Gynecology

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

Women who use copper IUDs and concurrently use menstrual cups face a higher than expected rate of IUD expulsion, results from a prospective study showed.

Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.

Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.

“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.

According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.

“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”

Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.

SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.

*The article was updated on 4/28/2020.
 

Women who use copper IUDs and concurrently use menstrual cups face a higher than expected rate of IUD expulsion, results from a prospective study showed.

Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.

Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.

“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.

According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.

“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”

Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.

SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.

*The article was updated on 4/28/2020.
 

Women who use copper IUDs and concurrently use menstrual cups face a higher than expected rate of IUD expulsion, results from a prospective study showed.

Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.

Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.

“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.

According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.

“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”

Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.

SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.

*The article was updated on 4/28/2020.
 

In their advocacy column, “OTC hormonal contraception: An important goal in the fight for reproductive justice” (January 2020), Abby L. Schultz, MD, and Megan L. Evans, MD, MPH, discussed a recent committee opinion from the American College of Obstetricians and Gynecologists (ACOG) focused on improving contraception access by offering oral contraceptive pills, progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate over the counter (OTC). The authors agreed with ACOG’s stance and offered several reasons why.

OBG Management polled readers to see their thoughts on the question of whether or not hormonal contraception should be offered OTC.

In their advocacy column, “OTC hormonal contraception: An important goal in the fight for reproductive justice” (January 2020), Abby L. Schultz, MD, and Megan L. Evans, MD, MPH, discussed a recent committee opinion from the American College of Obstetricians and Gynecologists (ACOG) focused on improving contraception access by offering oral contraceptive pills, progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate over the counter (OTC). The authors agreed with ACOG’s stance and offered several reasons why.

OBG Management polled readers to see their thoughts on the question of whether or not hormonal contraception should be offered OTC.

In their advocacy column, “OTC hormonal contraception: An important goal in the fight for reproductive justice” (January 2020), Abby L. Schultz, MD, and Megan L. Evans, MD, MPH, discussed a recent committee opinion from the American College of Obstetricians and Gynecologists (ACOG) focused on improving contraception access by offering oral contraceptive pills, progesterone-only pills, the patch, vaginal rings, and depot medroxyprogesterone acetate over the counter (OTC). The authors agreed with ACOG’s stance and offered several reasons why.

OBG Management polled readers to see their thoughts on the question of whether or not hormonal contraception should be offered OTC.

While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.¹ Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.² Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.³ At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.¹ Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.² Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.³ At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

While often compared with the Spanish influenza contagion of 1918, the current COVID-19 pandemic is arguably unprecedented in scale and scope, global reach, and the rate at which it has spread across the world.
 

Unprecedented times

The United States now has the greatest burden of COVID-19 disease worldwide.¹ Although Boston has thus far been spared the full force of the disease’s impact, it is likely only a matter of time before it reaches here. To prepare for the imminent surge, we at Tufts Medical Center defined 4 short-term strategic imperatives to help guide our COVID-19 preparedness. Having a single unified strategy across our organization has helped to maintain focus and consistency in the messaging amidst all of the uncertainty. Our focus areas are outlined below.
 

1 Flatten the curve

This term refers to the use of “social distancing” and community isolation measures to keep the number of disease cases at a manageable level. COVID-19 is spread almost exclusively through contact with contaminated respiratory droplets. While several categories of risk have been described, the US Centers for Disease Control and Prevention (CDC) defines disease “exposure” as face-to-face contact within 6 feet of an infected individual for more than 15 minutes without wearing a mask.² Intervening at all 3 of these touchpoints effectively reduces transmission. Interventions include limiting in-person meetings, increasing the space between individuals (both providers and patients), and routinely using personal protective equipment (PPE).

Another effective strategy is to divide frontline providers into smaller units or teams to limit cross-contamination: the inpatient team versus the outpatient team, the day team versus the night team, the “on” team versus the “off” team. If the infection lays one team low, other providers can step in until they recover and return to work.

Visitor policies should be developed and strictly implemented. Many institutions do allow one support person in labor and delivery (L&D) regardless of the patient’s COVID-19 status, although that person should not be symptomatic or COVID-19 positive. Whether to test all patients and support persons for COVID-19 on arrival at L&D remains controversial.³ At a minimum, these individuals should be screened for symptoms. Although it was a major focus of initial preventative efforts, taking a travel and exposure history is no longer informative as the virus is now endemic and community spread is common.

Initial preventative efforts focused also on high-risk patients, but routine use of PPE for all encounters clearly is more effective because of the high rate of asymptomatic shedding. The virus can survive suspended in the air for up to 2 hours following an aerosol-generating procedure (AGP) and on surfaces for several hours or even days. Practices such as regular handwashing, cleaning of exposed work surfaces, and avoiding face touching should by now be part of our everyday routine.

Institutions throughout the United States have established inpatient COVID-19 units—so-called “dirty” units—with mixed success. As the pandemic spreads and the number of patients with asymptomatic shedding increases, it is harder to determine who is and who is not infected. Cross-contamination has rendered this approach largely ineffective. Whether this will change with the introduction of rapid point-of-care testing remains to be seen.

Continue to: 2 Preserve PPE...

2 Preserve PPE

PPE use is effective in reducing transmission. This includes tier 1 PPE with or without enhanced droplet precaution (surgical mask, eye protection, gloves, yellow gown) and tier 2 PPE (tier 1 plus N95 respirators or powered air-purifying respirators [PAPR]). Given the acute PPE shortage in many parts of the country, appropriate use of PPE is critical to maintain an adequate supply. For example, tier 2 PPE is required only in the setting of an AGP. This includes intubation and, in our determination, the second stage of labor for COVID-19–positive patients and patients under investigation (PUIs); we do not employ tier 2 PPE for all patients in the second stage of labor, although some hospitals endorse this practice.

Creative solutions to the impending PPE shortage abound, such as the use of 3D printers to make face shields and novel techniques to sterilize and reuse N95 respirators.

3 Create capacity

In the absence of effective treatment for COVID-19 and with a vaccine still many months away, supportive care is critical. The pulmonary sequelae with cytokine storm and acute hypoxemia can come on quickly, require urgent mechanical ventilatory support, and take several weeks to resolve.

Our ability to create inpatient capacity to accommodate ill patients, monitor them closely, and intubate early will likely be the most critical driver of the case fatality rate. This requires deferring outpatient visits (or doing them via telemedicine), expanding intensive care unit capabilities (especially ventilator beds), and canceling elective surgeries. What constitutes “elective surgery” is not always clear. Our institution, for example, regards abortion services as essential and not elective, but this is not the case throughout the United States.

Creating capacity also refers to staffing. Where necessary, providers should be retrained and redeployed. This may require emergency credentialing of providers in areas outside their usual clinical practice and permission may be needed from the Accreditation Council for Graduate Medical Education to engage trainees outside their usual duty hours.
 

4 Support and protect your workforce

Everyone is anxious, and people convey their anxiety in different ways. I have found it helpful to acknowledge those feelings and provide a forum for staff to express and share their anxieties. That said, hospitals are not a democracy. While staff members should be encouraged to ask questions and voice their opinions, everyone is expected to follow protocol regarding patient care.

Celebrating small successes and finding creative ways to alleviate the stress and inject humor can help. Most institutions are using electronic conferencing platforms (such as Zoom or Microsoft Teams) to stay in touch and to continue education initiatives through interactive didactic sessions, grand rounds, morbidity and mortality conferences, and e-journal clubs. These are also a great platform for social events, such as w(h)ine and book clubs and virtual karaoke.

Since many ObGyn providers are women, the closure of day-care centers and schools is particularly challenging. Share best practices among your staff on how to address this problem, such as alternating on-call shifts or matching providers needing day care with ‘furloughed’ college students who are looking to keep busy and make a little money.

Continue to: Avoid overcommunicating...

Avoid overcommunicating

Clear, concise, and timely communication is key. This can be challenging given the rapidly evolving science of COVID-19 and the daily barrage of information from both reliable and unreliable sources. Setting up regular online meetings with your faculty 2 or 3 times per week can keep people informed, promote engagement, and boost morale.

