the gastrointestinal tract, and then it has to go into the blood system and then has to cross the blood-brain barrier, she explained.

By day 15, 45% of women who took zuranolone received a HAMD-17 score of 7 or under, meaning they have remitted depression. By day 45, 53% of women who had taken the drug were in remission.

Although the zuranolone was well tolerated, about 5% of the group experienced adverse events. Of those who experienced side effects, 15% experienced drowsiness, 9% suffered from headaches, and 8% experienced dizziness and developed an upper respiratory infection. Participants also suffered diarrhea and sedation.

Lissette Tanner, MD, MPH, FACOG, who was not involved with the study, thought the current study’s findings were promising and would be a great alternative to brexanolone.

“You have the additional benefit that it’s an oral agent as opposed to injection, which I know a lot of patients often have concerns about,” said Dr. Tanner, assistant professor of gynecology and obstetrics at Emory University, Atlanta. “[It’s] an exciting prospect for clinical care to be able to prescribe an oral agent patients can feel comfortable taking at home.”

When it comes to the study’s method, Dr. Tanner noted that the researchers used the HAMD-17 scale as opposed to the Edinburgh Postnatal Depression Scale (EPDS), something that is used “a lot more in clinical situations and providers are a lot more familiar with.” Using the EPDS score would be more applicable “in terms of introducing these medications into true clinical care.”

In terms of follow-up, Dr. Tanner said there may be a need for ongoing research that follows the study participants for more than 45 days.

“For depressive symptoms in particular, oftentimes those symptoms ebb and flow. So seeing if there is a long-term response to these medications or just kind of an immediate onset then wane will be important in the future,” she added.

Dr. Tanner is also interested in pharmacokinetic studies involving zuranolone to see how much of the medication may potentially pass into breast milk.

Dr. Deligiannidis and Dr. Tanner had no financial disclosures.

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

The Food and Drug Administration has expanded the approval of secnidazole to include treatment of trichomoniasis in adults, according to a statement from manufacturer Lupin Pharmaceuticals.

Trichomoniasis vaginalis is a common, nonviral, curable sexually transmitted disease that affects approximately 3 million to 5 million adults in the United States each year; the infection can linger for months or years if left untreated, and may have a negative impact on reproductive health. The drug was approved for the treatment of bacterial vaginosis in 2017.

The availability of a single-dose oral treatment for both trichomoniasis and bacterial vaginosis may help improve adherence and reduce risk factors associated with these conditions, including pelvic inflammatory disease and other sexually transmitted infections, according to the statement.

The approval for the new indication was based primarily on data from a phase 3 clinical trial in which women with a confirmed trichomoniasis diagnosis were randomized to a single dose of 2 g oral secnidazole or a placebo. Secnidazole showed a 92.2% cure rate for patients with trichomoniasis, compared with placebo, based on cultures collected 6-12 days after dosing. Cure rates in subsets of patients with HIV and bacterial vaginosis were 100% and 95%, respectively.

The most common treatment-related adverse events were vulvovaginal candidiasis and nausea, each reported in 2.7% of study participants. The study findings were published in March 2021 in Clinical Infections Diseases.

Secnidazole also is approved for treatment of trichomoniasis in men, based on data from four open-label studies, one with men only and three including both men and women, according to the statement.

Full prescribing information for secnidazole is available here.

TUESDAY, 6/29/21. DAY 3 AT SGS

The third day of the annual SGS meeting started with several academic roundtables hosted by experts in the field. These authorities shared their knowledge on a range of topics including endometriosis, building an academic career, diversity and equity in the workplace, and scientific publishing. The general session got underway with additional oral and video presentations highlighting advancements in our field. This year’s SGS President Dr. Miles Murphy gave the annual presidential address. He spoke genuinely and humbly about our field. Whitney Ross, MD, (@WRossMD), referred to his speech on Twitter as “Best. Presidential. Address. Ever.” –a sentiment felt by many in the crowd!

This year’s Telinde Lecture was given by Janet Dombrowski, the first ever non-physician to present this lecture. She spoke on resiliency in a lecture titled, “Cultivating Resilience: The Power in Connection & Collaboration.” It was an insightful and wise presentation on the power of connection and how connection bolsters our resiliency. She challenged us to all break down “thinking habits” that isolate us into silos and get in the way of powerful connection and collaboration. She reminded us of the African greeting “Sawubona” (I see you) and “Sikhona” (Because you see me, I am here). A gentle reminder that we feel our existence most tangibly when we are seen by others—an idea consistent with other important themes of this conference, focused on diversity, equity, and inclusion of all.  The morning session was rounded out with a panel discussion on “Novel GYN Office Procedure,” featuring Drs. Cecile Ferrando (@CFerrandoMD), Abbas Shobeiri (@ShobeiriAbbas), Andrea Pezzela, and Eric Sokol.

The afternoon was filled with leisure activities in beautiful Palm Springs, including the SGS Golf Tournament, mountain biking, aerial tramway tour, and hike. The weather even cooperated with slightly cooler temperatures (think 100℉ instead of 120℉)! The evening was filled with food, drinks, and the excitement around the annual “SGS’ Got Talent” show! Everyone was able to let down, show off their dance moves, and enjoy some of that much needed connection time!

Tomorrow is the last day of #SGS2021! Excited to round out the conference with continued learning.

MONDAY, 6/28/21. DAY 2 AT SGS 

 The sun is up and working hard here in Palm Springs, and so are we!  
 
Welcome and introduction of new members 
 
The general session started with a warm welcome to the 12 new SGS members. A special shout out to Dr. Kelly Wright who is a new SGS Member and won the #SGS2021 tweetup! She ranked as a top influencer, prolific tweeter, and made more than 250K impressions leading up to SGS! Way to represent @MigsRunner.  
 
General scientific sessions 
 
There were several excellent oral and video presentations throughout the morning session. A range of topics were discussed, including postoperative pain management, strategies for cost-effective surgery, and how racial and ethnic disparities play into our medical education and patient outcomes. Dr. Eva Welch gave a stellar video presentation on straight-stick sacrocolpopexy techniques for the savvy surgeon. I personally will be incorporating some of her needle management tricks!  
 
After a brief break with some refreshments and a stroll around the exhibit hall, the second scientific session initiated with a transformative lecture. Dr. Mark Walters presented "Insights on Surgical Education: How Can I Help You Get Better" in the inaugural Mark D. Walters Lectureship. Dr. Walters shared his experience and insights on how to transform oneself from a good surgeon to an expert and from a teacher to a coach in the operating room. His dedication to our field, years of experience, and wisdom earned him a standing ovation! Additional oral and video presentations followed. Dr. J. Wong shared correlations between surgeon gender and ergonomic strain with laparoscopic devices. Female surgeons more often reported inappropriate fit and expressed physical discomfort compared with male surgeons. Injuries and ergonomic strain lead to less operating and even disability for some surgeons. It is past time for us to have better--we need instruments that fit our hands!  
 
The afternoon session started with a panel on "Perspectives on Race in GYN Surgery." It was another insightful discussion with thought- and action-provoking knowledge. The afternoon session included the SGS Prize Video by Dr. Angela DiCarlo-Meacham on excision of a vulvar cyst.  
 
Fellows' Pelvic Research Network 
 
After adjourning of the scientific sessions, the fellow-ran, multicenter research network (FPRN) met to give updates. This diverse group of both AUGS-SGS and FMIGS-SGS offers mentorship and relationships that are important for future careers and research. The collaboration allows the study of rare outcomes that may not be feasible at single sites. Dr. Amanda Yunker, fellowship director at Vanderbilt University, gave an amazing history lesson on the fields of OB and GYN, and the evolution of gynecologic surgery. We then had fun assigning a "report card grade" on how MIGS is doing comparatively with other subspecialties in the realms of academics and research.  
 
VideoFest 
 
The late afternoon was concluded with a surgical video session. What an amazing and talented group we are here at SGS!  
 
President's awards ceremony and reception 
The scientific focused day was rounded out with an evening of honors, awards, and social time as we celebrated all the achievements of our peers and colleagues. The president's reception was filled with food, laughter, networking, and reconnecting with friends and colleagues. We are looking forward to another day of education tomorrow! 
 
Follow @JennaRehmerMD, @GynSurgery, and #SGS2021 on Twitter for updates. 

SUNDAY, 6/27/21. DAY 1 AT SGS

Hello live from sunny Palm Spring, CA, and the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS)! This year’s conference balances the long-awaited return to in-person events while simultaneously embracing virtual learning with their hybrid meeting format. You can follow me, @JennaRehmerMD, and #SGS2021 in real-time on Twitter. 

Dismantling racism

We were incredibly fortunate to take a deep dive into dismantling racism in our personal and professional spheres. The postgraduate course was well researched and presented by Drs. Oluwateniola “Teni” Brown, Cassandra Carberry, Olivia Cardenas-Trowers (@otrowers_md), Annetta Madsen, Moiuri Siddique, and Blair Washington (@Dr_B_Washington). Each presentation provided a succinct and cohesive flow, taking us through what racism is, the historical and active structural racism in medicine, and the actions and steps of becoming anti-racist. 

Dr. Brown discussed critical race theory. We learned that the engineered system of oppression is so advanced that it is often hidden in plain sight, and that one’s conscious awareness is not necessary in order to uphold the system of oppression. It is reinforced and supported with minimal effort. This is why not being racist is not enough; active anti-racism is needed to bring about change. 

Fibroid management

Across the hall, Drs. Linda Bradley (@BradlelMD), Kimberly Kho (@KimberlyKho1), Cara King (@drcaraking), and Kelly Wright (@MigsRunner) broadened our armamentarium for uterine conservation in fibroid management. Dr. Bradley reviewed medical therapies, including novel treatments, as first-line or adjunct treatment options. Next, the course focused on surgical techniques for hysteroscopic myomectomies, optimization of minilaparotomy for myomectomy, and tissue extraction. Dr. King displayed true grit when giving her lecture from the airport after flight delays prevented her from being in person with us. 

Multidisciplinary care within gyn surgery

In this virtual only postgraduate course, Drs. Risal Djohan (@DjohanMD), Cecile Ferrando (@CFerrandoMD), Marie Fidela Paraiso, Sandip Vasavada (@SandipVasavada), and Sarah Vogler showed us the importance of multidisciplinary care within gynecologic surgery practices. They explored how to streamline the approach so it complements your practice, how to co-bill for shared patient care, and tips and tricks for optimizing the surgical experience for the patient. 

Industry presentations

Over lunch, Dr. Opoku-Akane presented on using ERAS (enhanced recovery after surgery) protocols for endometriosis and chronic pelvic pain and how to optimize the use of alternative surgical modalities for endometriosis. Following this, Drs. Albert Huany and Craig McCoy taught about a new technology using electrical stimulation to optimize visualization of the ureter. 

Harnessing the power of social media

This workshop, organized by SGS Social Media Committee Chair Dr. Amy Park (@dramypark) showed us the importance of having an online identity for the sharing of ideas, networking, professional development, and education. We learned how to optimize our online bios, proper use of GYN ontology for hashtags, and how to maintain professionalism on social media. We reviewed the data on how sharing publications on social media improves altmetric scores and discussed how our social media influence may be tied to performance in the future. 

Lessons in leadership

We rounded out the day with after-dinner dessert and drinks at the evening SGS Women’s Council presentation. We had the great honor of hearing from Lori Ryerker, CEO of Celanese Corporation, a Fortune 500 global company. She provided much wisdom on being a leader. She shared several keys to creating a successful work environment:

• being a leader that “provides an environment where people feel like they can bring their best selves every day” (and that being your best self is being your whole self, without reservations)
• allowing all genders, sexual orientations, races, ethnicities, and ages to show up together without reservations (because only then can people feel safe to be their best, because their best self is their true self). 

It was a wonderful and successful kick-off to the meeting. I look forward to a full day tomorrow! Follow along as this year’s Fellow Scholars, Drs. Tara Brah (@TaraBrah), Amr El Haraki (@drharaki), Sheena Galhotra (@SheenaGalhotra), Meenal Misal (@meenalmisalMD), and yours truly, post live updates daily.

TUESDAY, 6/29/21. DAY 3 AT SGS

The third day of the annual SGS meeting started with several academic roundtables hosted by experts in the field. These authorities shared their knowledge on a range of topics including endometriosis, building an academic career, diversity and equity in the workplace, and scientific publishing. The general session got underway with additional oral and video presentations highlighting advancements in our field. This year’s SGS President Dr. Miles Murphy gave the annual presidential address. He spoke genuinely and humbly about our field. Whitney Ross, MD, (@WRossMD), referred to his speech on Twitter as “Best. Presidential. Address. Ever.” –a sentiment felt by many in the crowd!

This year’s Telinde Lecture was given by Janet Dombrowski, the first ever non-physician to present this lecture. She spoke on resiliency in a lecture titled, “Cultivating Resilience: The Power in Connection & Collaboration.” It was an insightful and wise presentation on the power of connection and how connection bolsters our resiliency. She challenged us to all break down “thinking habits” that isolate us into silos and get in the way of powerful connection and collaboration. She reminded us of the African greeting “Sawubona” (I see you) and “Sikhona” (Because you see me, I am here). A gentle reminder that we feel our existence most tangibly when we are seen by others—an idea consistent with other important themes of this conference, focused on diversity, equity, and inclusion of all.  The morning session was rounded out with a panel discussion on “Novel GYN Office Procedure,” featuring Drs. Cecile Ferrando (@CFerrandoMD), Abbas Shobeiri (@ShobeiriAbbas), Andrea Pezzela, and Eric Sokol.

The afternoon was filled with leisure activities in beautiful Palm Springs, including the SGS Golf Tournament, mountain biking, aerial tramway tour, and hike. The weather even cooperated with slightly cooler temperatures (think 100℉ instead of 120℉)! The evening was filled with food, drinks, and the excitement around the annual “SGS’ Got Talent” show! Everyone was able to let down, show off their dance moves, and enjoy some of that much needed connection time!

Tomorrow is the last day of #SGS2021! Excited to round out the conference with continued learning.

