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Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Racial and ethnic disparities in maternal and infant outcomes persist in the United States, with Black women being 3-4 times more likely to die of pregnancy-related causes, compared with Latina and non-Latina white women, Elizabeth Howell, MD, said in a presentation at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Location matters, too, and ethnic disparities appear to transcend class, said Dr. Howell of Penn Medicine, Philadelphia. In New York City, for example, Black women are 8-12 times more likely to die than white women regardless of educational attainment.

Dr. Howell cited the definitions of health equity and health disparities as defined by Paula Braveman, MD, in 2014 in the journal Public Health Reports, as follows: “Health equity means social justice in health (i.e., no one is denied the possibility to be healthy for belonging to a group that has historically been economically/socially disadvantaged. Health disparities are the metric we use to measure progress toward achieving health equity.”

Structural racism and discrimination contribute to disparities in maternal and infant morbidity and mortality in several ways, she said. Patient factors include sociodemographics, age, education, poverty, insurance, marital status, language, and literacy. In addition, a patient’s knowledge, beliefs, and health behaviors, as well as stress and self-efficacy are involved. Community factors such as crime, poverty, and community support play a role.

“These factors contribute to the health status of a woman when she becomes pregnant,” Dr. Howell said. “These factors contribute as the woman goes through the health system.”

Then provider factors that impact maternal and infant morbidity and mortality include knowledge, experience, implicit bias, cultural humility, and communication; these factors affect the quality and delivery of neonatal care, and can impact outcomes, Dr. Howell said.

“It is really important to note that many of these pregnancy-related deaths are thought to be preventable,” she said. “They are often caused by delays in diagnosis, problems with communication, and other system failures. Site care has received a great deal of attention” in recent years, the ob.gyn. noted.
 

How hospital quality contributes to health disparities

Dr. Howell shared data from a pair of National Institutes of Health–funded parallel group studies she conducted at New York City hospitals to investigate the contribution of hospital quality to health disparities in severe maternal morbidity and very preterm birth (prior to 32 weeks).

The researchers used vital statistics linked with discharge abstracts for all New York City deliveries between 2011-2013 and 2010-2014. They conducted a logistic regression analysis and ranked hospitals based on metrics of severe maternal morbidity and very preterm birth, and assessed differences by race in each delivery location.

Overall, Black women were almost three times as likely and Latina women were almost twice as likely as White women to experience some type of severe maternal morbidity, with rates of 4.2%, 2.7%, and 1.5%, respectively.

The researchers also ranked hospitals, and found a wide variation; women delivering in the lowest-ranked hospitals had six times the rate of severe maternal morbidity. They also conducted a simulation/thought exercise and determined that the hospital of delivery accounted for approximately 48% of the disparity in severe maternal morbidity between Black and White women.

Results were similar in the parallel study of very preterm birth rates in New York City hospitals, which were 32%, 28%, and 23% for Black, Latina, and White women, respectively.

The researchers also conducted interviews with personnel including chief medical officers, neonatal ICU directors, nurses, and respiratory therapists. The final phase of the research, which is ongoing, is the dissemination of the information, said Dr. Howell.

Overall, the high-performing hospitals were more likely to focus on standards and standardized care, stronger nurse/physician communication, greater awareness of the potential impact of racism on care, and greater sharing of performance data.

Women who participated in focus groups reported a range of experiences, but women of color were likely to report poor communication, feeling traumatized, and not being heard.
 

Study implications

Dr. Howell discussed the implications of her study in a question and answer session. “It is incredibly important for us to think about all the levers that we have to address disparities.”

“It is a complex web of factors, but quality of care is one of those mechanisms, and it is something we can do something about,” she noted.

In response to a question about whether women should know the rates of adverse outcomes at various hospitals, she said, “I think we have a responsibility to come up with quality of care measures that are informative to the women we care for.”

Much of obstetric quality issues focus on overuse of resources, “but that doesn’t help us reduce disparities,” she said.

Dr. Howell had no financial conflicts to disclose.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

Women who use substances during pregnancy need support and education, not judgment, to promote the best outcomes, according to a panel of experts speaking at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. The panelists highlighted several key issues for addressing alcohol, opioids, and cannabis use by pregnant women.

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

Many women believe that a limited amount of alcohol is safe during pregnancy, in part because of mixed messages in the media suggesting that light drinking is okay, according to Erin Tracy Bradley, MD, MPH, of Massachusetts General Hospital, Boston.

“We need to do a better job teaching our patients about the potential dangers of alcohol,” Dr. Bradley said in her presentation.

In fact, data suggest that women more at risk for an alcohol-exposed pregnancy are older and better educated. Dr. Bradley described the pattern of malformation for fetal alcohol syndrome (FAS) that includes small eyes, a thin upper lip, and smooth skin between the upper lip and nose.

“The only cause we know of [for FAS] is alcohol exposure intrauterine for the fetus,” so it is preventable with counseling and care, and thought to be the leading preventable cause of birth defects during pregnancies, she said.

The bottom line is that there is no safe amount of alcohol,” said Dr. Bradley. However, providers are inconsistent in discussing alcohol with their pregnant patients. In addition, universal screening is important because it is difficult to predict which women will be drinking during pregnancy.

Screening allows providers to quickly assess the severity of substance use, offer a brief intervention to raise patient awareness, and refer if necessary. “There should be ‘absolutely no judgment, no shame, no stigma,’ ” Dr. Bradley emphasized. “We are the patient’s partners, and we are trying to help them have a healthy pregnancy. “

Opioid use in pregnancy spiked in recent decades

“Women have always been overrepresented when opioids are involved,” said Tricia E. Wright, MD, of the University of California, San Francisco.

Long-term studies have shown that, overall, women are more likely to be given opioids and given higher doses, compared with men, often for conditions in which opioids are not effective, she noted.

Women use substances differently than men; “they use them to cope with everyday life,” and a history of interpersonal violence and sexual assault are coming among women with opioid use disorders, said Dr. Wright.

The majority of women with opioid use disorders are of childbearing age, which has led to an increase in neonatal abstinence syndrome (NAS) said Dr. Wright.

She cited 2014 data from the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report showing an increase in NAS from 1.2 per 1,000 hospital births in 2000 to 5.8 per 1,000 hospital births in 2012. This increase has led to “misguided” efforts to prevent NAS through opioid detoxification, Dr. Wright said. She and colleagues conducted a systematic review in 2018 and found that, in fact, the evidence does not support detoxification as a recommended treatment intervention during pregnancy.