If an urgent e-mail announcement is needed, keep the message focused. Highlight only updated information and changes to existing policies and guidelines. And consider adding a brief anecdote to illustrate the staff’s creativity and resilience: a “best catch” story, for example, or a staff member who started a “commit to sit” program (spending time in the room with patients who want company but are not able to have their family in attendance).
 

Look to the future

COVID-19 will pass. Herd immunity will inevitably develop. The question is how quickly and at what cost. Children delivered today are being born into a society already profoundly altered by COVID-19. Some have started to call them Generation C.

Exactly what life will look like at the back end of this pandemic depends on how effectively we leverage this crisis. There are numerous opportunities to change the way we think about health care and educate the next generation of providers. These include increasing the use of telehealth and remote education, redesigning our traditional prenatal care paradigms, and reinforcing the importance of preventive medicine. This is an opportunity to put the “health” back into “health care.”

Look after yourself

Amid all the chaos and uncertainty, do not forget to take care of yourself and your family. Be calm, be kind, and be flexible. Stay safe.

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

The American College of Obstetricians and Gynecologists (ACOG) posted a useful resource on its website on March 30 for clinicians practicing ambulatory gynecology. The guidance, “COVID-19 FAQs for Obstetrician–Gynecologists, Gynecology” (https://www.acog.org/), is based on expert opinion and is intended to supplement guidance from the Centers for Disease Control and Prevention as well as previously issued ACOG guidance.¹

Which patients need to be seen, and when

The ACOG guidance provides examples of patients needing in-person appointments, video or telephone visits, or for whom deferral of a visit until after the COVID-19 outbreak would be appropriate. Highlights include:

In-person appointments

• suspected ectopic pregnancy
• profuse vaginal bleeding

Video or telephone visits

• contraceptive counseling and prescribing
• management of menopausal symptoms

Deferral of a visit until after the COVID-19 outbreak

• routine well-woman visits for average-risk patients.

Cervical screening

With respect to patients with abnormal cervical cancer screening results, ACOG recommends the ASCCP’s guidance that²:

• for patients with low-grade test results, colposcopy/cervical biopsies be deferred up to 6 to 12 months
• for patients with high-grade results, colposcopy/cervical biopsies be performed within 3 months.

Contraception

Regarding contraceptive services, the ACOG guidance suggests that placement of intrauterine devices (IUDs) and contraceptive implants should continue “where possible.” If initiation of long-acting reversible contraception (LARC) is not feasible, the guidance recommends that use of self-administered contraceptives (including subcutaneous injections, oral, transdermal patch, and vaginal ring contraception) be encouraged as a bridge to later initiation of LARC.

The guidance suggests that removal of IUDs and implants be postponed when possible.

Finally, the guidance suggests that patients with an existing IUD or implant who seek removal and replacement of their contraceptives be counseled regarding extended use of these devices.

Individualize your approach

ACOG emphasizes that no single solution applies to all situations and that each practice or clinic should evaluate the individual situation, including the availability of local and regional resources, staffing, and personal protective equipment; the prevalence of COVID-19 in the region; and the type of practice.

A roadmap for care

This guidance from ACOG should help clinicians caring for women during the COVID-19 outbreak to counsel and guide patients in a prudent manner.
 

STOWE, VT. – Menstrual migraine is more disabling than migraine that has no association with menstruation, said Susan Hutchinson, MD, director of the Orange County Migraine and Headache Center in Irvine, Calif. Compared with headaches associated with nonmenstrual migraine, headaches resulting from menstrual migraine last longer and are more difficult to treat. They tend to be associated with morning awakening and with nausea and vomiting. But in younger women with regular menses, menstrual migraine is predictable. The disorder offers “an incredible chance to be preemptive and think about short-term preventive strategies,” Dr. Hutchinson said at the annual meeting of the Headache Cooperative of New England.

What is menstrual migraine?

Menstrual migraine occurs during the perimenstrual window, which begins at 2 days before onset of bleeding and ends at 3 days of menses. Migraine that occurs during this window at least two-thirds of the time satisfies the criteria for menstrual migraine. A prospective headache diary is recommended, but not required, for making the diagnosis, said Dr. Hutchinson.

Most women with migraine have perimenstrual exacerbation of their headaches, as well as headaches at other times of the month. This phenotype is called menstrually related migraine. Pure menstrual migraine is migraine associated exclusively with menses. The International Classification of Headache Disorders-3 recognizes that menstrual migraine can be with or without aura. A headache diary can help distinguish between menstrual migraine and menstrually related migraine.

For pure menstrual migraine, it is appropriate to treat during the perimenstrual window. Preventive treatment may not be necessary throughout the month, said Dr. Hutchinson. Furthermore, hormonal treatment is the type of therapy most likely to be effective, she added. Menstrually related migraine requires a broader approach.
 

Gathering information during the visit

A 1972 study by Somerville and colleagues indicated that a decrease in estrogen is a powerful trigger of migraine. The investigators administered estrogen (i.e., intramuscular estradiol) or progesterone during the late luteal phase to women with menstrual migraine. Among women who received estrogen, migraine onset was postponed until the estrogen level decreased. The administration of progesterone postponed bleeding, but did not affect migraine. Progesterone treatment prevents migraine effectively on occasion, but estrogen treatment is much more likely to be a successful strategy, said Dr. Hutchinson.

Neurologists should ask certain questions of women with migraine, whether the patients are new or not, to gather information needed to make treatment decisions. For example, it is advisable to ask a woman whether she often has a headache with her period. “You may not want to use the word ‘migraine,’ because many women have been taught that headache is part of PMS,” said Dr. Hutchinson. Asking a woman how pregnancy, delivery, and breastfeeding affected her headaches can add further detail to her history and provide insight about the effects of hormonal changes. Asking what type of birth control the woman is taking can influence the choice of treatment, since some therapies are not appropriate during pregnancy.
 

Available treatments

NSAIDs are among the treatments that neurologists should consider for the short-term prevention of menstrually related migraine, said Dr. Hutchinson. A study of 35 patients by Sances et al. compared placebo with 550 mg of naproxen sodium given twice daily. Treatment began at 7 days before bleeding onset and continued until the 6th day of menses. Patients underwent treatment for three menstrual cycles. Naproxen sodium significantly reduced headache intensity, headache duration, and the number of headache days, compared with baseline. Treatment was superior to placebo at 3 months. Approximately 33% of patients in the active group were headache free, but no controls were.

Magnesium is another potentially effective option. Facchinetti et al. compared placebo with 360 mg/day of magnesium in a study of 20 patients. Treatment, which was given for two cycles, began at 15 days before menses and ended at the start of menses. Compared with placebo, magnesium reduced the number of headache days and the total pain index. Magnesium is inexpensive, but it causes diarrhea in some patients. “Some women choose to take magnesium all month long, other women start at around ovulation,” said Dr. Hutchinson.

Hormonal treatments are another possible option for the short-term prevention of menstrually related migraine. For women who do not plan to become pregnant, oral contraceptive pills can keep estrogen levels high enough to prevent menstrually related migraine. Gynecologists may suggest that a woman take the pill continuously, skipping the placebo, for an entire year, but Dr. Hutchinson recommends that a woman stop taking the pill for 4 days approximately every 3 months. This discontinuation allows for withdrawal bleeding, but is not likely to cause a prolonged enough decrease in estrogen to provoke migraine, she said. The continuous contraceptive ring, which is inserted vaginally, is an alternative to the pill.

For women who do not want or need contraception, an estrogen patch or gel may be appropriate. Two studies in the 1980s found that a gel containing 1.5 mg of estradiol per 2.5 g reduced migraine frequency, duration, and severity. These studies did not gather long-term safety data, however. A 2006 study by MacGregor et al. found that percutaneous estradiol was associated with a 22% reduction in the number of migraine days, as well as with decreases in headache severity and associated nausea. But the risk of migraine during the 5 days following treatment cessation was increased by 40%. This finding suggests that the treatment period should be extended, said Dr. Hutchinson.

In addition to the timing, the dose of treatment affects the outcome. Smite et al. found no benefit of a 50-mcg dose of estradiol, compared with placebo. Pradalier and colleagues found that a 100-mcg dose was associated with decreased use of rescue medication, compared with a 25-mcg dose. These studies did not gather long-term safety data.
 