MONDAY, 6/28/21. DAY 2 AT SGS 

 The sun is up and working hard here in Palm Springs, and so are we!  
 
Welcome and introduction of new members 
 
The general session started with a warm welcome to the 12 new SGS members. A special shout out to Dr. Kelly Wright who is a new SGS Member and won the #SGS2021 tweetup! She ranked as a top influencer, prolific tweeter, and made more than 250K impressions leading up to SGS! Way to represent @MigsRunner.  
 
General scientific sessions 
 
There were several excellent oral and video presentations throughout the morning session. A range of topics were discussed, including postoperative pain management, strategies for cost-effective surgery, and how racial and ethnic disparities play into our medical education and patient outcomes. Dr. Eva Welch gave a stellar video presentation on straight-stick sacrocolpopexy techniques for the savvy surgeon. I personally will be incorporating some of her needle management tricks!  
 
After a brief break with some refreshments and a stroll around the exhibit hall, the second scientific session initiated with a transformative lecture. Dr. Mark Walters presented "Insights on Surgical Education: How Can I Help You Get Better" in the inaugural Mark D. Walters Lectureship. Dr. Walters shared his experience and insights on how to transform oneself from a good surgeon to an expert and from a teacher to a coach in the operating room. His dedication to our field, years of experience, and wisdom earned him a standing ovation! Additional oral and video presentations followed. Dr. J. Wong shared correlations between surgeon gender and ergonomic strain with laparoscopic devices. Female surgeons more often reported inappropriate fit and expressed physical discomfort compared with male surgeons. Injuries and ergonomic strain lead to less operating and even disability for some surgeons. It is past time for us to have better--we need instruments that fit our hands!  
 
The afternoon session started with a panel on "Perspectives on Race in GYN Surgery." It was another insightful discussion with thought- and action-provoking knowledge. The afternoon session included the SGS Prize Video by Dr. Angela DiCarlo-Meacham on excision of a vulvar cyst.  
 
Fellows' Pelvic Research Network 
 
After adjourning of the scientific sessions, the fellow-ran, multicenter research network (FPRN) met to give updates. This diverse group of both AUGS-SGS and FMIGS-SGS offers mentorship and relationships that are important for future careers and research. The collaboration allows the study of rare outcomes that may not be feasible at single sites. Dr. Amanda Yunker, fellowship director at Vanderbilt University, gave an amazing history lesson on the fields of OB and GYN, and the evolution of gynecologic surgery. We then had fun assigning a "report card grade" on how MIGS is doing comparatively with other subspecialties in the realms of academics and research.  
 
VideoFest 
 
The late afternoon was concluded with a surgical video session. What an amazing and talented group we are here at SGS!  
 
President's awards ceremony and reception 
The scientific focused day was rounded out with an evening of honors, awards, and social time as we celebrated all the achievements of our peers and colleagues. The president's reception was filled with food, laughter, networking, and reconnecting with friends and colleagues. We are looking forward to another day of education tomorrow! 
 
Follow @JennaRehmerMD, @GynSurgery, and #SGS2021 on Twitter for updates. 

SUNDAY, 6/27/21. DAY 1 AT SGS

Hello live from sunny Palm Spring, CA, and the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS)! This year’s conference balances the long-awaited return to in-person events while simultaneously embracing virtual learning with their hybrid meeting format. You can follow me, @JennaRehmerMD, and #SGS2021 in real-time on Twitter. 

Dismantling racism

We were incredibly fortunate to take a deep dive into dismantling racism in our personal and professional spheres. The postgraduate course was well researched and presented by Drs. Oluwateniola “Teni” Brown, Cassandra Carberry, Olivia Cardenas-Trowers (@otrowers_md), Annetta Madsen, Moiuri Siddique, and Blair Washington (@Dr_B_Washington). Each presentation provided a succinct and cohesive flow, taking us through what racism is, the historical and active structural racism in medicine, and the actions and steps of becoming anti-racist. 

Dr. Brown discussed critical race theory. We learned that the engineered system of oppression is so advanced that it is often hidden in plain sight, and that one’s conscious awareness is not necessary in order to uphold the system of oppression. It is reinforced and supported with minimal effort. This is why not being racist is not enough; active anti-racism is needed to bring about change. 

Fibroid management

Across the hall, Drs. Linda Bradley (@BradlelMD), Kimberly Kho (@KimberlyKho1), Cara King (@drcaraking), and Kelly Wright (@MigsRunner) broadened our armamentarium for uterine conservation in fibroid management. Dr. Bradley reviewed medical therapies, including novel treatments, as first-line or adjunct treatment options. Next, the course focused on surgical techniques for hysteroscopic myomectomies, optimization of minilaparotomy for myomectomy, and tissue extraction. Dr. King displayed true grit when giving her lecture from the airport after flight delays prevented her from being in person with us. 

Multidisciplinary care within gyn surgery

In this virtual only postgraduate course, Drs. Risal Djohan (@DjohanMD), Cecile Ferrando (@CFerrandoMD), Marie Fidela Paraiso, Sandip Vasavada (@SandipVasavada), and Sarah Vogler showed us the importance of multidisciplinary care within gynecologic surgery practices. They explored how to streamline the approach so it complements your practice, how to co-bill for shared patient care, and tips and tricks for optimizing the surgical experience for the patient. 

Industry presentations

Over lunch, Dr. Opoku-Akane presented on using ERAS (enhanced recovery after surgery) protocols for endometriosis and chronic pelvic pain and how to optimize the use of alternative surgical modalities for endometriosis. Following this, Drs. Albert Huany and Craig McCoy taught about a new technology using electrical stimulation to optimize visualization of the ureter. 

Harnessing the power of social media

This workshop, organized by SGS Social Media Committee Chair Dr. Amy Park (@dramypark) showed us the importance of having an online identity for the sharing of ideas, networking, professional development, and education. We learned how to optimize our online bios, proper use of GYN ontology for hashtags, and how to maintain professionalism on social media. We reviewed the data on how sharing publications on social media improves altmetric scores and discussed how our social media influence may be tied to performance in the future. 

Lessons in leadership

We rounded out the day with after-dinner dessert and drinks at the evening SGS Women’s Council presentation. We had the great honor of hearing from Lori Ryerker, CEO of Celanese Corporation, a Fortune 500 global company. She provided much wisdom on being a leader. She shared several keys to creating a successful work environment:

• being a leader that “provides an environment where people feel like they can bring their best selves every day” (and that being your best self is being your whole self, without reservations)
• allowing all genders, sexual orientations, races, ethnicities, and ages to show up together without reservations (because only then can people feel safe to be their best, because their best self is their true self). 

It was a wonderful and successful kick-off to the meeting. I look forward to a full day tomorrow! Follow along as this year’s Fellow Scholars, Drs. Tara Brah (@TaraBrah), Amr El Haraki (@drharaki), Sheena Galhotra (@SheenaGalhotra), Meenal Misal (@meenalmisalMD), and yours truly, post live updates daily.

TUESDAY, 6/29/21. DAY 3 AT SGS

The third day of the annual SGS meeting started with several academic roundtables hosted by experts in the field. These authorities shared their knowledge on a range of topics including endometriosis, building an academic career, diversity and equity in the workplace, and scientific publishing. The general session got underway with additional oral and video presentations highlighting advancements in our field. This year’s SGS President Dr. Miles Murphy gave the annual presidential address. He spoke genuinely and humbly about our field. Whitney Ross, MD, (@WRossMD), referred to his speech on Twitter as “Best. Presidential. Address. Ever.” –a sentiment felt by many in the crowd!

This year’s Telinde Lecture was given by Janet Dombrowski, the first ever non-physician to present this lecture. She spoke on resiliency in a lecture titled, “Cultivating Resilience: The Power in Connection & Collaboration.” It was an insightful and wise presentation on the power of connection and how connection bolsters our resiliency. She challenged us to all break down “thinking habits” that isolate us into silos and get in the way of powerful connection and collaboration. She reminded us of the African greeting “Sawubona” (I see you) and “Sikhona” (Because you see me, I am here). A gentle reminder that we feel our existence most tangibly when we are seen by others—an idea consistent with other important themes of this conference, focused on diversity, equity, and inclusion of all.  The morning session was rounded out with a panel discussion on “Novel GYN Office Procedure,” featuring Drs. Cecile Ferrando (@CFerrandoMD), Abbas Shobeiri (@ShobeiriAbbas), Andrea Pezzela, and Eric Sokol.

The afternoon was filled with leisure activities in beautiful Palm Springs, including the SGS Golf Tournament, mountain biking, aerial tramway tour, and hike. The weather even cooperated with slightly cooler temperatures (think 100℉ instead of 120℉)! The evening was filled with food, drinks, and the excitement around the annual “SGS’ Got Talent” show! Everyone was able to let down, show off their dance moves, and enjoy some of that much needed connection time!

Tomorrow is the last day of #SGS2021! Excited to round out the conference with continued learning.

MONDAY, 6/28/21. DAY 2 AT SGS 

 The sun is up and working hard here in Palm Springs, and so are we!  
 
Welcome and introduction of new members 
 
The general session started with a warm welcome to the 12 new SGS members. A special shout out to Dr. Kelly Wright who is a new SGS Member and won the #SGS2021 tweetup! She ranked as a top influencer, prolific tweeter, and made more than 250K impressions leading up to SGS! Way to represent @MigsRunner.  
 
General scientific sessions 
 
There were several excellent oral and video presentations throughout the morning session. A range of topics were discussed, including postoperative pain management, strategies for cost-effective surgery, and how racial and ethnic disparities play into our medical education and patient outcomes. Dr. Eva Welch gave a stellar video presentation on straight-stick sacrocolpopexy techniques for the savvy surgeon. I personally will be incorporating some of her needle management tricks!  
 
After a brief break with some refreshments and a stroll around the exhibit hall, the second scientific session initiated with a transformative lecture. Dr. Mark Walters presented "Insights on Surgical Education: How Can I Help You Get Better" in the inaugural Mark D. Walters Lectureship. Dr. Walters shared his experience and insights on how to transform oneself from a good surgeon to an expert and from a teacher to a coach in the operating room. His dedication to our field, years of experience, and wisdom earned him a standing ovation! Additional oral and video presentations followed. Dr. J. Wong shared correlations between surgeon gender and ergonomic strain with laparoscopic devices. Female surgeons more often reported inappropriate fit and expressed physical discomfort compared with male surgeons. Injuries and ergonomic strain lead to less operating and even disability for some surgeons. It is past time for us to have better--we need instruments that fit our hands!  
 
The afternoon session started with a panel on "Perspectives on Race in GYN Surgery." It was another insightful discussion with thought- and action-provoking knowledge. The afternoon session included the SGS Prize Video by Dr. Angela DiCarlo-Meacham on excision of a vulvar cyst.  
 
Fellows' Pelvic Research Network 
 
After adjourning of the scientific sessions, the fellow-ran, multicenter research network (FPRN) met to give updates. This diverse group of both AUGS-SGS and FMIGS-SGS offers mentorship and relationships that are important for future careers and research. The collaboration allows the study of rare outcomes that may not be feasible at single sites. Dr. Amanda Yunker, fellowship director at Vanderbilt University, gave an amazing history lesson on the fields of OB and GYN, and the evolution of gynecologic surgery. We then had fun assigning a "report card grade" on how MIGS is doing comparatively with other subspecialties in the realms of academics and research.  
 
VideoFest 
 
The late afternoon was concluded with a surgical video session. What an amazing and talented group we are here at SGS!  
 
President's awards ceremony and reception 
The scientific focused day was rounded out with an evening of honors, awards, and social time as we celebrated all the achievements of our peers and colleagues. The president's reception was filled with food, laughter, networking, and reconnecting with friends and colleagues. We are looking forward to another day of education tomorrow! 
 
Follow @JennaRehmerMD, @GynSurgery, and #SGS2021 on Twitter for updates. 

SUNDAY, 6/27/21. DAY 1 AT SGS

Hello live from sunny Palm Spring, CA, and the Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS)! This year’s conference balances the long-awaited return to in-person events while simultaneously embracing virtual learning with their hybrid meeting format. You can follow me, @JennaRehmerMD, and #SGS2021 in real-time on Twitter. 

Dismantling racism

We were incredibly fortunate to take a deep dive into dismantling racism in our personal and professional spheres. The postgraduate course was well researched and presented by Drs. Oluwateniola “Teni” Brown, Cassandra Carberry, Olivia Cardenas-Trowers (@otrowers_md), Annetta Madsen, Moiuri Siddique, and Blair Washington (@Dr_B_Washington). Each presentation provided a succinct and cohesive flow, taking us through what racism is, the historical and active structural racism in medicine, and the actions and steps of becoming anti-racist. 

Dr. Brown discussed critical race theory. We learned that the engineered system of oppression is so advanced that it is often hidden in plain sight, and that one’s conscious awareness is not necessary in order to uphold the system of oppression. It is reinforced and supported with minimal effort. This is why not being racist is not enough; active anti-racism is needed to bring about change. 

Fibroid management

Across the hall, Drs. Linda Bradley (@BradlelMD), Kimberly Kho (@KimberlyKho1), Cara King (@drcaraking), and Kelly Wright (@MigsRunner) broadened our armamentarium for uterine conservation in fibroid management. Dr. Bradley reviewed medical therapies, including novel treatments, as first-line or adjunct treatment options. Next, the course focused on surgical techniques for hysteroscopic myomectomies, optimization of minilaparotomy for myomectomy, and tissue extraction. Dr. King displayed true grit when giving her lecture from the airport after flight delays prevented her from being in person with us. 

Multidisciplinary care within gyn surgery

In this virtual only postgraduate course, Drs. Risal Djohan (@DjohanMD), Cecile Ferrando (@CFerrandoMD), Marie Fidela Paraiso, Sandip Vasavada (@SandipVasavada), and Sarah Vogler showed us the importance of multidisciplinary care within gynecologic surgery practices. They explored how to streamline the approach so it complements your practice, how to co-bill for shared patient care, and tips and tricks for optimizing the surgical experience for the patient. 