Opioid agonist therapy has multiple benefits for both the mother and fetus, Dr. Wright said. Maternal benefits include reduction in overdose-related deaths; decrease in the risk of HIV, hepatitis B, and hepatitis C; and increased engagement in prenatal care and recovery treatment. Fetal benefits include reduced fetal stress with the reduced fluctuations in maternal opioid levels, as well as decreases in intrauterine fetal death, intrauterine growth restriction, and preterm delivery.

“We know that relapse kills” because patients lose their tolerance, Dr. Wright said. “What we have seen is that overdose deaths are a leading cause of death in the postpartum period.”

When it comes to treatment, both methadone and buprenorphine are safe and effective options in pregnancy, she said. Treatment decisions should be made based on available options, patient preference, and a patient’s previous treatment experiences, as well as disease severity, social support, and the intensity of treatment needed.

“Whatever medicine you choose, it takes a village to coordinate the care,” Dr. Wright said. Maternal dose has no effect on neonatal withdrawal, so women should be encouraged to report any concerns. Either medication is compatible with breastfeeding. In fact, breastfeeding has many benefits in preventing neonatal withdrawal syndrome. Smoking cessation should be encouraged because it improves neonatal withdrawal.

Minimizing stigma is paramount, said Dr. Wright. “Substance use disorders are among the most stigmatized medical conditions, and pregnant women with substance use disorders are even more stigmatized.”

Clinicians can support patients by focusing on appropriate language, patients aren’t “addicts,” they are people with an opioid use disorder, she said.

Compassionate care for cannabis users

Cannabis use has a long history of association with women’s health, said Mishka Terplan, MD, MPH, of Friends Research Institute, Baltimore. Although cannabis use overall has increased steadily in recent years, data indicate that people who are pregnant are less likely to use cannabis than those who aren’t. The exception is that individuals who report using cannabis for medical purposes only remain consistent cannabis users during pregnancy.

“The concern is cannabis and birth outcomes, as well as developmental outcomes,” Dr. Terplan said. Multiple studies on this topic support several systematic reviews, and “depending on which decade you read, the results differ slightly.”

Reviews from the 1990s showed little to no effect on birth weight, but more recent studies, such as a meta-analysis published in BMJ Open in 2015, showed increased risk of neonatal outcomes such as low birth weight, anemia, and odds of admission to the neonatal ICU.

“The difference in these two eras is thought to be caused by the change in the definition of what cannabis is, and the potency has increased, and possibly therefore, as a consequence, we see outcomes we hadn’t seen before,” Dr. Terplan explained.

There is a concern with increased use and increased legalization that, there could be adverse effects on neonatal health, but recent studies in Colorado do not show a significant difference in neonatal outcomes before and after legalization, he said.

Data from pregnant women suggest that with regard to cannabis, they are concerned about their health, but they tend to seek information about cannabis use in pregnancy from family, friends, and the Internet rather than their health providers, said Dr. Terplan.

However, studies also show that providers tend to fall short and do a poor job of talking to pregnant patients about cannabis. When providers do discuss cannabis, they tend to focus on the legal aspects. “We are failing our patients when it comes to cannabis,” Dr. Terplan said. “We don’t provide the information and support they need and desire.” Instead, many providers “deploy urine drug testing, which we misinterpret.”

Dr. Terplan explained that point-of-care cannabis testing that shows “THC” is not measuring tetrahydrocannabinol, the psychoactive compound; rather it captures the nonpsychoactive metabolite of THC, one that sticks around for a long time in the biological compartment.

Dr. Terplan urged clinicians not to use urine tests as a default indicator of cannabis use, but instead, “we need to sit, listen, and work with our patients from a place of empathy.”
 

Questions answered

During a question-and-answer session following the panel, Dr. Bradley was asked about preconception counseling related to alcohol consumption.

“Preconception time is a perfect time to do screening, or offer contraception if a patient is a place where she doesn’t want to become pregnant or if she wants to take advantage of any therapeutic options to get well prior to pregnancy,” she said.

Dr. Wright responded to a question about the impact of punitive actions such as drug testing and incarceration. “These things decrease the chance that patients will get adequate prenatal care,” she said. “We need to advocate for our patients and advocate for changing drug laws.”

Dr. Terplan responded to a question about the impact of substance use on parenting. Parents use nicotine, alcohol, and also cannabis, he said. Data showing an association between substance use and cases of child abuse and neglect, “are of poor quality and do not support this association.”

Overall, “we need to have consistent messaging that we are not there to judge patients,” Dr. Bradley added. “The last thing we want is for patients not to be honest with us.”

Dr. Wright disclosed consulting fees from McKesson and royalties as the coauthor of a book, “Opioid-Use Disorders in Pregnancy.” Dr. Bradley had no financial conflicts to disclose. Dr. Terplan had no financial conflicts to disclose.

Labor induction at 39 weeks instead of 41 weeks may have a positive impact on neonatal outcomes, Aaron B. Caughey, MD, PhD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

For much of the 20th century, term gestation has been defined as 37 weeks and beyond, said Dr. Caughey, of Oregon Health & Science University, Portland. He noted several studies showing a U-shaped distribution in neonatal outcomes during the period from 37 weeks to 41 weeks for some outcomes, including Apgar scores. However, respiratory outcomes in a study from 2008 showed an increase, with meconium stained amniotic fluid increasing from 2.27% at 37 weeks to 10.33% at 41 weeks, and meconium aspiration increasing from 0.07% at 37 weeks to 0.27% at 41 weeks.

Late-term induction may carry more risk

The study “that really got everyone’s attention” in terms of neonatal outcomes was published in 2009 in the New England Journal of Medicine. The cohort study included 24,077 elective cesarean deliveries between 37 and 42 weeks and reviewed a range of neonatal outcomes based on gestational age.

The rate of any adverse outcome decreased from 37 weeks to 39 weeks, “but then started going back up again,” Dr. Caughey said. He reviewed data from another study that factored in stillbirth and the risk of expectant management based on gestational age. A composite risk of perinatal death with expectant management was 15.4 deaths per 10,000 cases at 37 weeks and 39 weeks, but increased to 19.9 at 42 weeks.

“The morbidity appears to have a U-shaped distribution and the mortality seems to favor delivery at 39 weeks,” he said.

When it comes to induction of labor, medically indicated vs. nonmedically indicated does matter, Dr. Caughey said. Factors not considered a medical indication include impending macrosomia, increased risk for developing preeclampsia or intrauterine growth retardation, and a favorable cervix, he noted.