Oral contraceptives and the risk of stroke

Combined oral contraceptives, however, are associated with increased risk of stroke in women with migraine with aura. The dose of estrogen in the contraceptive affects the level of risk, said Dr. Hutchinson. A systematic review by Sheikh et al. found that high-dose ethinyl estradiol (i.e., greater than 50 mcg) was associated with a higher risk of ischemic and hemorrhagic stroke than low-dose ethinyl estradiol (i.e., less than 50 mcg) was. A 20-mcg dose was associated with an odds ratio of stroke of 1.7. Furthermore, among women using combined hormonal contraception, the risk of stroke was higher in women with aura than in women without aura.

“I like to look at the big picture,” said Dr. Hutchinson. “There’s a big difference between a woman who has one or two auras a year that last for 10 minutes and a woman who has complicated aura. I’m going to approach [the latter] woman differently.”

No consensus guidelines for prescribing combined oral contraceptives to women with migraine and aura have been developed. The International Headache Society says that physicians may prescribe low-dose estrogen to women with simple visual aura. The American College of Obstetricians and Gynecologists recommends progestin-only intrauterine or barrier contraception for this population. The World Health Organization holds that estrogen-containing contraception is contraindicated in all women who have migraine with aura.

“If you have women who have migraine without aura, low–estrogen dose combined hormonal contraceptives can be quite appropriate,” said Dr. Hutchinson. “I would tend to go with a 10- or 20-mcg low dose. It could be an option for women with migraine with aura, but only if the benefits outweigh the risks.” In a study by Calhoun et al., the vaginal ring was associated with reduced aura frequency in women with migraine and aura.
 

Choosing preventive and rescue medications

Although no triptan has FDA approval for the short-term prevention of menstrual migraine, studies have suggested that they are effective. In a study by Sances and colleagues, a twice-daily 1-mg dose of naratriptan taken 6 days perimenstrually reduced the frequency of menstrual-related migraine. At least 50% of treated patients in the study had no menstrual-related migraine. Silberstein and colleagues found that 59% of women who took 2.5 mg of frovatriptan twice daily had no menstrual-related migraine during the 6-day perimenstrual period, compared with 33% of women who received placebo.

Patients with menstrual migraine sometimes need rescue medication. Sumatriptan, either as an injection or an inhaled therapy, is one option. Another injectable option is a 60-mg intramuscular dose of ketorolac. Finally, occipital or sphenopalatine nerve block may be effective as well.

Dr. Hutchinson reported consulting for or serving on the advisory board of Alder, Allergan, Amgen, Biohaven, electroCore, Lilly, Novartis, Supernus, Teva, Theranica, and Upsher-Smith. She has served on speakers bureaus for Allergan, Amgen, electroCore, Lilly, Novartis, Supernus, and Teva.

[email protected]

STOWE, VT. – Menstrual migraine is more disabling than migraine that has no association with menstruation, said Susan Hutchinson, MD, director of the Orange County Migraine and Headache Center in Irvine, Calif. Compared with headaches associated with nonmenstrual migraine, headaches resulting from menstrual migraine last longer and are more difficult to treat. They tend to be associated with morning awakening and with nausea and vomiting. But in younger women with regular menses, menstrual migraine is predictable. The disorder offers “an incredible chance to be preemptive and think about short-term preventive strategies,” Dr. Hutchinson said at the annual meeting of the Headache Cooperative of New England.

What is menstrual migraine?

Menstrual migraine occurs during the perimenstrual window, which begins at 2 days before onset of bleeding and ends at 3 days of menses. Migraine that occurs during this window at least two-thirds of the time satisfies the criteria for menstrual migraine. A prospective headache diary is recommended, but not required, for making the diagnosis, said Dr. Hutchinson.

Most women with migraine have perimenstrual exacerbation of their headaches, as well as headaches at other times of the month. This phenotype is called menstrually related migraine. Pure menstrual migraine is migraine associated exclusively with menses. The International Classification of Headache Disorders-3 recognizes that menstrual migraine can be with or without aura. A headache diary can help distinguish between menstrual migraine and menstrually related migraine.

For pure menstrual migraine, it is appropriate to treat during the perimenstrual window. Preventive treatment may not be necessary throughout the month, said Dr. Hutchinson. Furthermore, hormonal treatment is the type of therapy most likely to be effective, she added. Menstrually related migraine requires a broader approach.
 

Gathering information during the visit

A 1972 study by Somerville and colleagues indicated that a decrease in estrogen is a powerful trigger of migraine. The investigators administered estrogen (i.e., intramuscular estradiol) or progesterone during the late luteal phase to women with menstrual migraine. Among women who received estrogen, migraine onset was postponed until the estrogen level decreased. The administration of progesterone postponed bleeding, but did not affect migraine. Progesterone treatment prevents migraine effectively on occasion, but estrogen treatment is much more likely to be a successful strategy, said Dr. Hutchinson.

Neurologists should ask certain questions of women with migraine, whether the patients are new or not, to gather information needed to make treatment decisions. For example, it is advisable to ask a woman whether she often has a headache with her period. “You may not want to use the word ‘migraine,’ because many women have been taught that headache is part of PMS,” said Dr. Hutchinson. Asking a woman how pregnancy, delivery, and breastfeeding affected her headaches can add further detail to her history and provide insight about the effects of hormonal changes. Asking what type of birth control the woman is taking can influence the choice of treatment, since some therapies are not appropriate during pregnancy.
 

Available treatments

NSAIDs are among the treatments that neurologists should consider for the short-term prevention of menstrually related migraine, said Dr. Hutchinson. A study of 35 patients by Sances et al. compared placebo with 550 mg of naproxen sodium given twice daily. Treatment began at 7 days before bleeding onset and continued until the 6th day of menses. Patients underwent treatment for three menstrual cycles. Naproxen sodium significantly reduced headache intensity, headache duration, and the number of headache days, compared with baseline. Treatment was superior to placebo at 3 months. Approximately 33% of patients in the active group were headache free, but no controls were.

Magnesium is another potentially effective option. Facchinetti et al. compared placebo with 360 mg/day of magnesium in a study of 20 patients. Treatment, which was given for two cycles, began at 15 days before menses and ended at the start of menses. Compared with placebo, magnesium reduced the number of headache days and the total pain index. Magnesium is inexpensive, but it causes diarrhea in some patients. “Some women choose to take magnesium all month long, other women start at around ovulation,” said Dr. Hutchinson.

Hormonal treatments are another possible option for the short-term prevention of menstrually related migraine. For women who do not plan to become pregnant, oral contraceptive pills can keep estrogen levels high enough to prevent menstrually related migraine. Gynecologists may suggest that a woman take the pill continuously, skipping the placebo, for an entire year, but Dr. Hutchinson recommends that a woman stop taking the pill for 4 days approximately every 3 months. This discontinuation allows for withdrawal bleeding, but is not likely to cause a prolonged enough decrease in estrogen to provoke migraine, she said. The continuous contraceptive ring, which is inserted vaginally, is an alternative to the pill.

For women who do not want or need contraception, an estrogen patch or gel may be appropriate. Two studies in the 1980s found that a gel containing 1.5 mg of estradiol per 2.5 g reduced migraine frequency, duration, and severity. These studies did not gather long-term safety data, however. A 2006 study by MacGregor et al. found that percutaneous estradiol was associated with a 22% reduction in the number of migraine days, as well as with decreases in headache severity and associated nausea. But the risk of migraine during the 5 days following treatment cessation was increased by 40%. This finding suggests that the treatment period should be extended, said Dr. Hutchinson.

In addition to the timing, the dose of treatment affects the outcome. Smite et al. found no benefit of a 50-mcg dose of estradiol, compared with placebo. Pradalier and colleagues found that a 100-mcg dose was associated with decreased use of rescue medication, compared with a 25-mcg dose. These studies did not gather long-term safety data.
 

Oral contraceptives and the risk of stroke

Combined oral contraceptives, however, are associated with increased risk of stroke in women with migraine with aura. The dose of estrogen in the contraceptive affects the level of risk, said Dr. Hutchinson. A systematic review by Sheikh et al. found that high-dose ethinyl estradiol (i.e., greater than 50 mcg) was associated with a higher risk of ischemic and hemorrhagic stroke than low-dose ethinyl estradiol (i.e., less than 50 mcg) was. A 20-mcg dose was associated with an odds ratio of stroke of 1.7. Furthermore, among women using combined hormonal contraception, the risk of stroke was higher in women with aura than in women without aura.