Industry presentations

Over lunch, Dr. Opoku-Akane presented on using ERAS (enhanced recovery after surgery) protocols for endometriosis and chronic pelvic pain and how to optimize the use of alternative surgical modalities for endometriosis. Following this, Drs. Albert Huany and Craig McCoy taught about a new technology using electrical stimulation to optimize visualization of the ureter. 

Harnessing the power of social media

This workshop, organized by SGS Social Media Committee Chair Dr. Amy Park (@dramypark) showed us the importance of having an online identity for the sharing of ideas, networking, professional development, and education. We learned how to optimize our online bios, proper use of GYN ontology for hashtags, and how to maintain professionalism on social media. We reviewed the data on how sharing publications on social media improves altmetric scores and discussed how our social media influence may be tied to performance in the future. 

Lessons in leadership

We rounded out the day with after-dinner dessert and drinks at the evening SGS Women’s Council presentation. We had the great honor of hearing from Lori Ryerker, CEO of Celanese Corporation, a Fortune 500 global company. She provided much wisdom on being a leader. She shared several keys to creating a successful work environment:

• being a leader that “provides an environment where people feel like they can bring their best selves every day” (and that being your best self is being your whole self, without reservations)
• allowing all genders, sexual orientations, races, ethnicities, and ages to show up together without reservations (because only then can people feel safe to be their best, because their best self is their true self). 

It was a wonderful and successful kick-off to the meeting. I look forward to a full day tomorrow! Follow along as this year’s Fellow Scholars, Drs. Tara Brah (@TaraBrah), Amr El Haraki (@drharaki), Sheena Galhotra (@SheenaGalhotra), Meenal Misal (@meenalmisalMD), and yours truly, post live updates daily.

Ultrasonography truly has revolutionized the practice of obstetrics and gynecology. Initially, transabdominal ultrasonography was mainly a tool of the obstetrician. Early linear array, real-time equipment had barely enough resolution to perform very limited assessments, such as measure biparietal diameter and identify vertex versus breech presentation, and anterior versus posterior placenta location. The introduction of transvaginal probes, which employ higher frequency and provide closer proximity to structures, yielded a degree of image magnification that was dubbed sonomicroscopy.¹ In other words, we are seeing things with our naked eye that we could not see if we could hold them in our hand at arm’s length and squint at them. An example of this is the cardiac activity clearly visible in a 3-mm embryo at 45 days from the last menstrual period. One would not appreciate this without the low power magnification of the vaginal probe.

The concept of dynamic imaging

As early as 1990, I realized that there is a difference between an ultrasound “examination” performed because of referral for imaging, which generated a report back to the referring health care provider, and “examining” one’s own patient with ultrasonography at the time of bimanual exam. I coined the phrase “the ultrasound-enhanced bimanual exam,” and I believed it should become a routine part of gynecologic care. I put forth this thesis in an article entitled, “Incorporating endovaginal ultrasonography into the overall gynecologic examination.”² The idea is based on thinking: What exactly are we are trying to discern from a bimanual exam?

Clinicians perform the bimanual exam thousands of times. The bimanual examination consists of 2 components, an objective portion and a subjective portion. The objective component attempts to discern information that is totally objective, such as, Is the ovary enlarged? If so, is it cystic or solid? Is this uterus normal in shape and contour? If so, does it feel like leiomyomas or is it globularly enlarged as with adenomyosis? The subjective component of the bimanual examination attempts to determine whether or not tenderness is present or if there is normal mobility of the pelvic organs.

The objective component can be replaced by an image in very little time if the examiner has the equipment and the knowledge and skill. The subjective component, however, depends on the experience and often the nuance of the examiner. That was my original thought process. I wanted, and still want, the examining clinician to use imaging as part of the overall exam. But now, I want the imager to use examination as part of the overall imaging. (VIDEOS 1A and 1B.) This is the concept of dynamic imaging. It involves the liberal use of the abdominal hand as well as an in-and-out motion of the vaginal probe to ascertain aspects of the examination that in the past I deemed “subjective.” Mainly, this involves the aspects of mobility and/or tenderness.

Continue to: Guidelines concerning pelvic ultrasound do not consider dynamic imaging...

Guidelines concerning pelvic ultrasound do not consider dynamic imaging

Until now, most imagers take a myriad of pictures, mostly still snapshots, to illustrate anatomy. Most imaging physicians then look at a series of such pictures and may never even hold the transducer. This is increasingly true in instances of remote teleradiology. Even for the minority of imagers who utilize video clips (VIDEOS 2A–2C), these are still representations of anatomy .

One need look no further than the guidelines that underpin the expectation of those who scan the female pelvis. The American Institute of Ultrasound in Medicine (AIUM) published a practice parameter for the performance of ultrasonography of the female pelvis, developed in collaboration with the American College of Radiology, American College of Obstetricians and Gynecologists, Society for Pediatric Radiology, and Society of Radiologists in Ultrasound. ³ Nowhere does this document mention anything other than what images to obtain, where to look, and how to measure. Nowhere is there any mention of dynamic imaging—the concept of using one’s other hand on the abdomen, eliciting pain with the vaginal probe, checking for mobility, asking the patient to bear down. The document lists indications for pelvic sonography that include but are not limited to 19 different indications, such as pelvic pain, evaluation of dysmenorrhea, evaluation for signs or symptoms of pelvic infection, and evaluation of incontinence or pelvic organ prolapse (TABLE). ³

Dynamic ultrasonography can aid in the diagnosis of certain conditions

Specifically, what can dynamic ultrasonography add to anatomic imaging? The main considerations are pain, adhesions, endometriosis, and pelvic organ prolapse.

Pelvic pain or tenderness

How can you evaluate a patient’s pelvic pain with an anatomic image? Perhaps pain can be corroborated if there is a classic ovarian endometrioma (FIGURE 1) (VIDEOS 3A, 3B) or classic hydrosalpinx (FIGURE 2) (VIDEOS 4A–4C). But can we evaluate pelvic pain with only an anatomic image? No, absolutely not. Evaluating pain requires dynamic assessment. As described above, in a dynamic ultrasound assessment, liberal use of the abdominal hand and the tip of the vaginal probe can elicit where the patient’s pain exists and whether the pain can be recreated.

Adhesions

Pelvic adhesions can be a significant source of pelvic pain and, also, sometimes infertility. The adhesions themselves may not be visible on anatomic imaging. This is where the concept of the sliding organ sign is paramount, a concept first described by Dr. Ilan Timor-Tritsch in his book Transvaginal Sonography . ⁴ He stated, “Diagnosis of pelvic adhesions becomes possible by the ‘sliding organ sign.’ The transducer tip is pointed at the uterus, ovaries or any pelvic finding, and a gentle push-pull movement of several centimeters is started. If no adhesions are present, the organs will move freely in the pelvis. This displacement of organs is perceived on the screen as a sliding movement.” ⁴ Thus, if structures are in fact adherent, they will move in tandem with each other as evidenced by this dynamic assessment. If they are not adherent, they will move slightly but independently of each other ( VIDEOS 5A–5G ).

Continue to: Endometriosis...

Endometriosis

Dynamic ultrasonography can be a significant part of a nonlaparoscopic, presumptive diagnosis of endometriosis when there is no obvious ovarian endometrioma.⁵ The evidence for this comes from a classic paper by Okaro and colleagues, “The use of ultrasound‐based ‘soft markers’ for the prediction of pelvic pathology in women with chronic pelvic pain–can we reduce the need for laparoscopy?”⁶ In that study, 120 consecutive women with chronic pelvic pain scheduled for laparoscopy underwent vaginal ultrasonography. Hard markers were defined as structural abnormalities, such as classic endometriomas or hydrosalpinges.

These markers demonstrated a 100% correlation (24 of 24 women) with laparoscopic findings, as one might have suspected. In addition, soft markers (VIDEOS 6A–6C) were defined as reduced ovarian mobility, site-specific pelvic tenderness, and the presence of loculated peritoneal fluid in the pelvis. These were predictive of pelvic pathology in 73% of these women (37 of 51).⁶

Thus, women who have soft markers on dynamic scanning but no obvious anatomic abnormalities can be treated with a high degree of sensitivity without the need for laparoscopic intervention.

Pelvic organ prolapse and incontinence

With the vaginal probe in place, and even a small amount of urine in the bladder, the patient can be asked to bear down (Valsalva maneuver), and cystocele (VIDEO 7) and/or hypermobility of the urethra (VIDEO 8) is easily discerned with dynamic ultrasonography. This information is not available on static anatomic imaging.

A tool that enhances patient care

Dynamic ultrasonography is an important and emerging topic in gynecologic imaging. Static images and even cine clips will yield only anatomic information. Increasingly, whoever holds the transducer—whether it be the gynecologist, radiologist, or sonographer—needs to examine the patient with the probe and include liberal use of the abdominal hand as well. Incorporating this concept will enhance the overall diagnostic input of ultrasound scanning, not just imaging, into better and more accurate patient care. ●

Ultrasonography truly has revolutionized the practice of obstetrics and gynecology. Initially, transabdominal ultrasonography was mainly a tool of the obstetrician. Early linear array, real-time equipment had barely enough resolution to perform very limited assessments, such as measure biparietal diameter and identify vertex versus breech presentation, and anterior versus posterior placenta location. The introduction of transvaginal probes, which employ higher frequency and provide closer proximity to structures, yielded a degree of image magnification that was dubbed sonomicroscopy.¹ In other words, we are seeing things with our naked eye that we could not see if we could hold them in our hand at arm’s length and squint at them. An example of this is the cardiac activity clearly visible in a 3-mm embryo at 45 days from the last menstrual period. One would not appreciate this without the low power magnification of the vaginal probe.

The concept of dynamic imaging

As early as 1990, I realized that there is a difference between an ultrasound “examination” performed because of referral for imaging, which generated a report back to the referring health care provider, and “examining” one’s own patient with ultrasonography at the time of bimanual exam. I coined the phrase “the ultrasound-enhanced bimanual exam,” and I believed it should become a routine part of gynecologic care. I put forth this thesis in an article entitled, “Incorporating endovaginal ultrasonography into the overall gynecologic examination.”² The idea is based on thinking: What exactly are we are trying to discern from a bimanual exam?

Clinicians perform the bimanual exam thousands of times. The bimanual examination consists of 2 components, an objective portion and a subjective portion. The objective component attempts to discern information that is totally objective, such as, Is the ovary enlarged? If so, is it cystic or solid? Is this uterus normal in shape and contour? If so, does it feel like leiomyomas or is it globularly enlarged as with adenomyosis? The subjective component of the bimanual examination attempts to determine whether or not tenderness is present or if there is normal mobility of the pelvic organs.

The objective component can be replaced by an image in very little time if the examiner has the equipment and the knowledge and skill. The subjective component, however, depends on the experience and often the nuance of the examiner. That was my original thought process. I wanted, and still want, the examining clinician to use imaging as part of the overall exam. But now, I want the imager to use examination as part of the overall imaging. (VIDEOS 1A and 1B.) This is the concept of dynamic imaging. It involves the liberal use of the abdominal hand as well as an in-and-out motion of the vaginal probe to ascertain aspects of the examination that in the past I deemed “subjective.” Mainly, this involves the aspects of mobility and/or tenderness.

Continue to: Guidelines concerning pelvic ultrasound do not consider dynamic imaging...

Guidelines concerning pelvic ultrasound do not consider dynamic imaging

Until now, most imagers take a myriad of pictures, mostly still snapshots, to illustrate anatomy. Most imaging physicians then look at a series of such pictures and may never even hold the transducer. This is increasingly true in instances of remote teleradiology. Even for the minority of imagers who utilize video clips (VIDEOS 2A–2C), these are still representations of anatomy .

One need look no further than the guidelines that underpin the expectation of those who scan the female pelvis. The American Institute of Ultrasound in Medicine (AIUM) published a practice parameter for the performance of ultrasonography of the female pelvis, developed in collaboration with the American College of Radiology, American College of Obstetricians and Gynecologists, Society for Pediatric Radiology, and Society of Radiologists in Ultrasound. ³ Nowhere does this document mention anything other than what images to obtain, where to look, and how to measure. Nowhere is there any mention of dynamic imaging—the concept of using one’s other hand on the abdomen, eliciting pain with the vaginal probe, checking for mobility, asking the patient to bear down. The document lists indications for pelvic sonography that include but are not limited to 19 different indications, such as pelvic pain, evaluation of dysmenorrhea, evaluation for signs or symptoms of pelvic infection, and evaluation of incontinence or pelvic organ prolapse (TABLE). ³

Dynamic ultrasonography can aid in the diagnosis of certain conditions

Specifically, what can dynamic ultrasonography add to anatomic imaging? The main considerations are pain, adhesions, endometriosis, and pelvic organ prolapse.

Pelvic pain or tenderness

How can you evaluate a patient’s pelvic pain with an anatomic image? Perhaps pain can be corroborated if there is a classic ovarian endometrioma (FIGURE 1) (VIDEOS 3A, 3B) or classic hydrosalpinx (FIGURE 2) (VIDEOS 4A–4C). But can we evaluate pelvic pain with only an anatomic image? No, absolutely not. Evaluating pain requires dynamic assessment. As described above, in a dynamic ultrasound assessment, liberal use of the abdominal hand and the tip of the vaginal probe can elicit where the patient’s pain exists and whether the pain can be recreated.

Adhesions

Pelvic adhesions can be a significant source of pelvic pain and, also, sometimes infertility. The adhesions themselves may not be visible on anatomic imaging. This is where the concept of the sliding organ sign is paramount, a concept first described by Dr. Ilan Timor-Tritsch in his book Transvaginal Sonography . ⁴ He stated, “Diagnosis of pelvic adhesions becomes possible by the ‘sliding organ sign.’ The transducer tip is pointed at the uterus, ovaries or any pelvic finding, and a gentle push-pull movement of several centimeters is started. If no adhesions are present, the organs will move freely in the pelvis. This displacement of organs is perceived on the screen as a sliding movement.” ⁴ Thus, if structures are in fact adherent, they will move in tandem with each other as evidenced by this dynamic assessment. If they are not adherent, they will move slightly but independently of each other ( VIDEOS 5A–5G ).