“For indicated induction of labor, the risks and benefits of induction of labor vs. expectant management have been considered and weighed in by the field of experts that care for pregnant women,” he said. With nonmedically indicated induction, experts “either decided that risks and benefits don’t favor induction of labor, or we haven’t come down hard on what the protocol might be.

“It is important to consider the risks and benefits,” said Dr. Caughey. The factors you want to include are neonatal outcomes, maternal preferences, and doctor preferences. However, “we want to be thoughtful about this intervention,” because of the association of higher costs and increased risk of cesarean with induction of labor.

As for timing of induction of labor, certain conditions favoring early-term induction include preeclampsia and gestational hypertension, chronic hypertension, diabetes, intrauterine growth restriction, nonreassuring fetal testing, cholestasis, placenta previa or accreta, and twins.
 

Data support value of 39 weeks

As for late-term induction of labor, “at 41 weeks it is pretty clear that neonatal outcomes would be improved by delivery,” he said. Historically, clinicians have raised concerns about the increased risk of cesarean delivery following induction of labor, but this risk has not been borne out in recent studies. Dr. Caughey said. However, in the findings from the ARRIVE trial, a large study of 6,106 women who were randomized to induction or labor or expectant management at 39 weeks, “they found a reduction in their risk of cesarean delivery compared to expectant management (18.6% vs. 22.2%). Rates of preeclampsia also were lower among induced women, while rate of chorioamnionitis, postpartum hemorrhage, and intensive care were similar between the groups. The researchers did not find significant differences in perinatal outcomes.

Dr. Caughey and colleagues conducted a systematic review of cesarean risk and induction of labor, and found a risk ratio of 0.83, similar to the ARRIVE trial. “The data suggest a consistently reduced risk for cesarean delivery with the induction of labor.”

However, “I would caution us to be thoughtful about research protocols vs. actual practice,” he said. “You must think about the environment.” The latent phase of labor can continue for a long time after induction, and patience is called for, he emphasized.

Dr. Caughey said that despite the ARRIVE trial and other studies, 39 weeks should not necessarily be the new standard for induction of labor. “The proportion of women impacted is dramatically different, if you would be inducing every woman at 39 weeks, that would be 60% to 70%,” which could have a great impact on resources.

Based on current research, early-term induction of labor at 37 weeks “is a bad idea without indication,” said Dr. Caughey. Induction at 41 weeks (sometimes considered post term) is the current ACOG recommendation and is associated with improved outcomes.

Induction of labor at full term (39-40 weeks) depends in part on the environment, and is not a violation of standard of care, he said. “Evidence is evolving, and individual hospitals are trying to figure this out.”

Cesarean data are convincing, at least in some settings, he said. However, “we need more global trials and different medical settings” to determine the optimal time for induction of labor.
 

Consider maternal preferences and characteristics

During a question-and-answer session, Dr. Caughey was asked whether all women should be offered induction of labor at 39 weeks.

“I think it is OK if your entire health system has agreed to offering, to have that shared medical decision making, but you need to have careful conversation to make sure you have the resources,” he noted. Also, he said he believed clinicians should respond to women as they request labor induction at 39 weeks.

In response to a question about induction of labor in obese women, he noted that women with a body mass index greater than 35 kg/m² are not equally successful with induction of labor. “We know they have a higher risk of cesarean delivery,” however, “it has been demonstrated that they have the same potential benefits of reduced risk of cesarean.”

As for factoring in the Bishop score to determine a favorable or unfavorable cervix, Dr. Caughey noted that women with a favorable cervix are more likely to go into labor on their own, while those with an unfavorable cervix may benefit from cervical ripening.

Dr. Caughey had no financial conflicts relevant to this talk, but disclosed serving as a medical adviser to Celmatix and Mindchild, as well as an endowment to his academic department from Bob’s Red Mill, an Oregon-based whole grain foods manufacturer.

Labor induction at 39 weeks instead of 41 weeks may have a positive impact on neonatal outcomes, Aaron B. Caughey, MD, PhD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

For much of the 20th century, term gestation has been defined as 37 weeks and beyond, said Dr. Caughey, of Oregon Health & Science University, Portland. He noted several studies showing a U-shaped distribution in neonatal outcomes during the period from 37 weeks to 41 weeks for some outcomes, including Apgar scores. However, respiratory outcomes in a study from 2008 showed an increase, with meconium stained amniotic fluid increasing from 2.27% at 37 weeks to 10.33% at 41 weeks, and meconium aspiration increasing from 0.07% at 37 weeks to 0.27% at 41 weeks.

Late-term induction may carry more risk

The study “that really got everyone’s attention” in terms of neonatal outcomes was published in 2009 in the New England Journal of Medicine. The cohort study included 24,077 elective cesarean deliveries between 37 and 42 weeks and reviewed a range of neonatal outcomes based on gestational age.

The rate of any adverse outcome decreased from 37 weeks to 39 weeks, “but then started going back up again,” Dr. Caughey said. He reviewed data from another study that factored in stillbirth and the risk of expectant management based on gestational age. A composite risk of perinatal death with expectant management was 15.4 deaths per 10,000 cases at 37 weeks and 39 weeks, but increased to 19.9 at 42 weeks.

“The morbidity appears to have a U-shaped distribution and the mortality seems to favor delivery at 39 weeks,” he said.

When it comes to induction of labor, medically indicated vs. nonmedically indicated does matter, Dr. Caughey said. Factors not considered a medical indication include impending macrosomia, increased risk for developing preeclampsia or intrauterine growth retardation, and a favorable cervix, he noted.

“For indicated induction of labor, the risks and benefits of induction of labor vs. expectant management have been considered and weighed in by the field of experts that care for pregnant women,” he said. With nonmedically indicated induction, experts “either decided that risks and benefits don’t favor induction of labor, or we haven’t come down hard on what the protocol might be.

“It is important to consider the risks and benefits,” said Dr. Caughey. The factors you want to include are neonatal outcomes, maternal preferences, and doctor preferences. However, “we want to be thoughtful about this intervention,” because of the association of higher costs and increased risk of cesarean with induction of labor.

As for timing of induction of labor, certain conditions favoring early-term induction include preeclampsia and gestational hypertension, chronic hypertension, diabetes, intrauterine growth restriction, nonreassuring fetal testing, cholestasis, placenta previa or accreta, and twins.
 