“I like to look at the big picture,” said Dr. Hutchinson. “There’s a big difference between a woman who has one or two auras a year that last for 10 minutes and a woman who has complicated aura. I’m going to approach [the latter] woman differently.”

No consensus guidelines for prescribing combined oral contraceptives to women with migraine and aura have been developed. The International Headache Society says that physicians may prescribe low-dose estrogen to women with simple visual aura. The American College of Obstetricians and Gynecologists recommends progestin-only intrauterine or barrier contraception for this population. The World Health Organization holds that estrogen-containing contraception is contraindicated in all women who have migraine with aura.

“If you have women who have migraine without aura, low–estrogen dose combined hormonal contraceptives can be quite appropriate,” said Dr. Hutchinson. “I would tend to go with a 10- or 20-mcg low dose. It could be an option for women with migraine with aura, but only if the benefits outweigh the risks.” In a study by Calhoun et al., the vaginal ring was associated with reduced aura frequency in women with migraine and aura.
 

Choosing preventive and rescue medications

Although no triptan has FDA approval for the short-term prevention of menstrual migraine, studies have suggested that they are effective. In a study by Sances and colleagues, a twice-daily 1-mg dose of naratriptan taken 6 days perimenstrually reduced the frequency of menstrual-related migraine. At least 50% of treated patients in the study had no menstrual-related migraine. Silberstein and colleagues found that 59% of women who took 2.5 mg of frovatriptan twice daily had no menstrual-related migraine during the 6-day perimenstrual period, compared with 33% of women who received placebo.

Patients with menstrual migraine sometimes need rescue medication. Sumatriptan, either as an injection or an inhaled therapy, is one option. Another injectable option is a 60-mg intramuscular dose of ketorolac. Finally, occipital or sphenopalatine nerve block may be effective as well.

Dr. Hutchinson reported consulting for or serving on the advisory board of Alder, Allergan, Amgen, Biohaven, electroCore, Lilly, Novartis, Supernus, Teva, Theranica, and Upsher-Smith. She has served on speakers bureaus for Allergan, Amgen, electroCore, Lilly, Novartis, Supernus, and Teva.

[email protected]

STOWE, VT. – Menstrual migraine is more disabling than migraine that has no association with menstruation, said Susan Hutchinson, MD, director of the Orange County Migraine and Headache Center in Irvine, Calif. Compared with headaches associated with nonmenstrual migraine, headaches resulting from menstrual migraine last longer and are more difficult to treat. They tend to be associated with morning awakening and with nausea and vomiting. But in younger women with regular menses, menstrual migraine is predictable. The disorder offers “an incredible chance to be preemptive and think about short-term preventive strategies,” Dr. Hutchinson said at the annual meeting of the Headache Cooperative of New England.

What is menstrual migraine?

Menstrual migraine occurs during the perimenstrual window, which begins at 2 days before onset of bleeding and ends at 3 days of menses. Migraine that occurs during this window at least two-thirds of the time satisfies the criteria for menstrual migraine. A prospective headache diary is recommended, but not required, for making the diagnosis, said Dr. Hutchinson.

Most women with migraine have perimenstrual exacerbation of their headaches, as well as headaches at other times of the month. This phenotype is called menstrually related migraine. Pure menstrual migraine is migraine associated exclusively with menses. The International Classification of Headache Disorders-3 recognizes that menstrual migraine can be with or without aura. A headache diary can help distinguish between menstrual migraine and menstrually related migraine.

For pure menstrual migraine, it is appropriate to treat during the perimenstrual window. Preventive treatment may not be necessary throughout the month, said Dr. Hutchinson. Furthermore, hormonal treatment is the type of therapy most likely to be effective, she added. Menstrually related migraine requires a broader approach.
 

Gathering information during the visit

A 1972 study by Somerville and colleagues indicated that a decrease in estrogen is a powerful trigger of migraine. The investigators administered estrogen (i.e., intramuscular estradiol) or progesterone during the late luteal phase to women with menstrual migraine. Among women who received estrogen, migraine onset was postponed until the estrogen level decreased. The administration of progesterone postponed bleeding, but did not affect migraine. Progesterone treatment prevents migraine effectively on occasion, but estrogen treatment is much more likely to be a successful strategy, said Dr. Hutchinson.

Neurologists should ask certain questions of women with migraine, whether the patients are new or not, to gather information needed to make treatment decisions. For example, it is advisable to ask a woman whether she often has a headache with her period. “You may not want to use the word ‘migraine,’ because many women have been taught that headache is part of PMS,” said Dr. Hutchinson. Asking a woman how pregnancy, delivery, and breastfeeding affected her headaches can add further detail to her history and provide insight about the effects of hormonal changes. Asking what type of birth control the woman is taking can influence the choice of treatment, since some therapies are not appropriate during pregnancy.
 

Available treatments

NSAIDs are among the treatments that neurologists should consider for the short-term prevention of menstrually related migraine, said Dr. Hutchinson. A study of 35 patients by Sances et al. compared placebo with 550 mg of naproxen sodium given twice daily. Treatment began at 7 days before bleeding onset and continued until the 6th day of menses. Patients underwent treatment for three menstrual cycles. Naproxen sodium significantly reduced headache intensity, headache duration, and the number of headache days, compared with baseline. Treatment was superior to placebo at 3 months. Approximately 33% of patients in the active group were headache free, but no controls were.

Magnesium is another potentially effective option. Facchinetti et al. compared placebo with 360 mg/day of magnesium in a study of 20 patients. Treatment, which was given for two cycles, began at 15 days before menses and ended at the start of menses. Compared with placebo, magnesium reduced the number of headache days and the total pain index. Magnesium is inexpensive, but it causes diarrhea in some patients. “Some women choose to take magnesium all month long, other women start at around ovulation,” said Dr. Hutchinson.

Hormonal treatments are another possible option for the short-term prevention of menstrually related migraine. For women who do not plan to become pregnant, oral contraceptive pills can keep estrogen levels high enough to prevent menstrually related migraine. Gynecologists may suggest that a woman take the pill continuously, skipping the placebo, for an entire year, but Dr. Hutchinson recommends that a woman stop taking the pill for 4 days approximately every 3 months. This discontinuation allows for withdrawal bleeding, but is not likely to cause a prolonged enough decrease in estrogen to provoke migraine, she said. The continuous contraceptive ring, which is inserted vaginally, is an alternative to the pill.

For women who do not want or need contraception, an estrogen patch or gel may be appropriate. Two studies in the 1980s found that a gel containing 1.5 mg of estradiol per 2.5 g reduced migraine frequency, duration, and severity. These studies did not gather long-term safety data, however. A 2006 study by MacGregor et al. found that percutaneous estradiol was associated with a 22% reduction in the number of migraine days, as well as with decreases in headache severity and associated nausea. But the risk of migraine during the 5 days following treatment cessation was increased by 40%. This finding suggests that the treatment period should be extended, said Dr. Hutchinson.

In addition to the timing, the dose of treatment affects the outcome. Smite et al. found no benefit of a 50-mcg dose of estradiol, compared with placebo. Pradalier and colleagues found that a 100-mcg dose was associated with decreased use of rescue medication, compared with a 25-mcg dose. These studies did not gather long-term safety data.
 

Oral contraceptives and the risk of stroke

Combined oral contraceptives, however, are associated with increased risk of stroke in women with migraine with aura. The dose of estrogen in the contraceptive affects the level of risk, said Dr. Hutchinson. A systematic review by Sheikh et al. found that high-dose ethinyl estradiol (i.e., greater than 50 mcg) was associated with a higher risk of ischemic and hemorrhagic stroke than low-dose ethinyl estradiol (i.e., less than 50 mcg) was. A 20-mcg dose was associated with an odds ratio of stroke of 1.7. Furthermore, among women using combined hormonal contraception, the risk of stroke was higher in women with aura than in women without aura.