Continue to: Endometriosis...

Endometriosis

Dynamic ultrasonography can be a significant part of a nonlaparoscopic, presumptive diagnosis of endometriosis when there is no obvious ovarian endometrioma.⁵ The evidence for this comes from a classic paper by Okaro and colleagues, “The use of ultrasound‐based ‘soft markers’ for the prediction of pelvic pathology in women with chronic pelvic pain–can we reduce the need for laparoscopy?”⁶ In that study, 120 consecutive women with chronic pelvic pain scheduled for laparoscopy underwent vaginal ultrasonography. Hard markers were defined as structural abnormalities, such as classic endometriomas or hydrosalpinges.

These markers demonstrated a 100% correlation (24 of 24 women) with laparoscopic findings, as one might have suspected. In addition, soft markers (VIDEOS 6A–6C) were defined as reduced ovarian mobility, site-specific pelvic tenderness, and the presence of loculated peritoneal fluid in the pelvis. These were predictive of pelvic pathology in 73% of these women (37 of 51).⁶

Thus, women who have soft markers on dynamic scanning but no obvious anatomic abnormalities can be treated with a high degree of sensitivity without the need for laparoscopic intervention.

Pelvic organ prolapse and incontinence

With the vaginal probe in place, and even a small amount of urine in the bladder, the patient can be asked to bear down (Valsalva maneuver), and cystocele (VIDEO 7) and/or hypermobility of the urethra (VIDEO 8) is easily discerned with dynamic ultrasonography. This information is not available on static anatomic imaging.

A tool that enhances patient care

Dynamic ultrasonography is an important and emerging topic in gynecologic imaging. Static images and even cine clips will yield only anatomic information. Increasingly, whoever holds the transducer—whether it be the gynecologist, radiologist, or sonographer—needs to examine the patient with the probe and include liberal use of the abdominal hand as well. Incorporating this concept will enhance the overall diagnostic input of ultrasound scanning, not just imaging, into better and more accurate patient care. ●

Ultrasonography truly has revolutionized the practice of obstetrics and gynecology. Initially, transabdominal ultrasonography was mainly a tool of the obstetrician. Early linear array, real-time equipment had barely enough resolution to perform very limited assessments, such as measure biparietal diameter and identify vertex versus breech presentation, and anterior versus posterior placenta location. The introduction of transvaginal probes, which employ higher frequency and provide closer proximity to structures, yielded a degree of image magnification that was dubbed sonomicroscopy.¹ In other words, we are seeing things with our naked eye that we could not see if we could hold them in our hand at arm’s length and squint at them. An example of this is the cardiac activity clearly visible in a 3-mm embryo at 45 days from the last menstrual period. One would not appreciate this without the low power magnification of the vaginal probe.

The concept of dynamic imaging

As early as 1990, I realized that there is a difference between an ultrasound “examination” performed because of referral for imaging, which generated a report back to the referring health care provider, and “examining” one’s own patient with ultrasonography at the time of bimanual exam. I coined the phrase “the ultrasound-enhanced bimanual exam,” and I believed it should become a routine part of gynecologic care. I put forth this thesis in an article entitled, “Incorporating endovaginal ultrasonography into the overall gynecologic examination.”² The idea is based on thinking: What exactly are we are trying to discern from a bimanual exam?

Clinicians perform the bimanual exam thousands of times. The bimanual examination consists of 2 components, an objective portion and a subjective portion. The objective component attempts to discern information that is totally objective, such as, Is the ovary enlarged? If so, is it cystic or solid? Is this uterus normal in shape and contour? If so, does it feel like leiomyomas or is it globularly enlarged as with adenomyosis? The subjective component of the bimanual examination attempts to determine whether or not tenderness is present or if there is normal mobility of the pelvic organs.

The objective component can be replaced by an image in very little time if the examiner has the equipment and the knowledge and skill. The subjective component, however, depends on the experience and often the nuance of the examiner. That was my original thought process. I wanted, and still want, the examining clinician to use imaging as part of the overall exam. But now, I want the imager to use examination as part of the overall imaging. (VIDEOS 1A and 1B.) This is the concept of dynamic imaging. It involves the liberal use of the abdominal hand as well as an in-and-out motion of the vaginal probe to ascertain aspects of the examination that in the past I deemed “subjective.” Mainly, this involves the aspects of mobility and/or tenderness.

Continue to: Guidelines concerning pelvic ultrasound do not consider dynamic imaging...

Guidelines concerning pelvic ultrasound do not consider dynamic imaging

Until now, most imagers take a myriad of pictures, mostly still snapshots, to illustrate anatomy. Most imaging physicians then look at a series of such pictures and may never even hold the transducer. This is increasingly true in instances of remote teleradiology. Even for the minority of imagers who utilize video clips (VIDEOS 2A–2C), these are still representations of anatomy .

One need look no further than the guidelines that underpin the expectation of those who scan the female pelvis. The American Institute of Ultrasound in Medicine (AIUM) published a practice parameter for the performance of ultrasonography of the female pelvis, developed in collaboration with the American College of Radiology, American College of Obstetricians and Gynecologists, Society for Pediatric Radiology, and Society of Radiologists in Ultrasound. ³ Nowhere does this document mention anything other than what images to obtain, where to look, and how to measure. Nowhere is there any mention of dynamic imaging—the concept of using one’s other hand on the abdomen, eliciting pain with the vaginal probe, checking for mobility, asking the patient to bear down. The document lists indications for pelvic sonography that include but are not limited to 19 different indications, such as pelvic pain, evaluation of dysmenorrhea, evaluation for signs or symptoms of pelvic infection, and evaluation of incontinence or pelvic organ prolapse (TABLE). ³

Dynamic ultrasonography can aid in the diagnosis of certain conditions

Specifically, what can dynamic ultrasonography add to anatomic imaging? The main considerations are pain, adhesions, endometriosis, and pelvic organ prolapse.

Pelvic pain or tenderness

How can you evaluate a patient’s pelvic pain with an anatomic image? Perhaps pain can be corroborated if there is a classic ovarian endometrioma (FIGURE 1) (VIDEOS 3A, 3B) or classic hydrosalpinx (FIGURE 2) (VIDEOS 4A–4C). But can we evaluate pelvic pain with only an anatomic image? No, absolutely not. Evaluating pain requires dynamic assessment. As described above, in a dynamic ultrasound assessment, liberal use of the abdominal hand and the tip of the vaginal probe can elicit where the patient’s pain exists and whether the pain can be recreated.

Adhesions

Pelvic adhesions can be a significant source of pelvic pain and, also, sometimes infertility. The adhesions themselves may not be visible on anatomic imaging. This is where the concept of the sliding organ sign is paramount, a concept first described by Dr. Ilan Timor-Tritsch in his book Transvaginal Sonography . ⁴ He stated, “Diagnosis of pelvic adhesions becomes possible by the ‘sliding organ sign.’ The transducer tip is pointed at the uterus, ovaries or any pelvic finding, and a gentle push-pull movement of several centimeters is started. If no adhesions are present, the organs will move freely in the pelvis. This displacement of organs is perceived on the screen as a sliding movement.” ⁴ Thus, if structures are in fact adherent, they will move in tandem with each other as evidenced by this dynamic assessment. If they are not adherent, they will move slightly but independently of each other ( VIDEOS 5A–5G ).

Continue to: Endometriosis...

Endometriosis

Dynamic ultrasonography can be a significant part of a nonlaparoscopic, presumptive diagnosis of endometriosis when there is no obvious ovarian endometrioma.⁵ The evidence for this comes from a classic paper by Okaro and colleagues, “The use of ultrasound‐based ‘soft markers’ for the prediction of pelvic pathology in women with chronic pelvic pain–can we reduce the need for laparoscopy?”⁶ In that study, 120 consecutive women with chronic pelvic pain scheduled for laparoscopy underwent vaginal ultrasonography. Hard markers were defined as structural abnormalities, such as classic endometriomas or hydrosalpinges.

These markers demonstrated a 100% correlation (24 of 24 women) with laparoscopic findings, as one might have suspected. In addition, soft markers (VIDEOS 6A–6C) were defined as reduced ovarian mobility, site-specific pelvic tenderness, and the presence of loculated peritoneal fluid in the pelvis. These were predictive of pelvic pathology in 73% of these women (37 of 51).⁶

Thus, women who have soft markers on dynamic scanning but no obvious anatomic abnormalities can be treated with a high degree of sensitivity without the need for laparoscopic intervention.

Pelvic organ prolapse and incontinence

With the vaginal probe in place, and even a small amount of urine in the bladder, the patient can be asked to bear down (Valsalva maneuver), and cystocele (VIDEO 7) and/or hypermobility of the urethra (VIDEO 8) is easily discerned with dynamic ultrasonography. This information is not available on static anatomic imaging.

A tool that enhances patient care

Dynamic ultrasonography is an important and emerging topic in gynecologic imaging. Static images and even cine clips will yield only anatomic information. Increasingly, whoever holds the transducer—whether it be the gynecologist, radiologist, or sonographer—needs to examine the patient with the probe and include liberal use of the abdominal hand as well. Incorporating this concept will enhance the overall diagnostic input of ultrasound scanning, not just imaging, into better and more accurate patient care. ●

Vaginal dryness, encompassed in the modern term genitourinary syndrome of menopause (GSM) affects up to 40% of menopausal women and up to 60% of postmenopausal breast cancer survivors.^1,2 Premenopausal women also can have vulvovaginal dryness while breastfeeding (lactational amenorrhea) and while taking low-dose contraceptives.³ Vaginal moisturizers and lubricants are the first-line treatment options for vaginal dryness, dyspareunia, and GSM.^4,5 In fact, approximately two-thirds of women have reported using a vaginal lubricant in their lifetime.⁶ Despite such ubiquitous use, many health care providers and patients have questions about the difference between vaginal moisturizers and lubricants and how to best choose a product.

Vaginal moisturizers

Vaginal moisturizers are designed to rehydrate the vaginal epithelium. Much like facial or skin moisturizers, they are intended to be applied regularly, every 2 to 3 days, but may be applied more often depending on the severity of symptoms. Vaginal moisturizers work by increasing the fluid content of the vaginal tissue and by lowering the vaginal pH to mimic that of natural vaginal secretions. Vaginal moisturizers are typically water based and use polymers to hydrate tissues.⁷ They change cell morphology but do not change vaginal maturation, indicating that they bring water to the tissue but do not shift the balance between superficial and basal cells and do not increase vaginal epithelial thickness as seen with vaginal estrogen.⁸ Vaginal moisturizers also have been found to be a safe alternative to vaginal estrogen therapy and may improve markers of vaginal health, including vaginal moisture, vaginal fluid volume, vaginal elasticity, and premenopausal pH.⁹ Commercially available vaginal moisturizers have been shown to be as effective as vaginal estrogens in reducing vaginal symptoms such as itching, irritation, and dyspareunia, but some caution should be taken when interpreting these results as neither vaginal moisturizer nor vaginal estrogen tablet were more effective than placebo in a recent randomized controlled trial.^10,11 Small studies on hyaluronic acid have shown efficacy for the treatment of vaginal dryness.^12,13 Hyaluronic acid is commercially available as a vaginal suppository ovule and as a liquid. It may also be obtained from a reliable compounding pharmacy. Vaginal suppository ovules may be a preferable formulation for women who find the liquids messy or cumbersome to apply.

Lubricants

Lubricants differ from vaginal moisturizers because they are specifically designed to be used during intercourse to provide short-term relief from vaginal dryness. They may be water-, silicone-, mineral oil-, or plant oil-based. The use of water- and silicone-based lubricants is associated with high satisfaction for intercourse as well as masturbation.¹⁴ These products may be particularly beneficial to women whose chief complaint is dyspareunia. In fact, women with dyspareunia report more lubricant use than women without dyspareunia, and the most common reason for lubricant use among these women was to reduce or alleviate pain.¹⁵ Overall, women both with and without dyspareunia have a positive perception regarding lubricant use and prefer sexual intercourse that feels more “wet,” and women in their forties have the most positive perception about lubricant use at the time of intercourse compared with other age groups.¹⁶ Furthermore, the World Health Organization (WHO) recommends that condom-compatible lubricants be used with condoms for menopausal and postmenopausal women.¹⁷ Both water-based and silicone-based lubricants may be used with latex condoms, while oil-based lubricants should be avoided as they can degrade the latex condom. While vaginal moisturizers and lubricants technically differ based on use, patients may use one product for both purposes, and some products are marketed as both a moisturizer and lubricant.

Continue to: Providing counsel to patients...

Providing counsel to patients

Patients often seek advice on how to choose vaginal moisturizers and lubricants. Understanding the compositions of these products and their scientific evidence is useful when helping patients make informed decisions regarding their pelvic health. Most commercially available lubricants are either water- or silicone- based. In one study comparing these two types of lubricants, water-based lubricants were associated with fewer genital symptoms than silicone-based products.¹⁴ Women may want to use a natural or organic product and may prefer plant-based oils such as coconut oil or olive oil. Patients should be counseled that latex condoms are not compatible with petroleum-, mineral oil- or plant oil-based lubricants.

In our practice, we generally recommend silicone-based lubricants, as they are readily available and compatible with latex condoms and generally require a smaller amount than water-based lubricants. They tend to be more expensive than water-based lubricants. For vaginal moisturizers, we often recommend commercially available formulations that can be purchased at local pharmacies or drug stores. However, a patient may need to try different lubricants and moisturizers in order to find a preferred product. We have included in TABLES 1 and 2^7,17,18 a list of commercially available vaginal moisturizers and lubricants with ingredient list, pH, osmolality, common formulation, and cost when available, which has been compiled from WHO and published research data to help guide patient counseling. 

The effects of additives

Water-based moisturizers and lubricants may contain many ingredients, such as glycerols, fragrance, flavors, sweeteners, warming or cooling agents, buffering solutions, parabens and other preservatives, and numbing agents. These substances are added to water-based products to prolong water content, alter viscosity, alter pH, achieve certain sensations, and prevent bacterial contamination.⁷ The addition of these substances, however, will alter osmolality and pH balance of the product, which may be of clinical consequence. Silicone- or oil-based products do not contain water and therefore do not have a pH or an osmolality value.