Data support value of 39 weeks

As for late-term induction of labor, “at 41 weeks it is pretty clear that neonatal outcomes would be improved by delivery,” he said. Historically, clinicians have raised concerns about the increased risk of cesarean delivery following induction of labor, but this risk has not been borne out in recent studies. Dr. Caughey said. However, in the findings from the ARRIVE trial, a large study of 6,106 women who were randomized to induction or labor or expectant management at 39 weeks, “they found a reduction in their risk of cesarean delivery compared to expectant management (18.6% vs. 22.2%). Rates of preeclampsia also were lower among induced women, while rate of chorioamnionitis, postpartum hemorrhage, and intensive care were similar between the groups. The researchers did not find significant differences in perinatal outcomes.

Dr. Caughey and colleagues conducted a systematic review of cesarean risk and induction of labor, and found a risk ratio of 0.83, similar to the ARRIVE trial. “The data suggest a consistently reduced risk for cesarean delivery with the induction of labor.”

However, “I would caution us to be thoughtful about research protocols vs. actual practice,” he said. “You must think about the environment.” The latent phase of labor can continue for a long time after induction, and patience is called for, he emphasized.

Dr. Caughey said that despite the ARRIVE trial and other studies, 39 weeks should not necessarily be the new standard for induction of labor. “The proportion of women impacted is dramatically different, if you would be inducing every woman at 39 weeks, that would be 60% to 70%,” which could have a great impact on resources.

Based on current research, early-term induction of labor at 37 weeks “is a bad idea without indication,” said Dr. Caughey. Induction at 41 weeks (sometimes considered post term) is the current ACOG recommendation and is associated with improved outcomes.

Induction of labor at full term (39-40 weeks) depends in part on the environment, and is not a violation of standard of care, he said. “Evidence is evolving, and individual hospitals are trying to figure this out.”

Cesarean data are convincing, at least in some settings, he said. However, “we need more global trials and different medical settings” to determine the optimal time for induction of labor.
 

Consider maternal preferences and characteristics

During a question-and-answer session, Dr. Caughey was asked whether all women should be offered induction of labor at 39 weeks.

“I think it is OK if your entire health system has agreed to offering, to have that shared medical decision making, but you need to have careful conversation to make sure you have the resources,” he noted. Also, he said he believed clinicians should respond to women as they request labor induction at 39 weeks.

In response to a question about induction of labor in obese women, he noted that women with a body mass index greater than 35 kg/m² are not equally successful with induction of labor. “We know they have a higher risk of cesarean delivery,” however, “it has been demonstrated that they have the same potential benefits of reduced risk of cesarean.”

As for factoring in the Bishop score to determine a favorable or unfavorable cervix, Dr. Caughey noted that women with a favorable cervix are more likely to go into labor on their own, while those with an unfavorable cervix may benefit from cervical ripening.

Dr. Caughey had no financial conflicts relevant to this talk, but disclosed serving as a medical adviser to Celmatix and Mindchild, as well as an endowment to his academic department from Bob’s Red Mill, an Oregon-based whole grain foods manufacturer.

Labor induction at 39 weeks instead of 41 weeks may have a positive impact on neonatal outcomes, Aaron B. Caughey, MD, PhD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

For much of the 20th century, term gestation has been defined as 37 weeks and beyond, said Dr. Caughey, of Oregon Health & Science University, Portland. He noted several studies showing a U-shaped distribution in neonatal outcomes during the period from 37 weeks to 41 weeks for some outcomes, including Apgar scores. However, respiratory outcomes in a study from 2008 showed an increase, with meconium stained amniotic fluid increasing from 2.27% at 37 weeks to 10.33% at 41 weeks, and meconium aspiration increasing from 0.07% at 37 weeks to 0.27% at 41 weeks.

Late-term induction may carry more risk

The study “that really got everyone’s attention” in terms of neonatal outcomes was published in 2009 in the New England Journal of Medicine. The cohort study included 24,077 elective cesarean deliveries between 37 and 42 weeks and reviewed a range of neonatal outcomes based on gestational age.

The rate of any adverse outcome decreased from 37 weeks to 39 weeks, “but then started going back up again,” Dr. Caughey said. He reviewed data from another study that factored in stillbirth and the risk of expectant management based on gestational age. A composite risk of perinatal death with expectant management was 15.4 deaths per 10,000 cases at 37 weeks and 39 weeks, but increased to 19.9 at 42 weeks.

“The morbidity appears to have a U-shaped distribution and the mortality seems to favor delivery at 39 weeks,” he said.

When it comes to induction of labor, medically indicated vs. nonmedically indicated does matter, Dr. Caughey said. Factors not considered a medical indication include impending macrosomia, increased risk for developing preeclampsia or intrauterine growth retardation, and a favorable cervix, he noted.

“For indicated induction of labor, the risks and benefits of induction of labor vs. expectant management have been considered and weighed in by the field of experts that care for pregnant women,” he said. With nonmedically indicated induction, experts “either decided that risks and benefits don’t favor induction of labor, or we haven’t come down hard on what the protocol might be.

“It is important to consider the risks and benefits,” said Dr. Caughey. The factors you want to include are neonatal outcomes, maternal preferences, and doctor preferences. However, “we want to be thoughtful about this intervention,” because of the association of higher costs and increased risk of cesarean with induction of labor.

As for timing of induction of labor, certain conditions favoring early-term induction include preeclampsia and gestational hypertension, chronic hypertension, diabetes, intrauterine growth restriction, nonreassuring fetal testing, cholestasis, placenta previa or accreta, and twins.
 

Data support value of 39 weeks

As for late-term induction of labor, “at 41 weeks it is pretty clear that neonatal outcomes would be improved by delivery,” he said. Historically, clinicians have raised concerns about the increased risk of cesarean delivery following induction of labor, but this risk has not been borne out in recent studies. Dr. Caughey said. However, in the findings from the ARRIVE trial, a large study of 6,106 women who were randomized to induction or labor or expectant management at 39 weeks, “they found a reduction in their risk of cesarean delivery compared to expectant management (18.6% vs. 22.2%). Rates of preeclampsia also were lower among induced women, while rate of chorioamnionitis, postpartum hemorrhage, and intensive care were similar between the groups. The researchers did not find significant differences in perinatal outcomes.

Dr. Caughey and colleagues conducted a systematic review of cesarean risk and induction of labor, and found a risk ratio of 0.83, similar to the ARRIVE trial. “The data suggest a consistently reduced risk for cesarean delivery with the induction of labor.”