“I like to look at the big picture,” said Dr. Hutchinson. “There’s a big difference between a woman who has one or two auras a year that last for 10 minutes and a woman who has complicated aura. I’m going to approach [the latter] woman differently.”

No consensus guidelines for prescribing combined oral contraceptives to women with migraine and aura have been developed. The International Headache Society says that physicians may prescribe low-dose estrogen to women with simple visual aura. The American College of Obstetricians and Gynecologists recommends progestin-only intrauterine or barrier contraception for this population. The World Health Organization holds that estrogen-containing contraception is contraindicated in all women who have migraine with aura.

“If you have women who have migraine without aura, low–estrogen dose combined hormonal contraceptives can be quite appropriate,” said Dr. Hutchinson. “I would tend to go with a 10- or 20-mcg low dose. It could be an option for women with migraine with aura, but only if the benefits outweigh the risks.” In a study by Calhoun et al., the vaginal ring was associated with reduced aura frequency in women with migraine and aura.
 

Choosing preventive and rescue medications

Although no triptan has FDA approval for the short-term prevention of menstrual migraine, studies have suggested that they are effective. In a study by Sances and colleagues, a twice-daily 1-mg dose of naratriptan taken 6 days perimenstrually reduced the frequency of menstrual-related migraine. At least 50% of treated patients in the study had no menstrual-related migraine. Silberstein and colleagues found that 59% of women who took 2.5 mg of frovatriptan twice daily had no menstrual-related migraine during the 6-day perimenstrual period, compared with 33% of women who received placebo.

Patients with menstrual migraine sometimes need rescue medication. Sumatriptan, either as an injection or an inhaled therapy, is one option. Another injectable option is a 60-mg intramuscular dose of ketorolac. Finally, occipital or sphenopalatine nerve block may be effective as well.

Dr. Hutchinson reported consulting for or serving on the advisory board of Alder, Allergan, Amgen, Biohaven, electroCore, Lilly, Novartis, Supernus, Teva, Theranica, and Upsher-Smith. She has served on speakers bureaus for Allergan, Amgen, electroCore, Lilly, Novartis, Supernus, and Teva.

[email protected]

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.¹

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.¹

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Expert Commentary

Any women’s health care provider is extremely aware of how common uterine fibroids (leiomyomas) are in reproductive-aged women. Bleeding associated with such fibroids is a common source of medical morbidity and reduced quality of life for many patients. The mainstay treatment approach for such patients has been surgical, which over time has become minimally invasive. Finding a nonsurgical treatment for patients with fibroid-associated HMB is of huge importance. The recent failure of the selective progesterone receptor modulator ulipristal acetate to be approved by the US Food and Drug Administration (FDA) was a significant setback to finding an excellent option for medical management. A gonadotropin-releasing hormone (GnRH) antagonist like elagolix could become an incredibly important “arrow in the quiver” of women’s health clinicians.

Details about elagolix

As mentioned, elagolix was FDA approved in 2-dose regimens for the treatment of dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia associated with endometriosis. One would expect that such a GnRH antagonist would reduce or eliminate HMB in patients with fibroids, although formal study had never been undertaken. Previous studies of elagolix had shown the most common adverse reaction to be vasomotor symptoms—hot flashes and night sweats. In addition, the drug shows a dose-dependent decrease in bone mineral density (BMD), although its effect on long-term bone health and future fracture risk is unknown.¹

Study specifics. The current study by Schlaff and colleagues was performed including 3 arms: a placebo arm, an elagolix 300 mg twice daily arm, and a third arm that received elagolix 300 mg twice daily and hormonal “add-back” therapy in the form of estradiol 1 mg and norethindrone acetate 0.5 mg daily. The authors actually report on two phase 3 six-month trials that were identical, double-blind, and randomized in nature. Both trials involved approximately 400 women. About 70% of the study participants overall were black, and the average age was approximately 42 years (range, 18 to 51). At baseline, BMD scores were mostly in the normal range. HMB for inclusion was defined as a volume of more than 80 mL per month.

The primary end point was menstrual blood loss volume less than 80 mL in the final month and at least a 50% reduction in menstrual blood loss from baseline to the final month. In the placebo group, only 9% and 10%, respectively, met these criteria.

Continue to: Results...

Results. In the first study group, 84% of those receiving elagolix alone achieved the primary end point, while the group that received elagolix plus add-back therapy had 69% success.

In the second study, both the elagolix group and the add-back group showed that 77% of patients met the primary end point criteria.

The incidences of hot flashes in the elagolix-alone groups were 64% and 43%, respectively, while with add-back therapy, they were 20% in both trials. In the placebo groups, 9% and 4% of participants reported hot flashes. At 6 months, the elagolix-only groups in both trials lost more BMD than the placebo groups, while BMD loss in both add-back groups was not statistically significant from the placebo groups.

Study strengths

Schlaff and colleagues conducted a very well-designed study. The two phase 3 clinical trials in preparation for drug approval were thorough and well reported. The authors are to be commended for including nearly 70% black women as study participants, since this is a racial group known to be affected by HMB resulting from fibroids.

Another strength was the addition of add-back therapy to the doses of elagolix. Concerns about bone loss from a health perspective and vasomotor symptoms from a quality-of-life perspective are not insignificant with elagolix-alone treatment, and proof that add-back therapy significantly diminishes or attenuates the efficacy of this entity is extremely important.

The sexually transmitted disease (STD) epidemic in the United States is intensifying, and it disproportionately impacts high-risk communities. In 2018, rates of reportable STDs, including syphilis and Neisseria gonorrhoeae and Chlamydia trachomatis infections, reached an all-time high.¹ That year, there were 1.8 million cases of chlamydia (increased 19% since 2014), 583,405 cases of gonorrhea (increased 63% since 2014), and 35,063 cases of primary and secondary syphilis (71% increase from 2014).¹

Cases of newborn syphilis have more than doubled in 4 years, with rates reaching a 20-year high.¹

This surge has not received the attention it deserves given the broad-reaching impact of these infections on women’s health and maternal-child health.² As ObGyns, we are on the front line, and we need to be engaged in evidence-based strategies and population-based health initiatives to expedite diagnoses and treatment and to reduce the ongoing spread of these infections.

Disparities exist and continue to fuel this epidemic

The STD burden is disproportionately high among reproductive-aged women, and half of all reported STDs occur in women aged 15 to 24 years. African American women have rates up to 12 times higher than white women.^3,4 Substantial geographic variability also exists, with the South, Southeast, and West having some of the highest STD rates.

These disparities are fueled by inequalities in socioeconomic status (SES), including employment, insurance, education, incarceration, stress/trauma exposure, and discrimination.^5-7 Those with lower SES often have trouble accessing and affording quality health care, including sexual health services. Access to quality health care, including STD prevention and treatment, that meets the needs of lower SES populations is key to reducing STD disparities in the United States; however, access likely will be insufficient unless the structural inequities that drive these disparities are addressed.

Clinical consequences for women, infants, and mothers

STDs are most prevalent among reproductive-aged women and can lead to pelvic inflammatory disease, infertility, ectopic pregnancy,^4,8 and increased risk of acquiring human immunodeficiency virus (HIV). STDs during pregnancy present additional consequences. Congenital syphilis is perhaps the most salient, with neonates experiencing substantial disability or death.

In addition, STDs contribute to overall peripartum and long-term adverse health outcomes.^4,9,10 Untreated chlamydia infection, for example, is associated with neonatal pneumonia, neonatal conjunctivitis, low birth weight, premature rupture of membranes, preterm labor, and postpartum endometritis.^2,11 Untreated gonorrhea is linked to disseminated gonococcal infection in the newborn, neonatal conjunctivitis, low birth weight, miscarriage, premature rupture of membranes, preterm labor, and chorioamnionitis.^2,12

As preterm birth is the leading cause of infant morbidity and mortality and disproportionately affects African American women and women in the southeastern United States,¹³ there is a critical public heath need to improve STD screening, treatment, and prevention of reinfection among high-risk pregnant women.

Quality clinical services for STDs: Areas for focus

More and more, STDs are being diagnosed in primary care settings. In January 2020, the Centers for Disease Control and Prevention (CDC) released a document, referred to as STD QCS (quality clinical services), that outlines recommendations for basic and specialty-level STD clinical services.¹⁴ ObGyns and other clinicians who provide primary care should meet the basic recommendations as a minimum.