Hyperosmolar formulations can theoretically injure epithelial tissue. In vitro studies have shown that hyperosmotic vaginal products can induce mild to moderate irritation, while very hyperosmolar formulations can induce severe irritation and tissue damage to vaginal epithelial and cervical cells.^19,20 The WHO recommends that the osmolality of a vaginal product not exceed 380 mOsm/kg, but very few commercially available products meet these criteria so, clinically, the threshold is 1,200 mOsm/kg.¹⁷ It should be noted that most commercially available products exceed the 1,200 mOsm/kg threshold. Vaginal products may be a cause for vaginal irritation and should be considered in the differential diagnosis.

The normal vaginal pH is 3.8–4.5, and vaginal products should be pH balanced to this range. The exact role of pH in these products remains poorly understood. Nonetheless, products with a pH of 3 or lower are not recommended.¹⁸ Concerns about osmolality and pH remain theoretical, as a study of 12 commercially available lubricants of varying osmolality and pH found no cytotoxic effect in vivo.¹⁸

Vaginal moisturizers and lubricants contain many inactive ingredients, the most controversial of which are parabens. These substances are used in many cosmetic products as preservatives and are weakly estrogenic. These substances have been found in breast cancer tissue, but their possible role as a carcinogen remains uncertain.^21,22 Nonetheless, the use of paraben-containing products is not recommended for women who have a history of hormonally-driven cancer or who are at high risk for developing cancer.⁷ Many lubricants contain glycerols (glycerol, glycerine, and propylene glycol) to alter viscosity or alter the water properties. The WHO recommends limits on the content of glycerols in these products.¹⁷ Glycerols have been associated with increased risk of bacterial vaginosis (adjusted odds ratio [aOR], 11.75; 95% confidence interval [CI], 1.96–70.27), and can serve as a food source for candida species, possibly increasing risk of yeast infections.^7,23 Additionally, vaginal moisturizers and lubricants may contain preservatives such as chlorhexidine, which can disrupt normal vaginal flora and may cause tissue irritation.⁷

Continue to: Common concerns to be aware of...

Common concerns to be aware of

Women using vaginal products may be concerned about adverse effects, such as worsening vaginal irritation or infection. Vaginal moisturizers have not been shown to have increased risk of adverse effects compared with vaginal estrogens.^9,10 In vitro studies have shown that vaginal moisturizers and lubricants inhibit the growth of Escherichia coli but may also inhibit Lactobacillus crispatus.²⁴ Clinically, vaginal moisturizers have been shown to improve signs of bacterial vaginosis and have even been used to treat bacterial vaginosis.^25,26 A study of commercially available vaginal lubricants inhibited the growth of L crispatus, which may predispose to irritation and infection.²⁷ Nonetheless, the effect of the vaginal products on the vaginal microbiome and vaginal tissue remains poorly studied. Vaginal moisturizers and lubricants, while often helpful for patients, also can potentially cause irritation or predispose to infections. Providers should consider this when evaluating patients for new onset vaginal symptoms after starting vaginal products.

Bottom line

Vaginal products such as moisturizers and lubricants are often effective treatment options for women suffering from genitourinary syndrome of menopause and may be first-line treatment options, especially for women who may wish to avoid estrogen-containing products. Vaginal moisturizers can be recommended to any women experiencing vaginal irritation due to vaginal dryness while vaginal lubricants should be recommended to sexually active women who experience dyspareunia. Clinicians need to be aware of the formulations of these products and possible side effects in order to appropriately counsel patients. ●

Vaginal dryness, encompassed in the modern term genitourinary syndrome of menopause (GSM) affects up to 40% of menopausal women and up to 60% of postmenopausal breast cancer survivors.^1,2 Premenopausal women also can have vulvovaginal dryness while breastfeeding (lactational amenorrhea) and while taking low-dose contraceptives.³ Vaginal moisturizers and lubricants are the first-line treatment options for vaginal dryness, dyspareunia, and GSM.^4,5 In fact, approximately two-thirds of women have reported using a vaginal lubricant in their lifetime.⁶ Despite such ubiquitous use, many health care providers and patients have questions about the difference between vaginal moisturizers and lubricants and how to best choose a product.

Vaginal moisturizers

Vaginal moisturizers are designed to rehydrate the vaginal epithelium. Much like facial or skin moisturizers, they are intended to be applied regularly, every 2 to 3 days, but may be applied more often depending on the severity of symptoms. Vaginal moisturizers work by increasing the fluid content of the vaginal tissue and by lowering the vaginal pH to mimic that of natural vaginal secretions. Vaginal moisturizers are typically water based and use polymers to hydrate tissues.⁷ They change cell morphology but do not change vaginal maturation, indicating that they bring water to the tissue but do not shift the balance between superficial and basal cells and do not increase vaginal epithelial thickness as seen with vaginal estrogen.⁸ Vaginal moisturizers also have been found to be a safe alternative to vaginal estrogen therapy and may improve markers of vaginal health, including vaginal moisture, vaginal fluid volume, vaginal elasticity, and premenopausal pH.⁹ Commercially available vaginal moisturizers have been shown to be as effective as vaginal estrogens in reducing vaginal symptoms such as itching, irritation, and dyspareunia, but some caution should be taken when interpreting these results as neither vaginal moisturizer nor vaginal estrogen tablet were more effective than placebo in a recent randomized controlled trial.^10,11 Small studies on hyaluronic acid have shown efficacy for the treatment of vaginal dryness.^12,13 Hyaluronic acid is commercially available as a vaginal suppository ovule and as a liquid. It may also be obtained from a reliable compounding pharmacy. Vaginal suppository ovules may be a preferable formulation for women who find the liquids messy or cumbersome to apply.

Lubricants

Lubricants differ from vaginal moisturizers because they are specifically designed to be used during intercourse to provide short-term relief from vaginal dryness. They may be water-, silicone-, mineral oil-, or plant oil-based. The use of water- and silicone-based lubricants is associated with high satisfaction for intercourse as well as masturbation.¹⁴ These products may be particularly beneficial to women whose chief complaint is dyspareunia. In fact, women with dyspareunia report more lubricant use than women without dyspareunia, and the most common reason for lubricant use among these women was to reduce or alleviate pain.¹⁵ Overall, women both with and without dyspareunia have a positive perception regarding lubricant use and prefer sexual intercourse that feels more “wet,” and women in their forties have the most positive perception about lubricant use at the time of intercourse compared with other age groups.¹⁶ Furthermore, the World Health Organization (WHO) recommends that condom-compatible lubricants be used with condoms for menopausal and postmenopausal women.¹⁷ Both water-based and silicone-based lubricants may be used with latex condoms, while oil-based lubricants should be avoided as they can degrade the latex condom. While vaginal moisturizers and lubricants technically differ based on use, patients may use one product for both purposes, and some products are marketed as both a moisturizer and lubricant.

Continue to: Providing counsel to patients...

Providing counsel to patients

Patients often seek advice on how to choose vaginal moisturizers and lubricants. Understanding the compositions of these products and their scientific evidence is useful when helping patients make informed decisions regarding their pelvic health. Most commercially available lubricants are either water- or silicone- based. In one study comparing these two types of lubricants, water-based lubricants were associated with fewer genital symptoms than silicone-based products.¹⁴ Women may want to use a natural or organic product and may prefer plant-based oils such as coconut oil or olive oil. Patients should be counseled that latex condoms are not compatible with petroleum-, mineral oil- or plant oil-based lubricants.

In our practice, we generally recommend silicone-based lubricants, as they are readily available and compatible with latex condoms and generally require a smaller amount than water-based lubricants. They tend to be more expensive than water-based lubricants. For vaginal moisturizers, we often recommend commercially available formulations that can be purchased at local pharmacies or drug stores. However, a patient may need to try different lubricants and moisturizers in order to find a preferred product. We have included in TABLES 1 and 2^7,17,18 a list of commercially available vaginal moisturizers and lubricants with ingredient list, pH, osmolality, common formulation, and cost when available, which has been compiled from WHO and published research data to help guide patient counseling. 

The effects of additives

Water-based moisturizers and lubricants may contain many ingredients, such as glycerols, fragrance, flavors, sweeteners, warming or cooling agents, buffering solutions, parabens and other preservatives, and numbing agents. These substances are added to water-based products to prolong water content, alter viscosity, alter pH, achieve certain sensations, and prevent bacterial contamination.⁷ The addition of these substances, however, will alter osmolality and pH balance of the product, which may be of clinical consequence. Silicone- or oil-based products do not contain water and therefore do not have a pH or an osmolality value.

Hyperosmolar formulations can theoretically injure epithelial tissue. In vitro studies have shown that hyperosmotic vaginal products can induce mild to moderate irritation, while very hyperosmolar formulations can induce severe irritation and tissue damage to vaginal epithelial and cervical cells.^19,20 The WHO recommends that the osmolality of a vaginal product not exceed 380 mOsm/kg, but very few commercially available products meet these criteria so, clinically, the threshold is 1,200 mOsm/kg.¹⁷ It should be noted that most commercially available products exceed the 1,200 mOsm/kg threshold. Vaginal products may be a cause for vaginal irritation and should be considered in the differential diagnosis.

The normal vaginal pH is 3.8–4.5, and vaginal products should be pH balanced to this range. The exact role of pH in these products remains poorly understood. Nonetheless, products with a pH of 3 or lower are not recommended.¹⁸ Concerns about osmolality and pH remain theoretical, as a study of 12 commercially available lubricants of varying osmolality and pH found no cytotoxic effect in vivo.¹⁸

Vaginal moisturizers and lubricants contain many inactive ingredients, the most controversial of which are parabens. These substances are used in many cosmetic products as preservatives and are weakly estrogenic. These substances have been found in breast cancer tissue, but their possible role as a carcinogen remains uncertain.^21,22 Nonetheless, the use of paraben-containing products is not recommended for women who have a history of hormonally-driven cancer or who are at high risk for developing cancer.⁷ Many lubricants contain glycerols (glycerol, glycerine, and propylene glycol) to alter viscosity or alter the water properties. The WHO recommends limits on the content of glycerols in these products.¹⁷ Glycerols have been associated with increased risk of bacterial vaginosis (adjusted odds ratio [aOR], 11.75; 95% confidence interval [CI], 1.96–70.27), and can serve as a food source for candida species, possibly increasing risk of yeast infections.^7,23 Additionally, vaginal moisturizers and lubricants may contain preservatives such as chlorhexidine, which can disrupt normal vaginal flora and may cause tissue irritation.⁷

Continue to: Common concerns to be aware of...

Common concerns to be aware of

Women using vaginal products may be concerned about adverse effects, such as worsening vaginal irritation or infection. Vaginal moisturizers have not been shown to have increased risk of adverse effects compared with vaginal estrogens.^9,10 In vitro studies have shown that vaginal moisturizers and lubricants inhibit the growth of Escherichia coli but may also inhibit Lactobacillus crispatus.²⁴ Clinically, vaginal moisturizers have been shown to improve signs of bacterial vaginosis and have even been used to treat bacterial vaginosis.^25,26 A study of commercially available vaginal lubricants inhibited the growth of L crispatus, which may predispose to irritation and infection.²⁷ Nonetheless, the effect of the vaginal products on the vaginal microbiome and vaginal tissue remains poorly studied. Vaginal moisturizers and lubricants, while often helpful for patients, also can potentially cause irritation or predispose to infections. Providers should consider this when evaluating patients for new onset vaginal symptoms after starting vaginal products.

Bottom line

Vaginal products such as moisturizers and lubricants are often effective treatment options for women suffering from genitourinary syndrome of menopause and may be first-line treatment options, especially for women who may wish to avoid estrogen-containing products. Vaginal moisturizers can be recommended to any women experiencing vaginal irritation due to vaginal dryness while vaginal lubricants should be recommended to sexually active women who experience dyspareunia. Clinicians need to be aware of the formulations of these products and possible side effects in order to appropriately counsel patients. ●

Vaginal dryness, encompassed in the modern term genitourinary syndrome of menopause (GSM) affects up to 40% of menopausal women and up to 60% of postmenopausal breast cancer survivors.^1,2 Premenopausal women also can have vulvovaginal dryness while breastfeeding (lactational amenorrhea) and while taking low-dose contraceptives.³ Vaginal moisturizers and lubricants are the first-line treatment options for vaginal dryness, dyspareunia, and GSM.^4,5 In fact, approximately two-thirds of women have reported using a vaginal lubricant in their lifetime.⁶ Despite such ubiquitous use, many health care providers and patients have questions about the difference between vaginal moisturizers and lubricants and how to best choose a product.

Vaginal moisturizers

Vaginal moisturizers are designed to rehydrate the vaginal epithelium. Much like facial or skin moisturizers, they are intended to be applied regularly, every 2 to 3 days, but may be applied more often depending on the severity of symptoms. Vaginal moisturizers work by increasing the fluid content of the vaginal tissue and by lowering the vaginal pH to mimic that of natural vaginal secretions. Vaginal moisturizers are typically water based and use polymers to hydrate tissues.⁷ They change cell morphology but do not change vaginal maturation, indicating that they bring water to the tissue but do not shift the balance between superficial and basal cells and do not increase vaginal epithelial thickness as seen with vaginal estrogen.⁸ Vaginal moisturizers also have been found to be a safe alternative to vaginal estrogen therapy and may improve markers of vaginal health, including vaginal moisture, vaginal fluid volume, vaginal elasticity, and premenopausal pH.⁹ Commercially available vaginal moisturizers have been shown to be as effective as vaginal estrogens in reducing vaginal symptoms such as itching, irritation, and dyspareunia, but some caution should be taken when interpreting these results as neither vaginal moisturizer nor vaginal estrogen tablet were more effective than placebo in a recent randomized controlled trial.^10,11 Small studies on hyaluronic acid have shown efficacy for the treatment of vaginal dryness.^12,13 Hyaluronic acid is commercially available as a vaginal suppository ovule and as a liquid. It may also be obtained from a reliable compounding pharmacy. Vaginal suppository ovules may be a preferable formulation for women who find the liquids messy or cumbersome to apply.