However, “I would caution us to be thoughtful about research protocols vs. actual practice,” he said. “You must think about the environment.” The latent phase of labor can continue for a long time after induction, and patience is called for, he emphasized.

Dr. Caughey said that despite the ARRIVE trial and other studies, 39 weeks should not necessarily be the new standard for induction of labor. “The proportion of women impacted is dramatically different, if you would be inducing every woman at 39 weeks, that would be 60% to 70%,” which could have a great impact on resources.

Based on current research, early-term induction of labor at 37 weeks “is a bad idea without indication,” said Dr. Caughey. Induction at 41 weeks (sometimes considered post term) is the current ACOG recommendation and is associated with improved outcomes.

Induction of labor at full term (39-40 weeks) depends in part on the environment, and is not a violation of standard of care, he said. “Evidence is evolving, and individual hospitals are trying to figure this out.”

Cesarean data are convincing, at least in some settings, he said. However, “we need more global trials and different medical settings” to determine the optimal time for induction of labor.
 

Consider maternal preferences and characteristics

During a question-and-answer session, Dr. Caughey was asked whether all women should be offered induction of labor at 39 weeks.

“I think it is OK if your entire health system has agreed to offering, to have that shared medical decision making, but you need to have careful conversation to make sure you have the resources,” he noted. Also, he said he believed clinicians should respond to women as they request labor induction at 39 weeks.

In response to a question about induction of labor in obese women, he noted that women with a body mass index greater than 35 kg/m² are not equally successful with induction of labor. “We know they have a higher risk of cesarean delivery,” however, “it has been demonstrated that they have the same potential benefits of reduced risk of cesarean.”

As for factoring in the Bishop score to determine a favorable or unfavorable cervix, Dr. Caughey noted that women with a favorable cervix are more likely to go into labor on their own, while those with an unfavorable cervix may benefit from cervical ripening.

Dr. Caughey had no financial conflicts relevant to this talk, but disclosed serving as a medical adviser to Celmatix and Mindchild, as well as an endowment to his academic department from Bob’s Red Mill, an Oregon-based whole grain foods manufacturer.

A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.

A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.

A quality improvement plan incorporating vaginal cleansing and azithromycin significantly reduced surgical-site infections (SSIs) after cesarean deliveries, reported Johanna Quist-Nelson, MD, of the University of North Carolina, Chapel Hill.

“Surgical site infections after a cesarean delivery are more common if the patient is in labor or has ruptured membranes,” she said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.. 

Two options to decrease the risk of SSIs after cesarean for those patients in labor or with ruptured membranes are vaginal cleansing and azithromycin, given in addition to preoperative antibiotics, Dr. Quist-Nelson said. She and her colleagues conducted a quality improvement study of the effects of a stepwise implementation of vaginal cleansing and azithromycin to reduce SSIs at cesarean delivery in this high-risk population. The data were collected from 2016 to 2019 at Thomas Jefferson University, Philadelphia.

“We aimed to decrease our SSI rate by 30% by adopting an intervention of cleansing followed by azithromycin,” she said.

The researchers added vaginal cleansing to the SSI prevention protocol in January 2017, with the addition of azithromycin in March 2018. Vaginal cleansing involved 30 seconds of anterior to posterior cleaning prior to urinary catheter placement. Azithromycin was given at a dose of 500 mg intravenously in addition to preoperative antibiotics and within an hour of cesarean delivery.

A total of 1,033 deliveries qualified for the study by being in labor or with ruptured membranes; of these 291 were performed prior to the interventions, 335 received vaginal cleansing only, and 407 received vaginal cleansing and azithromycin. The average age of the participants was 30 years; approximately 42% were Black, and 32% were White.
 

Cleansing protocol reduces SSIs

Overall, the rate of SSIs was 22% in the standard care group, 17% in the vaginal cleansing group, and 15% in the vaginal cleansing plus azithromycin group. When broken down by infection type, no deep SSI occurred in the vaginal cleansing or cleansing plus azithromycin group, compared with 2% of the standard care group (P = .009). In addition, endometritis, which is an organ-space SSI, was significantly lower in the cleansing group (10%) and the cleansing plus azithromycin group (11%), compared with the standard care group (16%).

The study findings were limited by factors including the use of EMRs for collection of data, and given that it is a quality improvement study, there is a potential lack of generalizability to other institutions. The study focused on patients at high risk for SSI and the use of the Plan-Do-Study-Act (PDSA) method of conducting the research, Dr. Quist-Nelson said. Compared with standard care, the implementation of vaginal cleansing reduced the SSI rate by 33%, with no significantly further change in SSI after the addition of azithromycin, she concluded.
 

Data sharing boosts compliance

In a question-and-answer session, Dr. Quist-Nelson noted that povidone iodine (Betadine) was chosen for vaginal cleansing because it was easily accessible at her institution, but that patients with allergies were given chlorhexidine. The cleansing itself was “primarily vaginal, not a full vulvar cleansing,” she clarified. The cleansing was performed immediately before catheter placement and included the urethra.

When asked about strategies to increase compliance, Dr. Quist-Nelson noted that sharing data was valuable, namely “reporting to our group the current compliance,” as well as sharing information by email and discussing it during multidisciplinary rounds.

The study was a quality improvement project and not a randomized trial, so the researchers were not able to tease out the impact of vaginal cleansing from the impact of azithromycin, Dr. Quist-Nelson said.

Based on her results, Dr. Quist-Nelson said she would recommend the protocol for use in patients who require cesarean delivery after being in labor or having ruptured membranes, and that “there are trials to support the use of both interventions.”

The results suggest opportunities for further randomized trials, including examination of the use of oral versus IV azithromycin, she added.

The study received no outside funding. Dr. Quist-Nelson had no financial conflicts to disclose.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Combination therapy with relugolix, an investigational oral gonadotropin-releasing hormone antagonist, estradiol, and norethindrone acetate effectively preserved bone mineral density (BMD) in two replicate phase 3 studies enrolling women with heavy menstrual bleeding associated with uterine fibroids.

The BMD findings, released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, build upon previously reported positive primary endpoint data from the LIBERTY 1 and LIBERTY 2 studies. ACOG canceled the meeting and released abstracts for press coverage.

The developer of the drug, Myovant Sciences, plans to submit a new drug application to the Food and Drug Administration for approval of the single-tablet combination therapy for women with uterine fibroids, according to Albert Liao, the company’s director of corporate communications.