The STD QCS outlines 8 recommendation areas: sexual history and physical examination, prevention, screening, partner services, evaluation of STD-related conditions, laboratory, treatment, and referral to a specialist for complex STD or STD-related conditions.¹⁴ These recommendations can be used by providers, managers, advocates, and others working to implement the highest-quality STD clinical services. Below are key areas that can be addressed in ObGyn practice.

Continue to: Sexual history and physical examination...

Sexual history and physical examination

A complete sexual history and risk assessment should be performed at a complete initial or annual visit and as indicated. Routinely updating the sexual history and risk assessment is important to normalize these questions within the frame of the person’s overall health, and it may be valuable in reducing stigma. This routine approach may be important particularly for younger patients and others whose risk for STDs may change frequently and dramatically.

Creating a safe space that permits privacy and assurance of confidentiality may help build trust and set the stage for disclosure. The American College of Obstetricians and Gynecologists recommends that all young people have time alone without parents for confidential counseling and discussion.¹⁵ All states allow minors to consent for STD services themselves, although 11 states limit this to those beyond a certain age.¹⁶

The CDC recommends using the 5 P’s—partners, practices, protection, past history of STDs, and prevention of pregnancy—as a guide for discussion.¹⁴ ObGyns are more likely than other providers to perform this screening routinely. While a pelvic examination should be available for STD evaluation as needed, it is not required for routine screening.

Prevention

ObGyns should employ several recommendations for STD prevention. These include providing or referring patients for vaccination against hepatitis B and human papillomavirus and providing brief STD/HIV prevention counseling along with contraceptive counseling. ObGyns should be familiar with HIV pre-exposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP) and provide risk assessment, education, and referral or link to HIV care. Providing these services would improve access to care and further remove barriers to care. ObGyns also could consider providing condoms in their offices.¹⁴

Screening

STD screening of women at risk is critical since more than 80% of infected women are asymptomatic.⁸ Because young people are disproportionately experiencing STDs, annual screening for chlamydia and gonorrhea is recommended for women younger than 25 years. For women older than 25, those at increased risk can be screened.

Risk factors for chlamydia infection include having new or multiple sex partners, sex partners with concurrent partners, or sex partners who have an STD. For gonorrhea, risk factors include living in a high-morbidity area, having a previous or coexisting STD, new or multiple sex partners, inconsistent condom use in people who are not in a mutually monogamous relationship, and exchanging sex for money or drugs. Screening for syphilis in nonpregnant women is recommended for those who have had any sexual activity with a person recently diagnosed with syphilis or those who personally display signs or symptoms of infection.¹⁷

STD screening is especially important for pregnant women, and treatment of infections may improve pregnancy outcomes. The CDC recommends screening at the first prenatal care visit for chlamydia and gonorrhea in pregnant women younger than 25 years of age and in older pregnant women at increased risk; women younger than 25 years or at continued high risk should be rescreened in their third trimester. The CDC recommends screening all women for syphilis at their first prenatal care visit and rescreening those at high risk in the third trimester and at delivery (TABLE).¹⁸

Continue to: Partner services...

Partner services

Clearly outlined partner management services is paramount for preventing STD reinfection.¹⁴ Reinfection rates for chlamydia and gonorrhea among young women are high and vary by study population.¹⁹ At a minimum, ObGyns should counsel patients with an STD that their partner(s) should be notified and encouraged to seek services.

For states in which it is legal, expedited partner therapy (EPT)—the clinician provides medication for the partner without seeing the partner—should be provided for chlamydia or gonorrhea if the partner is unlikely to access timely care. EPT is legal in most states. (To check the legal status of EPT in your state, visit https://www.cdc.gov/std/ept/legal/default.htm.) Research is needed to evaluate optimal strategies for effective implementation of EPT services in different clinical settings.

Laboratory tests

ObGyns should be able to provide a wide range of laboratory evaluations (for example, a nucleic acid amplification test [NAAT] for genital chlamydia and gonorrhea, quantitative nontreponemal serologic test for syphilis, treponemal serologic test for syphilis) that can be ordered for screening or diagnostic purposes. To improve rates of recommended screening, consider having clinic-level policies that support screening, such as standing orders, express or walk-in screening appointments, lab panels, and reflex testing.

Further, having rapid results or point-of-care testing available would help decrease lags in time to treatment. Delays in treatment are particularly important in lower-resource communities; thus, point-of-care testing may be especially valuable with immediate access to treatment on site.

Treatment

Adequate and timely treatment of STDs is critical to decrease sequelae and the likelihood of transmission to others. Treatment is evolving, particularly for gonorrhea. Over the past several years, gonorrhea has become resistant to 6 previously recommended treatment options.²⁰ Since 2015, the CDC recommends dual therapy for gonorrhea with an injection of ceftriaxone and oral azithromycin.

The first-line recommended treatments for bacterial STDs are listed in the TABLE. When possible, it is preferred to offer directly observed therapy at the time of the visit. This decreases the time to treatment and ensures that therapy is completed.

A call to action for ObGyns

Clinicians have multiple opportunities to address and reduce the surge of STDs in the United States. We play a critical role in screening, diagnosing, and treating patients, and it is thus imperative to be up-to-date on the recommended guidelines. Further, clinicians can advocate for more rapid testing modalities, with the goal of obtaining point-of-care testing results when possible and implementing strategies to improve partner treatment.

While a positive STD result may be associated with significant patient distress, it also may be an opportunity for enhancing the patient-provider relationship, coupling education with motivational approaches to help patients increase protective health behaviors.

It is critical to approach clinical care in a nonjudgmental manner to improve patients’ comfort in their relationship with the health care system. ●

The sexually transmitted disease (STD) epidemic in the United States is intensifying, and it disproportionately impacts high-risk communities. In 2018, rates of reportable STDs, including syphilis and Neisseria gonorrhoeae and Chlamydia trachomatis infections, reached an all-time high.¹ That year, there were 1.8 million cases of chlamydia (increased 19% since 2014), 583,405 cases of gonorrhea (increased 63% since 2014), and 35,063 cases of primary and secondary syphilis (71% increase from 2014).¹

Cases of newborn syphilis have more than doubled in 4 years, with rates reaching a 20-year high.¹

This surge has not received the attention it deserves given the broad-reaching impact of these infections on women’s health and maternal-child health.² As ObGyns, we are on the front line, and we need to be engaged in evidence-based strategies and population-based health initiatives to expedite diagnoses and treatment and to reduce the ongoing spread of these infections.

Disparities exist and continue to fuel this epidemic

The STD burden is disproportionately high among reproductive-aged women, and half of all reported STDs occur in women aged 15 to 24 years. African American women have rates up to 12 times higher than white women.^3,4 Substantial geographic variability also exists, with the South, Southeast, and West having some of the highest STD rates.

These disparities are fueled by inequalities in socioeconomic status (SES), including employment, insurance, education, incarceration, stress/trauma exposure, and discrimination.^5-7 Those with lower SES often have trouble accessing and affording quality health care, including sexual health services. Access to quality health care, including STD prevention and treatment, that meets the needs of lower SES populations is key to reducing STD disparities in the United States; however, access likely will be insufficient unless the structural inequities that drive these disparities are addressed.

Clinical consequences for women, infants, and mothers

STDs are most prevalent among reproductive-aged women and can lead to pelvic inflammatory disease, infertility, ectopic pregnancy,^4,8 and increased risk of acquiring human immunodeficiency virus (HIV). STDs during pregnancy present additional consequences. Congenital syphilis is perhaps the most salient, with neonates experiencing substantial disability or death.

In addition, STDs contribute to overall peripartum and long-term adverse health outcomes.^4,9,10 Untreated chlamydia infection, for example, is associated with neonatal pneumonia, neonatal conjunctivitis, low birth weight, premature rupture of membranes, preterm labor, and postpartum endometritis.^2,11 Untreated gonorrhea is linked to disseminated gonococcal infection in the newborn, neonatal conjunctivitis, low birth weight, miscarriage, premature rupture of membranes, preterm labor, and chorioamnionitis.^2,12

As preterm birth is the leading cause of infant morbidity and mortality and disproportionately affects African American women and women in the southeastern United States,¹³ there is a critical public heath need to improve STD screening, treatment, and prevention of reinfection among high-risk pregnant women.