Lubricants

Lubricants differ from vaginal moisturizers because they are specifically designed to be used during intercourse to provide short-term relief from vaginal dryness. They may be water-, silicone-, mineral oil-, or plant oil-based. The use of water- and silicone-based lubricants is associated with high satisfaction for intercourse as well as masturbation.¹⁴ These products may be particularly beneficial to women whose chief complaint is dyspareunia. In fact, women with dyspareunia report more lubricant use than women without dyspareunia, and the most common reason for lubricant use among these women was to reduce or alleviate pain.¹⁵ Overall, women both with and without dyspareunia have a positive perception regarding lubricant use and prefer sexual intercourse that feels more “wet,” and women in their forties have the most positive perception about lubricant use at the time of intercourse compared with other age groups.¹⁶ Furthermore, the World Health Organization (WHO) recommends that condom-compatible lubricants be used with condoms for menopausal and postmenopausal women.¹⁷ Both water-based and silicone-based lubricants may be used with latex condoms, while oil-based lubricants should be avoided as they can degrade the latex condom. While vaginal moisturizers and lubricants technically differ based on use, patients may use one product for both purposes, and some products are marketed as both a moisturizer and lubricant.

Continue to: Providing counsel to patients...

Providing counsel to patients

Patients often seek advice on how to choose vaginal moisturizers and lubricants. Understanding the compositions of these products and their scientific evidence is useful when helping patients make informed decisions regarding their pelvic health. Most commercially available lubricants are either water- or silicone- based. In one study comparing these two types of lubricants, water-based lubricants were associated with fewer genital symptoms than silicone-based products.¹⁴ Women may want to use a natural or organic product and may prefer plant-based oils such as coconut oil or olive oil. Patients should be counseled that latex condoms are not compatible with petroleum-, mineral oil- or plant oil-based lubricants.

In our practice, we generally recommend silicone-based lubricants, as they are readily available and compatible with latex condoms and generally require a smaller amount than water-based lubricants. They tend to be more expensive than water-based lubricants. For vaginal moisturizers, we often recommend commercially available formulations that can be purchased at local pharmacies or drug stores. However, a patient may need to try different lubricants and moisturizers in order to find a preferred product. We have included in TABLES 1 and 2^7,17,18 a list of commercially available vaginal moisturizers and lubricants with ingredient list, pH, osmolality, common formulation, and cost when available, which has been compiled from WHO and published research data to help guide patient counseling. 

The effects of additives

Water-based moisturizers and lubricants may contain many ingredients, such as glycerols, fragrance, flavors, sweeteners, warming or cooling agents, buffering solutions, parabens and other preservatives, and numbing agents. These substances are added to water-based products to prolong water content, alter viscosity, alter pH, achieve certain sensations, and prevent bacterial contamination.⁷ The addition of these substances, however, will alter osmolality and pH balance of the product, which may be of clinical consequence. Silicone- or oil-based products do not contain water and therefore do not have a pH or an osmolality value.

Hyperosmolar formulations can theoretically injure epithelial tissue. In vitro studies have shown that hyperosmotic vaginal products can induce mild to moderate irritation, while very hyperosmolar formulations can induce severe irritation and tissue damage to vaginal epithelial and cervical cells.^19,20 The WHO recommends that the osmolality of a vaginal product not exceed 380 mOsm/kg, but very few commercially available products meet these criteria so, clinically, the threshold is 1,200 mOsm/kg.¹⁷ It should be noted that most commercially available products exceed the 1,200 mOsm/kg threshold. Vaginal products may be a cause for vaginal irritation and should be considered in the differential diagnosis.

The normal vaginal pH is 3.8–4.5, and vaginal products should be pH balanced to this range. The exact role of pH in these products remains poorly understood. Nonetheless, products with a pH of 3 or lower are not recommended.¹⁸ Concerns about osmolality and pH remain theoretical, as a study of 12 commercially available lubricants of varying osmolality and pH found no cytotoxic effect in vivo.¹⁸

Vaginal moisturizers and lubricants contain many inactive ingredients, the most controversial of which are parabens. These substances are used in many cosmetic products as preservatives and are weakly estrogenic. These substances have been found in breast cancer tissue, but their possible role as a carcinogen remains uncertain.^21,22 Nonetheless, the use of paraben-containing products is not recommended for women who have a history of hormonally-driven cancer or who are at high risk for developing cancer.⁷ Many lubricants contain glycerols (glycerol, glycerine, and propylene glycol) to alter viscosity or alter the water properties. The WHO recommends limits on the content of glycerols in these products.¹⁷ Glycerols have been associated with increased risk of bacterial vaginosis (adjusted odds ratio [aOR], 11.75; 95% confidence interval [CI], 1.96–70.27), and can serve as a food source for candida species, possibly increasing risk of yeast infections.^7,23 Additionally, vaginal moisturizers and lubricants may contain preservatives such as chlorhexidine, which can disrupt normal vaginal flora and may cause tissue irritation.⁷

Continue to: Common concerns to be aware of...

Common concerns to be aware of

Women using vaginal products may be concerned about adverse effects, such as worsening vaginal irritation or infection. Vaginal moisturizers have not been shown to have increased risk of adverse effects compared with vaginal estrogens.^9,10 In vitro studies have shown that vaginal moisturizers and lubricants inhibit the growth of Escherichia coli but may also inhibit Lactobacillus crispatus.²⁴ Clinically, vaginal moisturizers have been shown to improve signs of bacterial vaginosis and have even been used to treat bacterial vaginosis.^25,26 A study of commercially available vaginal lubricants inhibited the growth of L crispatus, which may predispose to irritation and infection.²⁷ Nonetheless, the effect of the vaginal products on the vaginal microbiome and vaginal tissue remains poorly studied. Vaginal moisturizers and lubricants, while often helpful for patients, also can potentially cause irritation or predispose to infections. Providers should consider this when evaluating patients for new onset vaginal symptoms after starting vaginal products.

Bottom line

Vaginal products such as moisturizers and lubricants are often effective treatment options for women suffering from genitourinary syndrome of menopause and may be first-line treatment options, especially for women who may wish to avoid estrogen-containing products. Vaginal moisturizers can be recommended to any women experiencing vaginal irritation due to vaginal dryness while vaginal lubricants should be recommended to sexually active women who experience dyspareunia. Clinicians need to be aware of the formulations of these products and possible side effects in order to appropriately counsel patients. ●

Preconception health influences pregnancy outcomes, and in turn, both preconception health and an APO influence adult cardiometabolic health (FIGURE). This editorial is focused on the link between APOs and later cardiometabolic morbidity and mortality, recognizing that preconception health greatly influences the risk of an APO and lifetime cardiometabolic disease.

Adverse pregnancy outcomes

Major APOs include miscarriage, preterm birth (birth <37 weeks’ gestation), low birth weight (birth weight ≤2,500 g; 5.5 lb), gestational diabetes (GDM), preeclampsia, and placental abruption. In the United States, among all births, reported rates of the following APOs are:^1-3

• preterm birth, 10.2%
• low birth weight, 8.3%
• GDM, 6%
• preeclampsia, 5%
• placental abruption, 1%.

Miscarriage occurs in approximately 10% to 15% of pregnancies, influenced by both the age of the woman and the method used to diagnose pregnancy.⁴ Miscarriage, preterm birth, low birth weight, GDM, preeclampsia, and placental abruption have been reported to be associated with an increased risk of later cardiovascular morbidity and mortality.

APOs and cardiovascular disease

Cardiovascular disease (CVD) affects the majority of people past the age of 60 years and includes 4 major subcategories:

1. coronary heart disease, including myocardial infarction, angina, and heart failure
2. CVD, stroke, and transient ischemic attack
3. peripheral artery disease
4. atherosclerosis of the aorta leading to aortic aneurysm.

Multiple meta-analyses report that APOs are associated with CVD in later life. A comprehensive review reported that the risk of CVD was increased following a pregnancy with one of these APOs: severe preeclampsia (odds ratio [OR], 2.74), GDM (OR, 1.68), preterm birth (OR, 1.93), low birth weight (OR, 1.29), and placental abruption (OR, 1.82).⁵

The link between APOs and CVD may be explained in part by the association of APOs with multiple risk factors for CVD, including chronic hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia. A meta-analysis of 43 studies reported that, compared with controls, women with a history of preeclampsia have a 3.13 times greater risk of developing chronic hypertension.⁶ Among women with preeclampsia, approximately 20% will develop hypertension within 15 years.⁷ A meta-analysis of 20 studies reported that women with a history of GDM had a 9.51-times greater risk of developing T2DM than women without GDM.⁸ Among women with a history of GDM, over 16 years of follow-up, T2DM was diagnosed in 16.2%, compared with 1.9% of control women.⁸

CVD prevention—Breastfeeding: An antidote for APOs

Pregnancy stresses both the cardiovascular and metabolic systems. Breastfeeding is an antidote to the stresses imposed by pregnancy. Breastfeeding women have lower blood glucose⁹ and blood pressure.¹⁰

Breastfeeding reduces the risk of CVD. In a study of 100,864 parous Australian women, with a mean age of 60 years, ever breastfeeding was associated a lower risk of CVD hospitalization (adjusted hazard ratio [aHR], 0.86; 95% confidence interval [CI], 0.78–0.96; P = .005) and CVD mortality (aHR, 0.66; 95% CI, 0.49–0.89; P = .006).¹¹
 

Continue to: CVD prevention—American Heart Association recommendations...

CVD prevention—American Heart Association recommendations

The American Heart Association¹² recommends lifestyle interventions to reduce the risk of CVD, including:

• Eat a high-quality diet that includes vegetables, fruit, whole grains, beans, legumes, nuts, plant-based protein, lean animal protein, and fish.
• Limit intake of sugary drinks and foods, fatty or processed meats, full-fat dairy products, eggs, highly processed foods, and tropical oils.
• Exercise at least 150 minutes weekly at a moderate activity level, including muscle-strengthening activity.
• Reduce prolonged intervals of sitting.
• Live a tobacco- and nicotine-free life.
• Strive to maintain a normal body mass index.
• Consider using an activity tracker to monitor activity level.
• After 40 years of age calculate CVD risk using a validated calculator such as the American Cardiology Association risk calculator.¹³ This calculator uses age, gender, and lipid and blood pressure measurements to calculate the 10-year risk of atherosclerotic CVD, including coronary death, myocardial infarction, and stroke.

Medications to reduce CVD risk

Historically, ObGyns have not routinely prescribed medications to treat hypertension, dyslipidemia, or to prevent diabetes. The recent increase in the valuation of return ambulatory visits and a reduction in the valuation assigned to procedural care may provide ObGyn practices the additional resources needed to manage some chronic diseases. Physician assistants and nurse practitioners may help ObGyn practices to manage hypertension, dyslipidemia, and prediabetes.

Prior to initiating a medicine, counseling about healthy living, including smoking cessation, exercise, heart-healthy diet, and achieving an optimal body mass index is warranted.

For treatment of stage II hypertension, defined as blood pressure (BP) measurements with systolic BP ≥140 mm Hg and diastolic BP ≥90 mm Hg, therapeutic lifestyle interventions include: optimizing weight, following the DASH diet, restricting dietary sodium, physical activity, and reducing alcohol consumption. Medication treatment for essential hypertension is guided by the magnitude of BP reduction needed to achieve normotension. For women with hypertension needing antihypertensive medication and planning another pregnancy in the near future, labetalol or extended-release nifedipine may be first-line medications. For women who have completed their families or who have no immediate plans for pregnancy, an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, or thiazide diuretic are commonly prescribed.¹⁴

For the treatment of elevated low-density lipoprotein (LDL) cholesterol in women who have not had a cardiovascular event, statin therapy is often warranted when both the LDL cholesterol is >100 mg/dL and the woman has a calculated 10-year risk of >10% for a cardiovascular event using the American Heart Association or American College of Cardiology calculator. Most women who meet these criteria will be older than age 40 years and many will be under the care of an internal medicine or family medicine specialist, limiting the role of the ObGyn.^15-17

For prevention of diabetes in women with a history of GDM, both weight loss and metformin (1,750 mg daily) have been shown in clinical trials to reduce the risk of developing T2DM.¹⁸ Among 350 women with a history of GDM who were followed for 10 years, metformin 850 mg twice daily reduced the risk of developing T2DM by 40% compared with placebo.¹⁹ In the same study, lifestyle changes without metformin, including loss of 7% of body weight plus 150 minutes of exercise weekly was associated with a 35% reduction in the risk of developing T2DM.¹⁹ Metformin is one of the least expensive prescription medications and is cost-effective for the prevention of T2DM.¹⁸

Low-dose aspirin treatment for the prevention of CVD in women who have not had a cardiovascular event must balance a modest reduction in cardiovascular events with a small increased risk of bleeding events. The US Preventive Services Task Force (USPSTF) recommends low-dose aspirin for a limited group of women, those aged 50 to 59 years of age with a 10-year risk of a cardiovascular event >10% who are willing to take aspirin for 10 years. The USPSTF concluded that there is insufficient evidence to recommend low-dose aspirin prevention of CVD in women aged <50 years.²⁰

Continue to: Beyond the fourth trimester...

Beyond the fourth trimester

The fourth trimester is the 12-week period following birth. At the comprehensive postpartum visit, the American College of Obstetricians and Gynecologists (ACOG) recommends that women with APOs be counseled about their increased lifetime risk of maternal cardiometabolic disease.²¹ In addition, ACOG recommends that at this visit the clinician who will assume primary responsibility for the woman’s ongoing medical care in her primary medical home be clarified. One option is to ensure a high-quality hand-off to an internal medicine or family medicine clinician. Another option is for a clinician in the ObGyn’s office practice, including a physician assistant, nurse practitioner, or office-based ObGyn, to assume some role in the primary care of the woman.