The two multinational LIBERTY studies randomized women who had a monthly menstrual blood loss volume of at least 80 mL in two consecutive cycles (or 160 mL in one cycle) in a 1:1:1 ratio to one of three groups: relugolix combination therapy for 24 weeks (once-daily relugolix 40 mg plus estradiol 1.0 mg plus norethindrone acetate 0.5 mg); relugolix alone (40 mg once daily) for 12 weeks followed by relugolix combination therapy for 12 weeks; or placebo for 24 weeks.

In October 2019 at the American Society for Reproductive Medicine Scientific Congress, investigators reported that 73% of women receiving combination therapy in the LIBERTY 1 trial achieved a menstrual blood loss of less than 80 mL and a 50% or greater reduction from baseline over the last 35 days of treatment, compared with 19% in the placebo group. The mean percent reduction in menstrual blood loss from baseline at week 24 was 84% for combination therapy and 23% for placebo.

Earlier in 2019, Myovant Sciences announced that, in the LIBERTY 2 study, 71% of women receiving combination therapy met the primary endpoints, compared with 15% in the placebo group. The reduction in menstrual blood loss in this study’s combination therapy arm was also 84%, according to a company press release from June 2019.

Each of the two clinical trials enrolled upwards of 380 women.

The new abstract released for press coverage by ACOG and published in Obstetrics & Gynecology reports that women receiving relugolix combination therapy in the LIBERTY 1 and LIBERTY 2 studies had a mean change in lumbar spine BMD of –0.36% and –0.13%, respectively, from baseline to 24 weeks. Percent change in lumbar spine BMD in the delayed combination therapy groups (12 initial weeks of relugolix monotherapy) was –1.82% and –2.12%. In the placebo groups, the change was 0.05% and 0.32%.

Michael R. McClung, MD, who is the lead author of the abstract and was scheduled to present the findings at the ACOG meeting, said in an interview that the slight decreases in lumbar spine BMD with combination therapy were noted largely at week 12 and are “clinically insignificant in my opinion.” BMD by dual-energy x-ray absorptiometry was assessed at weeks 12 and 24.

“There was no further increase [after week 12] and [in some patients] there was even a return to baseline,” said Dr. McClung, of the Oregon Osteoporosis Center in Portland.

The safety and efficacy of longer-term treatment with relugolix combination therapy has been investigated thus far through an open-label extension study that brought the treatment period to 52 weeks. The 1-year data has been positive and will be presented or published soon, said Mr. Liao. In addition, a “second, 52-week randomized withdrawal study has been designed to provide 2-year safety and efficacy data … and to evaluate the need for maintenance therapy.”

It’s important, Dr. McClung said, “for clinicians to be confident that BMD loss is prevented or minimized with longer-term relugolix combination therapy since treatment for uterine fibroids is not a short-term proposition. Given the stability of BMD values between weeks 12 and 24 in the LIBERTY studies, I’d anticipate that we will see stable values with longer-term treatment.”

Dr. McClung disclosed that he has served as a consultant/advisory board member and speaker for Amgen and a consultant/advisory board member for Myovant. Several of his coauthors disclosed employment and ownerships interests in Myovant.

SOURCE: McClung MR et al. Obstet Gynecol. 2020 May. doi: 10.1097/01.AOG.0000662944.34860.b4.

Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

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.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

pdnews@mdedge.com

Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

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.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

pdnews@mdedge.com

Use of testicular sperm in nonazoospermic couples who had prior in vitro fertilization failure using ejaculated sperm appears to improve embryo development and rates of clinical pregnancy and live birth, a retrospective observational study has found.

©ktsimage/iStockphoto.com

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.

The study, which won the college’s Donald F. Richardson Memorial Prize Research Paper award, evaluated 112 nonazoospermic couples with an average of 2.3 failed in vitro fertilization (IVF) cycles (range of 1-8). The couples, patients at Shade Grove Fertility in Washington, underwent 157 total intracytoplasmic sperm injection (ICSI) cycles (133 using fresh testicular sperm and 24 using frozen/thawed sperm) and had a total of 101 embryo transfers.

Use of ICSI with testicular sperm compared with prior cycles using ejaculated sperm significantly improved blastocyst development (65% vs. 33%, P < .001), blastocyst conversion rates (67% vs. 35%, P < .001) and the number of embryos available for vitrification (1.6 vs. 0.7, P < .001). Fertilization rates were similar (70% vs. 58%). The clinical pregnancy and live birth rates in couples who used testicular sperm were 44% and 32%, respectively.

The findings suggest improved embryo development and pregnancy rates, and offer more evidence “that this might be something we can offer patients who’ve had multiple failures and no other reason as to why,” M. Blake Evans, DO, clinical fellow in reproductive endocrinology and infertility at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md., said in a interview. “It looks like there is promise, and we need more research to be conducted.”

The integration of the use of testicular sperm at Shady Grove, a private practice fertility center, and the newly completed analysis of outcomes, were driven by studies “showing that testicular sperm has a low DNA fragmentation index and suggesting that it [offers a] better chance of successful IVF outcomes in patients who have had prior failures,” he said.

Almost all of the men who had ICSC using testicular sperm – 105 of the 112 – had a sperm DNA fragmentation (SDF) assessment of their ejaculate sperm. The mean SDF was 32% and of these 105 men, 66 had an SDF greater than 25% (mean of 49%), a value considered abnormal. The outcomes for patients with elevated SDF did not differ significantly from the overall cohort, Dr. Evans and coinvestigators reported in their abstract.

Dr. Evans said that it’s too early to draw any conclusions about the utility of SDF testing, and that the investigators plan to start prospectively evaluating whether levels of sperm DNA damage as reflected in SDF testing correlate with IVF outcomes.

“Right now the evidence is so conflicting as to whether [SDF testing offers] information that all IVF patients or infertility patients should be receiving,” he said. “Is the reason that testicular sperm works better because there’s lower DNA fragmentation? We think so. … But now that we see [that it] appears the outcomes are better [using testicular sperm], we need to take it a step further and look prospectively at the impact of DNA fragmentation, comparing all the outcomes with normal and abnormal DNA [levels].”

Mark P. Trolice, MD, director of Fertility CARE: The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview that while “there is increasing evidence – and rather clear evidence – that testicular sperm has less DNA damage,” there has been controversy over available outcomes data, most of which have come from small, retrospective studies. Dr. Trolice was not involved in this study presented at ACOG.