Quality clinical services for STDs: Areas for focus

More and more, STDs are being diagnosed in primary care settings. In January 2020, the Centers for Disease Control and Prevention (CDC) released a document, referred to as STD QCS (quality clinical services), that outlines recommendations for basic and specialty-level STD clinical services.¹⁴ ObGyns and other clinicians who provide primary care should meet the basic recommendations as a minimum.

The STD QCS outlines 8 recommendation areas: sexual history and physical examination, prevention, screening, partner services, evaluation of STD-related conditions, laboratory, treatment, and referral to a specialist for complex STD or STD-related conditions.¹⁴ These recommendations can be used by providers, managers, advocates, and others working to implement the highest-quality STD clinical services. Below are key areas that can be addressed in ObGyn practice.

Continue to: Sexual history and physical examination...

Sexual history and physical examination

A complete sexual history and risk assessment should be performed at a complete initial or annual visit and as indicated. Routinely updating the sexual history and risk assessment is important to normalize these questions within the frame of the person’s overall health, and it may be valuable in reducing stigma. This routine approach may be important particularly for younger patients and others whose risk for STDs may change frequently and dramatically.

Creating a safe space that permits privacy and assurance of confidentiality may help build trust and set the stage for disclosure. The American College of Obstetricians and Gynecologists recommends that all young people have time alone without parents for confidential counseling and discussion.¹⁵ All states allow minors to consent for STD services themselves, although 11 states limit this to those beyond a certain age.¹⁶

The CDC recommends using the 5 P’s—partners, practices, protection, past history of STDs, and prevention of pregnancy—as a guide for discussion.¹⁴ ObGyns are more likely than other providers to perform this screening routinely. While a pelvic examination should be available for STD evaluation as needed, it is not required for routine screening.

Prevention

ObGyns should employ several recommendations for STD prevention. These include providing or referring patients for vaccination against hepatitis B and human papillomavirus and providing brief STD/HIV prevention counseling along with contraceptive counseling. ObGyns should be familiar with HIV pre-exposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP) and provide risk assessment, education, and referral or link to HIV care. Providing these services would improve access to care and further remove barriers to care. ObGyns also could consider providing condoms in their offices.¹⁴

Screening

STD screening of women at risk is critical since more than 80% of infected women are asymptomatic.⁸ Because young people are disproportionately experiencing STDs, annual screening for chlamydia and gonorrhea is recommended for women younger than 25 years. For women older than 25, those at increased risk can be screened.

Risk factors for chlamydia infection include having new or multiple sex partners, sex partners with concurrent partners, or sex partners who have an STD. For gonorrhea, risk factors include living in a high-morbidity area, having a previous or coexisting STD, new or multiple sex partners, inconsistent condom use in people who are not in a mutually monogamous relationship, and exchanging sex for money or drugs. Screening for syphilis in nonpregnant women is recommended for those who have had any sexual activity with a person recently diagnosed with syphilis or those who personally display signs or symptoms of infection.¹⁷

STD screening is especially important for pregnant women, and treatment of infections may improve pregnancy outcomes. The CDC recommends screening at the first prenatal care visit for chlamydia and gonorrhea in pregnant women younger than 25 years of age and in older pregnant women at increased risk; women younger than 25 years or at continued high risk should be rescreened in their third trimester. The CDC recommends screening all women for syphilis at their first prenatal care visit and rescreening those at high risk in the third trimester and at delivery (TABLE).¹⁸

Continue to: Partner services...

Partner services

Clearly outlined partner management services is paramount for preventing STD reinfection.¹⁴ Reinfection rates for chlamydia and gonorrhea among young women are high and vary by study population.¹⁹ At a minimum, ObGyns should counsel patients with an STD that their partner(s) should be notified and encouraged to seek services.

For states in which it is legal, expedited partner therapy (EPT)—the clinician provides medication for the partner without seeing the partner—should be provided for chlamydia or gonorrhea if the partner is unlikely to access timely care. EPT is legal in most states. (To check the legal status of EPT in your state, visit https://www.cdc.gov/std/ept/legal/default.htm.) Research is needed to evaluate optimal strategies for effective implementation of EPT services in different clinical settings.

Laboratory tests

ObGyns should be able to provide a wide range of laboratory evaluations (for example, a nucleic acid amplification test [NAAT] for genital chlamydia and gonorrhea, quantitative nontreponemal serologic test for syphilis, treponemal serologic test for syphilis) that can be ordered for screening or diagnostic purposes. To improve rates of recommended screening, consider having clinic-level policies that support screening, such as standing orders, express or walk-in screening appointments, lab panels, and reflex testing.

Further, having rapid results or point-of-care testing available would help decrease lags in time to treatment. Delays in treatment are particularly important in lower-resource communities; thus, point-of-care testing may be especially valuable with immediate access to treatment on site.

Treatment

Adequate and timely treatment of STDs is critical to decrease sequelae and the likelihood of transmission to others. Treatment is evolving, particularly for gonorrhea. Over the past several years, gonorrhea has become resistant to 6 previously recommended treatment options.²⁰ Since 2015, the CDC recommends dual therapy for gonorrhea with an injection of ceftriaxone and oral azithromycin.

The first-line recommended treatments for bacterial STDs are listed in the TABLE. When possible, it is preferred to offer directly observed therapy at the time of the visit. This decreases the time to treatment and ensures that therapy is completed.

A call to action for ObGyns

Clinicians have multiple opportunities to address and reduce the surge of STDs in the United States. We play a critical role in screening, diagnosing, and treating patients, and it is thus imperative to be up-to-date on the recommended guidelines. Further, clinicians can advocate for more rapid testing modalities, with the goal of obtaining point-of-care testing results when possible and implementing strategies to improve partner treatment.

While a positive STD result may be associated with significant patient distress, it also may be an opportunity for enhancing the patient-provider relationship, coupling education with motivational approaches to help patients increase protective health behaviors.

It is critical to approach clinical care in a nonjudgmental manner to improve patients’ comfort in their relationship with the health care system. ●

The sexually transmitted disease (STD) epidemic in the United States is intensifying, and it disproportionately impacts high-risk communities. In 2018, rates of reportable STDs, including syphilis and Neisseria gonorrhoeae and Chlamydia trachomatis infections, reached an all-time high.¹ That year, there were 1.8 million cases of chlamydia (increased 19% since 2014), 583,405 cases of gonorrhea (increased 63% since 2014), and 35,063 cases of primary and secondary syphilis (71% increase from 2014).¹

Cases of newborn syphilis have more than doubled in 4 years, with rates reaching a 20-year high.¹

This surge has not received the attention it deserves given the broad-reaching impact of these infections on women’s health and maternal-child health.² As ObGyns, we are on the front line, and we need to be engaged in evidence-based strategies and population-based health initiatives to expedite diagnoses and treatment and to reduce the ongoing spread of these infections.

Disparities exist and continue to fuel this epidemic

The STD burden is disproportionately high among reproductive-aged women, and half of all reported STDs occur in women aged 15 to 24 years. African American women have rates up to 12 times higher than white women.^3,4 Substantial geographic variability also exists, with the South, Southeast, and West having some of the highest STD rates.

These disparities are fueled by inequalities in socioeconomic status (SES), including employment, insurance, education, incarceration, stress/trauma exposure, and discrimination.^5-7 Those with lower SES often have trouble accessing and affording quality health care, including sexual health services. Access to quality health care, including STD prevention and treatment, that meets the needs of lower SES populations is key to reducing STD disparities in the United States; however, access likely will be insufficient unless the structural inequities that drive these disparities are addressed.

Clinical consequences for women, infants, and mothers

STDs are most prevalent among reproductive-aged women and can lead to pelvic inflammatory disease, infertility, ectopic pregnancy,^4,8 and increased risk of acquiring human immunodeficiency virus (HIV). STDs during pregnancy present additional consequences. Congenital syphilis is perhaps the most salient, with neonates experiencing substantial disability or death.