An APO is not only a pregnancy problem

An APO reverberates across a woman’s lifetime, increasing the risk of CVD and diabetes. In the United States the mean age at first birth is 27 years.¹ The mean life expectancy of US women is 81 years.²² Following a birth complicated by an APO there are 5 decades of opportunity to improve health through lifestyle changes and medication treatment of obesity, hypertension, dyslipidemia, and hyperglycemia, thereby reducing the risk of CVD.

Preconception health influences pregnancy outcomes, and in turn, both preconception health and an APO influence adult cardiometabolic health (FIGURE). This editorial is focused on the link between APOs and later cardiometabolic morbidity and mortality, recognizing that preconception health greatly influences the risk of an APO and lifetime cardiometabolic disease.

Adverse pregnancy outcomes

Major APOs include miscarriage, preterm birth (birth <37 weeks’ gestation), low birth weight (birth weight ≤2,500 g; 5.5 lb), gestational diabetes (GDM), preeclampsia, and placental abruption. In the United States, among all births, reported rates of the following APOs are:^1-3

• preterm birth, 10.2%
• low birth weight, 8.3%
• GDM, 6%
• preeclampsia, 5%
• placental abruption, 1%.

Miscarriage occurs in approximately 10% to 15% of pregnancies, influenced by both the age of the woman and the method used to diagnose pregnancy.⁴ Miscarriage, preterm birth, low birth weight, GDM, preeclampsia, and placental abruption have been reported to be associated with an increased risk of later cardiovascular morbidity and mortality.

APOs and cardiovascular disease

Cardiovascular disease (CVD) affects the majority of people past the age of 60 years and includes 4 major subcategories:

1. coronary heart disease, including myocardial infarction, angina, and heart failure
2. CVD, stroke, and transient ischemic attack
3. peripheral artery disease
4. atherosclerosis of the aorta leading to aortic aneurysm.

Multiple meta-analyses report that APOs are associated with CVD in later life. A comprehensive review reported that the risk of CVD was increased following a pregnancy with one of these APOs: severe preeclampsia (odds ratio [OR], 2.74), GDM (OR, 1.68), preterm birth (OR, 1.93), low birth weight (OR, 1.29), and placental abruption (OR, 1.82).⁵

The link between APOs and CVD may be explained in part by the association of APOs with multiple risk factors for CVD, including chronic hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia. A meta-analysis of 43 studies reported that, compared with controls, women with a history of preeclampsia have a 3.13 times greater risk of developing chronic hypertension.⁶ Among women with preeclampsia, approximately 20% will develop hypertension within 15 years.⁷ A meta-analysis of 20 studies reported that women with a history of GDM had a 9.51-times greater risk of developing T2DM than women without GDM.⁸ Among women with a history of GDM, over 16 years of follow-up, T2DM was diagnosed in 16.2%, compared with 1.9% of control women.⁸

CVD prevention—Breastfeeding: An antidote for APOs

Pregnancy stresses both the cardiovascular and metabolic systems. Breastfeeding is an antidote to the stresses imposed by pregnancy. Breastfeeding women have lower blood glucose⁹ and blood pressure.¹⁰

Breastfeeding reduces the risk of CVD. In a study of 100,864 parous Australian women, with a mean age of 60 years, ever breastfeeding was associated a lower risk of CVD hospitalization (adjusted hazard ratio [aHR], 0.86; 95% confidence interval [CI], 0.78–0.96; P = .005) and CVD mortality (aHR, 0.66; 95% CI, 0.49–0.89; P = .006).¹¹
 

Continue to: CVD prevention—American Heart Association recommendations...

CVD prevention—American Heart Association recommendations

The American Heart Association¹² recommends lifestyle interventions to reduce the risk of CVD, including:

• Eat a high-quality diet that includes vegetables, fruit, whole grains, beans, legumes, nuts, plant-based protein, lean animal protein, and fish.
• Limit intake of sugary drinks and foods, fatty or processed meats, full-fat dairy products, eggs, highly processed foods, and tropical oils.
• Exercise at least 150 minutes weekly at a moderate activity level, including muscle-strengthening activity.
• Reduce prolonged intervals of sitting.
• Live a tobacco- and nicotine-free life.
• Strive to maintain a normal body mass index.
• Consider using an activity tracker to monitor activity level.
• After 40 years of age calculate CVD risk using a validated calculator such as the American Cardiology Association risk calculator.¹³ This calculator uses age, gender, and lipid and blood pressure measurements to calculate the 10-year risk of atherosclerotic CVD, including coronary death, myocardial infarction, and stroke.

Medications to reduce CVD risk

Historically, ObGyns have not routinely prescribed medications to treat hypertension, dyslipidemia, or to prevent diabetes. The recent increase in the valuation of return ambulatory visits and a reduction in the valuation assigned to procedural care may provide ObGyn practices the additional resources needed to manage some chronic diseases. Physician assistants and nurse practitioners may help ObGyn practices to manage hypertension, dyslipidemia, and prediabetes.

Prior to initiating a medicine, counseling about healthy living, including smoking cessation, exercise, heart-healthy diet, and achieving an optimal body mass index is warranted.

For treatment of stage II hypertension, defined as blood pressure (BP) measurements with systolic BP ≥140 mm Hg and diastolic BP ≥90 mm Hg, therapeutic lifestyle interventions include: optimizing weight, following the DASH diet, restricting dietary sodium, physical activity, and reducing alcohol consumption. Medication treatment for essential hypertension is guided by the magnitude of BP reduction needed to achieve normotension. For women with hypertension needing antihypertensive medication and planning another pregnancy in the near future, labetalol or extended-release nifedipine may be first-line medications. For women who have completed their families or who have no immediate plans for pregnancy, an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, or thiazide diuretic are commonly prescribed.¹⁴

For the treatment of elevated low-density lipoprotein (LDL) cholesterol in women who have not had a cardiovascular event, statin therapy is often warranted when both the LDL cholesterol is >100 mg/dL and the woman has a calculated 10-year risk of >10% for a cardiovascular event using the American Heart Association or American College of Cardiology calculator. Most women who meet these criteria will be older than age 40 years and many will be under the care of an internal medicine or family medicine specialist, limiting the role of the ObGyn.^15-17

For prevention of diabetes in women with a history of GDM, both weight loss and metformin (1,750 mg daily) have been shown in clinical trials to reduce the risk of developing T2DM.¹⁸ Among 350 women with a history of GDM who were followed for 10 years, metformin 850 mg twice daily reduced the risk of developing T2DM by 40% compared with placebo.¹⁹ In the same study, lifestyle changes without metformin, including loss of 7% of body weight plus 150 minutes of exercise weekly was associated with a 35% reduction in the risk of developing T2DM.¹⁹ Metformin is one of the least expensive prescription medications and is cost-effective for the prevention of T2DM.¹⁸

Low-dose aspirin treatment for the prevention of CVD in women who have not had a cardiovascular event must balance a modest reduction in cardiovascular events with a small increased risk of bleeding events. The US Preventive Services Task Force (USPSTF) recommends low-dose aspirin for a limited group of women, those aged 50 to 59 years of age with a 10-year risk of a cardiovascular event >10% who are willing to take aspirin for 10 years. The USPSTF concluded that there is insufficient evidence to recommend low-dose aspirin prevention of CVD in women aged <50 years.²⁰

Continue to: Beyond the fourth trimester...

Beyond the fourth trimester

The fourth trimester is the 12-week period following birth. At the comprehensive postpartum visit, the American College of Obstetricians and Gynecologists (ACOG) recommends that women with APOs be counseled about their increased lifetime risk of maternal cardiometabolic disease.²¹ In addition, ACOG recommends that at this visit the clinician who will assume primary responsibility for the woman’s ongoing medical care in her primary medical home be clarified. One option is to ensure a high-quality hand-off to an internal medicine or family medicine clinician. Another option is for a clinician in the ObGyn’s office practice, including a physician assistant, nurse practitioner, or office-based ObGyn, to assume some role in the primary care of the woman.

An APO is not only a pregnancy problem

An APO reverberates across a woman’s lifetime, increasing the risk of CVD and diabetes. In the United States the mean age at first birth is 27 years.¹ The mean life expectancy of US women is 81 years.²² Following a birth complicated by an APO there are 5 decades of opportunity to improve health through lifestyle changes and medication treatment of obesity, hypertension, dyslipidemia, and hyperglycemia, thereby reducing the risk of CVD.

Preconception health influences pregnancy outcomes, and in turn, both preconception health and an APO influence adult cardiometabolic health (FIGURE). This editorial is focused on the link between APOs and later cardiometabolic morbidity and mortality, recognizing that preconception health greatly influences the risk of an APO and lifetime cardiometabolic disease.

Adverse pregnancy outcomes

Major APOs include miscarriage, preterm birth (birth <37 weeks’ gestation), low birth weight (birth weight ≤2,500 g; 5.5 lb), gestational diabetes (GDM), preeclampsia, and placental abruption. In the United States, among all births, reported rates of the following APOs are:^1-3

• preterm birth, 10.2%
• low birth weight, 8.3%
• GDM, 6%
• preeclampsia, 5%
• placental abruption, 1%.

Miscarriage occurs in approximately 10% to 15% of pregnancies, influenced by both the age of the woman and the method used to diagnose pregnancy.⁴ Miscarriage, preterm birth, low birth weight, GDM, preeclampsia, and placental abruption have been reported to be associated with an increased risk of later cardiovascular morbidity and mortality.

APOs and cardiovascular disease

Cardiovascular disease (CVD) affects the majority of people past the age of 60 years and includes 4 major subcategories:

1. coronary heart disease, including myocardial infarction, angina, and heart failure
2. CVD, stroke, and transient ischemic attack
3. peripheral artery disease
4. atherosclerosis of the aorta leading to aortic aneurysm.

Multiple meta-analyses report that APOs are associated with CVD in later life. A comprehensive review reported that the risk of CVD was increased following a pregnancy with one of these APOs: severe preeclampsia (odds ratio [OR], 2.74), GDM (OR, 1.68), preterm birth (OR, 1.93), low birth weight (OR, 1.29), and placental abruption (OR, 1.82).⁵

The link between APOs and CVD may be explained in part by the association of APOs with multiple risk factors for CVD, including chronic hypertension, type 2 diabetes mellitus (T2DM), and dyslipidemia. A meta-analysis of 43 studies reported that, compared with controls, women with a history of preeclampsia have a 3.13 times greater risk of developing chronic hypertension.⁶ Among women with preeclampsia, approximately 20% will develop hypertension within 15 years.⁷ A meta-analysis of 20 studies reported that women with a history of GDM had a 9.51-times greater risk of developing T2DM than women without GDM.⁸ Among women with a history of GDM, over 16 years of follow-up, T2DM was diagnosed in 16.2%, compared with 1.9% of control women.⁸

CVD prevention—Breastfeeding: An antidote for APOs

Pregnancy stresses both the cardiovascular and metabolic systems. Breastfeeding is an antidote to the stresses imposed by pregnancy. Breastfeeding women have lower blood glucose⁹ and blood pressure.¹⁰

Breastfeeding reduces the risk of CVD. In a study of 100,864 parous Australian women, with a mean age of 60 years, ever breastfeeding was associated a lower risk of CVD hospitalization (adjusted hazard ratio [aHR], 0.86; 95% confidence interval [CI], 0.78–0.96; P = .005) and CVD mortality (aHR, 0.66; 95% CI, 0.49–0.89; P = .006).¹¹
 

Continue to: CVD prevention—American Heart Association recommendations...

CVD prevention—American Heart Association recommendations

The American Heart Association¹² recommends lifestyle interventions to reduce the risk of CVD, including:

• Eat a high-quality diet that includes vegetables, fruit, whole grains, beans, legumes, nuts, plant-based protein, lean animal protein, and fish.
• Limit intake of sugary drinks and foods, fatty or processed meats, full-fat dairy products, eggs, highly processed foods, and tropical oils.
• Exercise at least 150 minutes weekly at a moderate activity level, including muscle-strengthening activity.
• Reduce prolonged intervals of sitting.
• Live a tobacco- and nicotine-free life.
• Strive to maintain a normal body mass index.
• Consider using an activity tracker to monitor activity level.
• After 40 years of age calculate CVD risk using a validated calculator such as the American Cardiology Association risk calculator.¹³ This calculator uses age, gender, and lipid and blood pressure measurements to calculate the 10-year risk of atherosclerotic CVD, including coronary death, myocardial infarction, and stroke.

Medications to reduce CVD risk

Historically, ObGyns have not routinely prescribed medications to treat hypertension, dyslipidemia, or to prevent diabetes. The recent increase in the valuation of return ambulatory visits and a reduction in the valuation assigned to procedural care may provide ObGyn practices the additional resources needed to manage some chronic diseases. Physician assistants and nurse practitioners may help ObGyn practices to manage hypertension, dyslipidemia, and prediabetes.

Prior to initiating a medicine, counseling about healthy living, including smoking cessation, exercise, heart-healthy diet, and achieving an optimal body mass index is warranted.

For treatment of stage II hypertension, defined as blood pressure (BP) measurements with systolic BP ≥140 mm Hg and diastolic BP ≥90 mm Hg, therapeutic lifestyle interventions include: optimizing weight, following the DASH diet, restricting dietary sodium, physical activity, and reducing alcohol consumption. Medication treatment for essential hypertension is guided by the magnitude of BP reduction needed to achieve normotension. For women with hypertension needing antihypertensive medication and planning another pregnancy in the near future, labetalol or extended-release nifedipine may be first-line medications. For women who have completed their families or who have no immediate plans for pregnancy, an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, or thiazide diuretic are commonly prescribed.¹⁴

For the treatment of elevated low-density lipoprotein (LDL) cholesterol in women who have not had a cardiovascular event, statin therapy is often warranted when both the LDL cholesterol is >100 mg/dL and the woman has a calculated 10-year risk of >10% for a cardiovascular event using the American Heart Association or American College of Cardiology calculator. Most women who meet these criteria will be older than age 40 years and many will be under the care of an internal medicine or family medicine specialist, limiting the role of the ObGyn.^15-17

For prevention of diabetes in women with a history of GDM, both weight loss and metformin (1,750 mg daily) have been shown in clinical trials to reduce the risk of developing T2DM.¹⁸ Among 350 women with a history of GDM who were followed for 10 years, metformin 850 mg twice daily reduced the risk of developing T2DM by 40% compared with placebo.¹⁹ In the same study, lifestyle changes without metformin, including loss of 7% of body weight plus 150 minutes of exercise weekly was associated with a 35% reduction in the risk of developing T2DM.¹⁹ Metformin is one of the least expensive prescription medications and is cost-effective for the prevention of T2DM.¹⁸

Low-dose aspirin treatment for the prevention of CVD in women who have not had a cardiovascular event must balance a modest reduction in cardiovascular events with a small increased risk of bleeding events. The US Preventive Services Task Force (USPSTF) recommends low-dose aspirin for a limited group of women, those aged 50 to 59 years of age with a 10-year risk of a cardiovascular event >10% who are willing to take aspirin for 10 years. The USPSTF concluded that there is insufficient evidence to recommend low-dose aspirin prevention of CVD in women aged <50 years.²⁰

Continue to: Beyond the fourth trimester...