In the case of “very poor outcomes with use of ejaculated sperm and a high SDF index, there seems to be support for the use of testicular sperm on the next IVF cycle,” he said. “But there’s also evidence to support that there’s no significant difference in the outcomes of IUI [intrauterine insemination] or IVF based on the SDF index. So this [study] really took a tremendous leap of faith.”

Dr. Trolice said he looks forward to more research – ideally prospective, randomized studies of men with high SDF levels who proceed with assisted reproductive technologies using ejaculated or testicular sperm.

The research was supported by the division of intramural research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Evans did not report any relevant financial disclosures. One of his coinvestigators. Micah J. Hill, DO, disclosed having served on the advisory board of Ohana Biosciences. Dr. Trolice reported that he has no relevant financial disclosures. He is a member of the Ob.Gyn. News editorial advisory board.

The abstract was first presented by coauthor Lt. Allison A. Eubanks, MD, of Walter Reed National Military Medical Center, at the ACOG Armed Forces District Annual District Meeting in September 2019.

pdnews@mdedge.com

Menopausal women with an intact uterus treated for a year with a daily, oral, single-pill formulation of estradiol and progesterone for the primary goal of reducing moderate to severe vasomotor symptoms showed evidence of reduced bone turnover in a post hoc, subgroup analysis of 157 women enrolled in the REPLENISH trial.

Ingram Publishing/Thinkstock

These findings “provide support for a potential skeletal benefit” when menopausal women with an intact uterus regularly used the tested estradiol plus progesterone formulation to treat moderate to severe vasomotor symptoms (VMS), Risa Kagan, MD, and associates wrote in an abstract 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.

The reductions reported for three different markers of bone turnover compared with placebo control after 6 and 12 months on treatment with a U.S.-marketed estradiol plus progesterone formulation were ”reassuring and in line with expectations” said Lubna Pal, MBBS, professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., who was not involved with the study. But the findings fell short of addressing the more clinically relevant issue of whether the tested regimen reduces the rate of bone fractures.

The analysis included 56 women treated with 1.0 mg estradiol and 100 mg progesterone daily, 56 who received 0.5 mg estradiol and 100 mg progesterone daily, and 45 women in the placebo arm. It assessed changes from baseline in the on-treatment compared with placebo groups using immunoassays for bone-specific alkaline phosphatase (BSAP), C-terminal telopeptide of type 1 collagen (CTX-1), and N-terminal propeptide of type 1 procollagen (PINP). For this analysis, the researchers combined the two active-treatment arms, and found that all three markers showed statistically significant drops from baseline with treatment, compared with placebo at both 6- and 12-month follow-up. For all three markers, the declines on active treatment grew larger with time, and after 12 months the mean drops from baseline compared with placebo were an 18% relative reduction in BSAP, a 41% relative reduction in CTX-1, and a 29% relative reduction in PINP, reported Dr. Kagan, a gynecologist based in Berkeley, Calif., who is affiliated with the University of California San Francisco.

In addition to not yet providing more clinically meaningful results on bone fracture rates, Dr. Pal cited additional issues that limit interpretation of both these findings and the broader REPLENISH results. First, the new analysis of bone-turnover markers as reported in the abstract does not allow assessment of a possible dose-dependent effect on bone turnover. More importantly, while the full REPLENISH trial provided reassuring data on endometrial protection, it has not yet reported data on the other major safety concern of hormone replacement: the effects of treatment on breast cancer rates. “They need to show no harm” in breast tissue, Dr. Pal said in an interview. In addition, the positive effect reported on markers of bone turnover is not unique to this formulation. Other formulations with estrogen at similar dosages would have similar effects, she said.

Other considerations when using an oral formulation include the reduced risk for prothrombotic effects from estradiol when delivered transdermally instead of orally, although some women have trouble getting insurance coverage for transdermal formulations, Dr. Pal said. Oral estrogen is appropriate only for women without an elevated clotting risk. Daily progesterone treatment also is more problematic than a cyclical dosage regimen, but noncontinuous progesterone results in monthly bleeding, something that some women prefer to avoid. “I’m not convinced that continuous progesterone is a physiologic approach,” said Dr. Pal, a member of the Ob.Gyn. News editorial advisory board. In addition, some women may find the formulation attractive because both the estradiol and progesterone are bioidentical and not synthetic molecules.

In short, the oral estradiol plus progesterone formulation tested in REPLENISH “is another tool” that’s an option for selected menopausal women with a uterus. “The bone findings are in line with expectations and are reassuring. Long-term data are keenly awaited to understand whether the bone marker changes lead to fewer fractures. The impact of the treatment on breast safety will be especially important.” For women who want a bioidentical, oral option and to not have bleeding, the tested formulation can be an effective option providing both symptom benefit and endometrial protection, Dr. Pal said.

REPLENISH was funded by TherapeuticsMD, the company that markets the tested estradiol plus progesterone formulation (Bijuva). Dr. Kagan has been a consultant and adviser to and speaker on behalf of Therapeutics MD, and she has also been a consultant or adviser to or has spoken on behalf of AMAG, Amgen, Astellas, Lupin, Radius, and Warner Chilcott/Allergan, and she has received research funding from Endoceutics. Dr. Pal has been a consultant to Flow Health.

mzoler@mdedge.com

SOURCE: Kagan R et al. Obstet Gynecol. 2020 May;135:62S. doi: 10.1097/01.AOG.0000665076.20231.a8.

Menopausal women with an intact uterus treated for a year with a daily, oral, single-pill formulation of estradiol and progesterone for the primary goal of reducing moderate to severe vasomotor symptoms showed evidence of reduced bone turnover in a post hoc, subgroup analysis of 157 women enrolled in the REPLENISH trial.

Ingram Publishing/Thinkstock

These findings “provide support for a potential skeletal benefit” when menopausal women with an intact uterus regularly used the tested estradiol plus progesterone formulation to treat moderate to severe vasomotor symptoms (VMS), Risa Kagan, MD, and associates wrote in an abstract 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.

The reductions reported for three different markers of bone turnover compared with placebo control after 6 and 12 months on treatment with a U.S.-marketed estradiol plus progesterone formulation were ”reassuring and in line with expectations” said Lubna Pal, MBBS, professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., who was not involved with the study. But the findings fell short of addressing the more clinically relevant issue of whether the tested regimen reduces the rate of bone fractures.