In addition, STDs contribute to overall peripartum and long-term adverse health outcomes.^4,9,10 Untreated chlamydia infection, for example, is associated with neonatal pneumonia, neonatal conjunctivitis, low birth weight, premature rupture of membranes, preterm labor, and postpartum endometritis.^2,11 Untreated gonorrhea is linked to disseminated gonococcal infection in the newborn, neonatal conjunctivitis, low birth weight, miscarriage, premature rupture of membranes, preterm labor, and chorioamnionitis.^2,12

As preterm birth is the leading cause of infant morbidity and mortality and disproportionately affects African American women and women in the southeastern United States,¹³ there is a critical public heath need to improve STD screening, treatment, and prevention of reinfection among high-risk pregnant women.

Quality clinical services for STDs: Areas for focus

More and more, STDs are being diagnosed in primary care settings. In January 2020, the Centers for Disease Control and Prevention (CDC) released a document, referred to as STD QCS (quality clinical services), that outlines recommendations for basic and specialty-level STD clinical services.¹⁴ ObGyns and other clinicians who provide primary care should meet the basic recommendations as a minimum.

The STD QCS outlines 8 recommendation areas: sexual history and physical examination, prevention, screening, partner services, evaluation of STD-related conditions, laboratory, treatment, and referral to a specialist for complex STD or STD-related conditions.¹⁴ These recommendations can be used by providers, managers, advocates, and others working to implement the highest-quality STD clinical services. Below are key areas that can be addressed in ObGyn practice.

Continue to: Sexual history and physical examination...

Sexual history and physical examination

A complete sexual history and risk assessment should be performed at a complete initial or annual visit and as indicated. Routinely updating the sexual history and risk assessment is important to normalize these questions within the frame of the person’s overall health, and it may be valuable in reducing stigma. This routine approach may be important particularly for younger patients and others whose risk for STDs may change frequently and dramatically.

Creating a safe space that permits privacy and assurance of confidentiality may help build trust and set the stage for disclosure. The American College of Obstetricians and Gynecologists recommends that all young people have time alone without parents for confidential counseling and discussion.¹⁵ All states allow minors to consent for STD services themselves, although 11 states limit this to those beyond a certain age.¹⁶

The CDC recommends using the 5 P’s—partners, practices, protection, past history of STDs, and prevention of pregnancy—as a guide for discussion.¹⁴ ObGyns are more likely than other providers to perform this screening routinely. While a pelvic examination should be available for STD evaluation as needed, it is not required for routine screening.

Prevention

ObGyns should employ several recommendations for STD prevention. These include providing or referring patients for vaccination against hepatitis B and human papillomavirus and providing brief STD/HIV prevention counseling along with contraceptive counseling. ObGyns should be familiar with HIV pre-exposure prophylaxis (PrEP) and nonoccupational postexposure prophylaxis (nPEP) and provide risk assessment, education, and referral or link to HIV care. Providing these services would improve access to care and further remove barriers to care. ObGyns also could consider providing condoms in their offices.¹⁴

Screening

STD screening of women at risk is critical since more than 80% of infected women are asymptomatic.⁸ Because young people are disproportionately experiencing STDs, annual screening for chlamydia and gonorrhea is recommended for women younger than 25 years. For women older than 25, those at increased risk can be screened.

Risk factors for chlamydia infection include having new or multiple sex partners, sex partners with concurrent partners, or sex partners who have an STD. For gonorrhea, risk factors include living in a high-morbidity area, having a previous or coexisting STD, new or multiple sex partners, inconsistent condom use in people who are not in a mutually monogamous relationship, and exchanging sex for money or drugs. Screening for syphilis in nonpregnant women is recommended for those who have had any sexual activity with a person recently diagnosed with syphilis or those who personally display signs or symptoms of infection.¹⁷

STD screening is especially important for pregnant women, and treatment of infections may improve pregnancy outcomes. The CDC recommends screening at the first prenatal care visit for chlamydia and gonorrhea in pregnant women younger than 25 years of age and in older pregnant women at increased risk; women younger than 25 years or at continued high risk should be rescreened in their third trimester. The CDC recommends screening all women for syphilis at their first prenatal care visit and rescreening those at high risk in the third trimester and at delivery (TABLE).¹⁸

Continue to: Partner services...

Partner services

Clearly outlined partner management services is paramount for preventing STD reinfection.¹⁴ Reinfection rates for chlamydia and gonorrhea among young women are high and vary by study population.¹⁹ At a minimum, ObGyns should counsel patients with an STD that their partner(s) should be notified and encouraged to seek services.

For states in which it is legal, expedited partner therapy (EPT)—the clinician provides medication for the partner without seeing the partner—should be provided for chlamydia or gonorrhea if the partner is unlikely to access timely care. EPT is legal in most states. (To check the legal status of EPT in your state, visit https://www.cdc.gov/std/ept/legal/default.htm.) Research is needed to evaluate optimal strategies for effective implementation of EPT services in different clinical settings.

Laboratory tests

ObGyns should be able to provide a wide range of laboratory evaluations (for example, a nucleic acid amplification test [NAAT] for genital chlamydia and gonorrhea, quantitative nontreponemal serologic test for syphilis, treponemal serologic test for syphilis) that can be ordered for screening or diagnostic purposes. To improve rates of recommended screening, consider having clinic-level policies that support screening, such as standing orders, express or walk-in screening appointments, lab panels, and reflex testing.

Further, having rapid results or point-of-care testing available would help decrease lags in time to treatment. Delays in treatment are particularly important in lower-resource communities; thus, point-of-care testing may be especially valuable with immediate access to treatment on site.

Treatment

Adequate and timely treatment of STDs is critical to decrease sequelae and the likelihood of transmission to others. Treatment is evolving, particularly for gonorrhea. Over the past several years, gonorrhea has become resistant to 6 previously recommended treatment options.²⁰ Since 2015, the CDC recommends dual therapy for gonorrhea with an injection of ceftriaxone and oral azithromycin.

The first-line recommended treatments for bacterial STDs are listed in the TABLE. When possible, it is preferred to offer directly observed therapy at the time of the visit. This decreases the time to treatment and ensures that therapy is completed.

A call to action for ObGyns

Clinicians have multiple opportunities to address and reduce the surge of STDs in the United States. We play a critical role in screening, diagnosing, and treating patients, and it is thus imperative to be up-to-date on the recommended guidelines. Further, clinicians can advocate for more rapid testing modalities, with the goal of obtaining point-of-care testing results when possible and implementing strategies to improve partner treatment.

While a positive STD result may be associated with significant patient distress, it also may be an opportunity for enhancing the patient-provider relationship, coupling education with motivational approaches to help patients increase protective health behaviors.

It is critical to approach clinical care in a nonjudgmental manner to improve patients’ comfort in their relationship with the health care system. ●

The Food and Drug Administration has updated the labels for peginterferon beta-1a (Plegridy) and interferon beta-1a (Avonex) to include more information about usage of these medications during pregnancy and breastfeeding in women with multiple sclerosis (MS).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.

As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.

The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.

“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.

[email protected]

The Food and Drug Administration has updated the labels for peginterferon beta-1a (Plegridy) and interferon beta-1a (Avonex) to include more information about usage of these medications during pregnancy and breastfeeding in women with multiple sclerosis (MS).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.

As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.

The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.

“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.

[email protected]

The Food and Drug Administration has updated the labels for peginterferon beta-1a (Plegridy) and interferon beta-1a (Avonex) to include more information about usage of these medications during pregnancy and breastfeeding in women with multiple sclerosis (MS).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA based the decision on data from more than 1,000 real-world pregnancies, including pregnancies from a large epidemiologic study and published studies over several decades, which found no connection between use of interferon-beta products during early pregnancy and an increased risk of major birth defects, according to the FDA.

As a result, the labels for both medications will no longer have the pregnancy category C designation; however, patients should continue to notify their health care provider if they are pregnant or plan to become pregnant.

The FDA decision to remove the warning follows a similar decision by the European Medicines Agency last year.

“Many women with MS are diagnosed during their childbearing years. With this important update for Plegridy and Avonex, healthcare providers have more data to inform appropriate treatment paths for patients who may be pregnant or planning for pregnancy,” said Bernd Kieseier, MD, MHBA, executive director and head of global MS at Worldwide Medical, Biogen, in a press release.

[email protected]