Beyond the fourth trimester

The fourth trimester is the 12-week period following birth. At the comprehensive postpartum visit, the American College of Obstetricians and Gynecologists (ACOG) recommends that women with APOs be counseled about their increased lifetime risk of maternal cardiometabolic disease.²¹ In addition, ACOG recommends that at this visit the clinician who will assume primary responsibility for the woman’s ongoing medical care in her primary medical home be clarified. One option is to ensure a high-quality hand-off to an internal medicine or family medicine clinician. Another option is for a clinician in the ObGyn’s office practice, including a physician assistant, nurse practitioner, or office-based ObGyn, to assume some role in the primary care of the woman.

An APO is not only a pregnancy problem

An APO reverberates across a woman’s lifetime, increasing the risk of CVD and diabetes. In the United States the mean age at first birth is 27 years.¹ The mean life expectancy of US women is 81 years.²² Following a birth complicated by an APO there are 5 decades of opportunity to improve health through lifestyle changes and medication treatment of obesity, hypertension, dyslipidemia, and hyperglycemia, thereby reducing the risk of CVD.

A 2,940-nm and 1,470-nm hybrid fractional laser was found to be safe and effective for treating the genitourinary syndrome of menopause (GSM), results from a pilot trial showed.

“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.

The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.

The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.

“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”

Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.

Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).

Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).

As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)

Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”

Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.

[email protected]

A 2,940-nm and 1,470-nm hybrid fractional laser was found to be safe and effective for treating the genitourinary syndrome of menopause (GSM), results from a pilot trial showed.

“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.

The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.

The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.

“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”

Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.

Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).

Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).

As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)

Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”

Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.

[email protected]

A 2,940-nm and 1,470-nm hybrid fractional laser was found to be safe and effective for treating the genitourinary syndrome of menopause (GSM), results from a pilot trial showed.

“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.

The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.

The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.

“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”

Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.

Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).

Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).

As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)

Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”

Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.

[email protected]

Black women exposed to ozone air pollution have an increased risk of developing fibroids, according to new research published in Human Production.

Uterine fibroids are a common type of pelvic growth, affecting up to 80% of women by the time they reach age 50, according to the U.S. Department of Health and Human Services. Black women are hit hardest by fibroids; they are diagnosed two to three times the rate of White women and tend to have more severe symptoms.

Researchers are unclear on why exposure to ozone air pollution increases the risk of developing fibroids. However, they believe that when it comes to identifying causes of fibroids and explanations for racial disparities in fibroids, more research that focuses on environmental and neighborhood-level risk factors could help inform policy and interventions to improve gynecologic health.

“A large body of literature from the environmental justice field has documented that people of color, and Black people specifically, are inequitably exposed to air pollution,” study author Amelia K. Wesselink, PhD, assistant professor at Boston University School of Public Health, said in an interview. “And there is growing evidence that air pollution can influence gynecologic health and therefore may contribute to racial disparities in gynecologic outcomes.”

Dr. Wesselink and colleagues wanted to know the extent to which three air pollutants – particulate matter (PM2.5), nitrogen dioxide (NO₂) and ozone (0₃) – were linked to the development of fibroids. To figure this out, they analyzed data on nearly 22,000 premenopausal Black women who lived in 56 metropolitan areas in the United States between 2007 and 2011. They assigned air pollution exposures to participants’ residential addresses collected at baseline and over follow-up and tried to capture long-term exposure to air pollutants.

During the study, nearly 30% of participants reported that they were diagnosed with fibroids. Researchers observed that the exposure to PM2.5 and NO₂ was not associated with an increased risk of developing these fibroids.

Dr. Wesselink said the findings may have underestimated fibroid incidence, so they “need to be replicated in a prospective, ultrasound-based study that can identify all fibroid cases.”

“There has not been a lot of research on how air pollution influences fibroid risk, but the two studies that are out there show some evidence of an association,” said Dr. Wesselink. “The fact that our results were consistent with this is interesting. The surprising part of our findings was that we observed an association for ozone, but not for PM2.5 or NO₂.”

Nathaniel DeNicola, MD, MSHP, FACOG, a Washington-based obstetrics and gynecology physician affiliated with John Hopkins Health System, applauded the methodology of the study and said the findings prove that patients and doctors should be talking about the environment and exposures to air pollutants.

“[Air pollution] has numerous components to it. And we should try to figure out exactly what components are most dangerous to human health and what doses and what times of life,” said Dr. DeNicola, an environmental health expert.

The increased risk of developing fibroids is a “historical observation” and air pollution may be part of a multifactorial cause of that, Dr. DeNicola said. He said he wouldn’t be surprised if future studies show that “higher exposure [to air pollution] – due to how city planning works, often communities of color are in the areas with the most dense air pollution – exacerbates some other mechanism already in place.

Although it’s unclear how ozone exposure increases fibroid risk, Dr. Wesselink said it may be through a mechanism that is unique to ozone.

“In other words, it might be that there is a factor related to ozone that we did not account for that explains our findings. Vitamin D is a factor that we were not able to account for in this study,” Dr. Wesselink said. “Future work on this topic should consider the role of vitamin D [exposure or deficiency].”

Dr. DeNicola said ozone’s impact may also be tied to its “known association” with hypertension. A 2017 study by Drew B. Day, PhD, of Duke University, Durham, N.C., and colleagues, found that ozone exposure has been linked to hypertension. Meanwhile, a 2015 study has found an association between hypertension and fibroids.

“[This study] does raise an important message. It shines a light where more research needs to be done,” Dr. DeNicola said. “The ozone connection to hypertension was probably most compelling as a true risk factor for uterine fibroids.”

Dr. Wesselink said future work on fibroid etiology should focus on environmental and neighborhood-level exposures to pollutants.

Black women exposed to ozone air pollution have an increased risk of developing fibroids, according to new research published in Human Production.

Uterine fibroids are a common type of pelvic growth, affecting up to 80% of women by the time they reach age 50, according to the U.S. Department of Health and Human Services. Black women are hit hardest by fibroids; they are diagnosed two to three times the rate of White women and tend to have more severe symptoms.

Researchers are unclear on why exposure to ozone air pollution increases the risk of developing fibroids. However, they believe that when it comes to identifying causes of fibroids and explanations for racial disparities in fibroids, more research that focuses on environmental and neighborhood-level risk factors could help inform policy and interventions to improve gynecologic health.

“A large body of literature from the environmental justice field has documented that people of color, and Black people specifically, are inequitably exposed to air pollution,” study author Amelia K. Wesselink, PhD, assistant professor at Boston University School of Public Health, said in an interview. “And there is growing evidence that air pollution can influence gynecologic health and therefore may contribute to racial disparities in gynecologic outcomes.”

Dr. Wesselink and colleagues wanted to know the extent to which three air pollutants – particulate matter (PM2.5), nitrogen dioxide (NO₂) and ozone (0₃) – were linked to the development of fibroids. To figure this out, they analyzed data on nearly 22,000 premenopausal Black women who lived in 56 metropolitan areas in the United States between 2007 and 2011. They assigned air pollution exposures to participants’ residential addresses collected at baseline and over follow-up and tried to capture long-term exposure to air pollutants.

During the study, nearly 30% of participants reported that they were diagnosed with fibroids. Researchers observed that the exposure to PM2.5 and NO₂ was not associated with an increased risk of developing these fibroids.

Dr. Wesselink said the findings may have underestimated fibroid incidence, so they “need to be replicated in a prospective, ultrasound-based study that can identify all fibroid cases.”

“There has not been a lot of research on how air pollution influences fibroid risk, but the two studies that are out there show some evidence of an association,” said Dr. Wesselink. “The fact that our results were consistent with this is interesting. The surprising part of our findings was that we observed an association for ozone, but not for PM2.5 or NO₂.”

Nathaniel DeNicola, MD, MSHP, FACOG, a Washington-based obstetrics and gynecology physician affiliated with John Hopkins Health System, applauded the methodology of the study and said the findings prove that patients and doctors should be talking about the environment and exposures to air pollutants.

“[Air pollution] has numerous components to it. And we should try to figure out exactly what components are most dangerous to human health and what doses and what times of life,” said Dr. DeNicola, an environmental health expert.

The increased risk of developing fibroids is a “historical observation” and air pollution may be part of a multifactorial cause of that, Dr. DeNicola said. He said he wouldn’t be surprised if future studies show that “higher exposure [to air pollution] – due to how city planning works, often communities of color are in the areas with the most dense air pollution – exacerbates some other mechanism already in place.

Although it’s unclear how ozone exposure increases fibroid risk, Dr. Wesselink said it may be through a mechanism that is unique to ozone.

“In other words, it might be that there is a factor related to ozone that we did not account for that explains our findings. Vitamin D is a factor that we were not able to account for in this study,” Dr. Wesselink said. “Future work on this topic should consider the role of vitamin D [exposure or deficiency].”

Dr. DeNicola said ozone’s impact may also be tied to its “known association” with hypertension. A 2017 study by Drew B. Day, PhD, of Duke University, Durham, N.C., and colleagues, found that ozone exposure has been linked to hypertension. Meanwhile, a 2015 study has found an association between hypertension and fibroids.

“[This study] does raise an important message. It shines a light where more research needs to be done,” Dr. DeNicola said. “The ozone connection to hypertension was probably most compelling as a true risk factor for uterine fibroids.”

Dr. Wesselink said future work on fibroid etiology should focus on environmental and neighborhood-level exposures to pollutants.

Black women exposed to ozone air pollution have an increased risk of developing fibroids, according to new research published in Human Production.

Uterine fibroids are a common type of pelvic growth, affecting up to 80% of women by the time they reach age 50, according to the U.S. Department of Health and Human Services. Black women are hit hardest by fibroids; they are diagnosed two to three times the rate of White women and tend to have more severe symptoms.

Researchers are unclear on why exposure to ozone air pollution increases the risk of developing fibroids. However, they believe that when it comes to identifying causes of fibroids and explanations for racial disparities in fibroids, more research that focuses on environmental and neighborhood-level risk factors could help inform policy and interventions to improve gynecologic health.

“A large body of literature from the environmental justice field has documented that people of color, and Black people specifically, are inequitably exposed to air pollution,” study author Amelia K. Wesselink, PhD, assistant professor at Boston University School of Public Health, said in an interview. “And there is growing evidence that air pollution can influence gynecologic health and therefore may contribute to racial disparities in gynecologic outcomes.”

Dr. Wesselink and colleagues wanted to know the extent to which three air pollutants – particulate matter (PM2.5), nitrogen dioxide (NO₂) and ozone (0₃) – were linked to the development of fibroids. To figure this out, they analyzed data on nearly 22,000 premenopausal Black women who lived in 56 metropolitan areas in the United States between 2007 and 2011. They assigned air pollution exposures to participants’ residential addresses collected at baseline and over follow-up and tried to capture long-term exposure to air pollutants.

During the study, nearly 30% of participants reported that they were diagnosed with fibroids. Researchers observed that the exposure to PM2.5 and NO₂ was not associated with an increased risk of developing these fibroids.

Dr. Wesselink said the findings may have underestimated fibroid incidence, so they “need to be replicated in a prospective, ultrasound-based study that can identify all fibroid cases.”

“There has not been a lot of research on how air pollution influences fibroid risk, but the two studies that are out there show some evidence of an association,” said Dr. Wesselink. “The fact that our results were consistent with this is interesting. The surprising part of our findings was that we observed an association for ozone, but not for PM2.5 or NO₂.”

Nathaniel DeNicola, MD, MSHP, FACOG, a Washington-based obstetrics and gynecology physician affiliated with John Hopkins Health System, applauded the methodology of the study and said the findings prove that patients and doctors should be talking about the environment and exposures to air pollutants.

“[Air pollution] has numerous components to it. And we should try to figure out exactly what components are most dangerous to human health and what doses and what times of life,” said Dr. DeNicola, an environmental health expert.

The increased risk of developing fibroids is a “historical observation” and air pollution may be part of a multifactorial cause of that, Dr. DeNicola said. He said he wouldn’t be surprised if future studies show that “higher exposure [to air pollution] – due to how city planning works, often communities of color are in the areas with the most dense air pollution – exacerbates some other mechanism already in place.

Although it’s unclear how ozone exposure increases fibroid risk, Dr. Wesselink said it may be through a mechanism that is unique to ozone.

“In other words, it might be that there is a factor related to ozone that we did not account for that explains our findings. Vitamin D is a factor that we were not able to account for in this study,” Dr. Wesselink said. “Future work on this topic should consider the role of vitamin D [exposure or deficiency].”

Dr. DeNicola said ozone’s impact may also be tied to its “known association” with hypertension. A 2017 study by Drew B. Day, PhD, of Duke University, Durham, N.C., and colleagues, found that ozone exposure has been linked to hypertension. Meanwhile, a 2015 study has found an association between hypertension and fibroids.

“[This study] does raise an important message. It shines a light where more research needs to be done,” Dr. DeNicola said. “The ozone connection to hypertension was probably most compelling as a true risk factor for uterine fibroids.”

Dr. Wesselink said future work on fibroid etiology should focus on environmental and neighborhood-level exposures to pollutants.

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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