The analysis included 56 women treated with 1.0 mg estradiol and 100 mg progesterone daily, 56 who received 0.5 mg estradiol and 100 mg progesterone daily, and 45 women in the placebo arm. It assessed changes from baseline in the on-treatment compared with placebo groups using immunoassays for bone-specific alkaline phosphatase (BSAP), C-terminal telopeptide of type 1 collagen (CTX-1), and N-terminal propeptide of type 1 procollagen (PINP). For this analysis, the researchers combined the two active-treatment arms, and found that all three markers showed statistically significant drops from baseline with treatment, compared with placebo at both 6- and 12-month follow-up. For all three markers, the declines on active treatment grew larger with time, and after 12 months the mean drops from baseline compared with placebo were an 18% relative reduction in BSAP, a 41% relative reduction in CTX-1, and a 29% relative reduction in PINP, reported Dr. Kagan, a gynecologist based in Berkeley, Calif., who is affiliated with the University of California San Francisco.

In addition to not yet providing more clinically meaningful results on bone fracture rates, Dr. Pal cited additional issues that limit interpretation of both these findings and the broader REPLENISH results. First, the new analysis of bone-turnover markers as reported in the abstract does not allow assessment of a possible dose-dependent effect on bone turnover. More importantly, while the full REPLENISH trial provided reassuring data on endometrial protection, it has not yet reported data on the other major safety concern of hormone replacement: the effects of treatment on breast cancer rates. “They need to show no harm” in breast tissue, Dr. Pal said in an interview. In addition, the positive effect reported on markers of bone turnover is not unique to this formulation. Other formulations with estrogen at similar dosages would have similar effects, she said.

Other considerations when using an oral formulation include the reduced risk for prothrombotic effects from estradiol when delivered transdermally instead of orally, although some women have trouble getting insurance coverage for transdermal formulations, Dr. Pal said. Oral estrogen is appropriate only for women without an elevated clotting risk. Daily progesterone treatment also is more problematic than a cyclical dosage regimen, but noncontinuous progesterone results in monthly bleeding, something that some women prefer to avoid. “I’m not convinced that continuous progesterone is a physiologic approach,” said Dr. Pal, a member of the Ob.Gyn. News editorial advisory board. In addition, some women may find the formulation attractive because both the estradiol and progesterone are bioidentical and not synthetic molecules.

In short, the oral estradiol plus progesterone formulation tested in REPLENISH “is another tool” that’s an option for selected menopausal women with a uterus. “The bone findings are in line with expectations and are reassuring. Long-term data are keenly awaited to understand whether the bone marker changes lead to fewer fractures. The impact of the treatment on breast safety will be especially important.” For women who want a bioidentical, oral option and to not have bleeding, the tested formulation can be an effective option providing both symptom benefit and endometrial protection, Dr. Pal said.

REPLENISH was funded by TherapeuticsMD, the company that markets the tested estradiol plus progesterone formulation (Bijuva). Dr. Kagan has been a consultant and adviser to and speaker on behalf of Therapeutics MD, and she has also been a consultant or adviser to or has spoken on behalf of AMAG, Amgen, Astellas, Lupin, Radius, and Warner Chilcott/Allergan, and she has received research funding from Endoceutics. Dr. Pal has been a consultant to Flow Health.

mzoler@mdedge.com

SOURCE: Kagan R et al. Obstet Gynecol. 2020 May;135:62S. doi: 10.1097/01.AOG.0000665076.20231.a8.

Menopausal women with an intact uterus treated for a year with a daily, oral, single-pill formulation of estradiol and progesterone for the primary goal of reducing moderate to severe vasomotor symptoms showed evidence of reduced bone turnover in a post hoc, subgroup analysis of 157 women enrolled in the REPLENISH trial.

Ingram Publishing/Thinkstock

These findings “provide support for a potential skeletal benefit” when menopausal women with an intact uterus regularly used the tested estradiol plus progesterone formulation to treat moderate to severe vasomotor symptoms (VMS), Risa Kagan, MD, and associates wrote in an abstract 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.

The reductions reported for three different markers of bone turnover compared with placebo control after 6 and 12 months on treatment with a U.S.-marketed estradiol plus progesterone formulation were ”reassuring and in line with expectations” said Lubna Pal, MBBS, professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., who was not involved with the study. But the findings fell short of addressing the more clinically relevant issue of whether the tested regimen reduces the rate of bone fractures.

The analysis included 56 women treated with 1.0 mg estradiol and 100 mg progesterone daily, 56 who received 0.5 mg estradiol and 100 mg progesterone daily, and 45 women in the placebo arm. It assessed changes from baseline in the on-treatment compared with placebo groups using immunoassays for bone-specific alkaline phosphatase (BSAP), C-terminal telopeptide of type 1 collagen (CTX-1), and N-terminal propeptide of type 1 procollagen (PINP). For this analysis, the researchers combined the two active-treatment arms, and found that all three markers showed statistically significant drops from baseline with treatment, compared with placebo at both 6- and 12-month follow-up. For all three markers, the declines on active treatment grew larger with time, and after 12 months the mean drops from baseline compared with placebo were an 18% relative reduction in BSAP, a 41% relative reduction in CTX-1, and a 29% relative reduction in PINP, reported Dr. Kagan, a gynecologist based in Berkeley, Calif., who is affiliated with the University of California San Francisco.

In addition to not yet providing more clinically meaningful results on bone fracture rates, Dr. Pal cited additional issues that limit interpretation of both these findings and the broader REPLENISH results. First, the new analysis of bone-turnover markers as reported in the abstract does not allow assessment of a possible dose-dependent effect on bone turnover. More importantly, while the full REPLENISH trial provided reassuring data on endometrial protection, it has not yet reported data on the other major safety concern of hormone replacement: the effects of treatment on breast cancer rates. “They need to show no harm” in breast tissue, Dr. Pal said in an interview. In addition, the positive effect reported on markers of bone turnover is not unique to this formulation. Other formulations with estrogen at similar dosages would have similar effects, she said.

Other considerations when using an oral formulation include the reduced risk for prothrombotic effects from estradiol when delivered transdermally instead of orally, although some women have trouble getting insurance coverage for transdermal formulations, Dr. Pal said. Oral estrogen is appropriate only for women without an elevated clotting risk. Daily progesterone treatment also is more problematic than a cyclical dosage regimen, but noncontinuous progesterone results in monthly bleeding, something that some women prefer to avoid. “I’m not convinced that continuous progesterone is a physiologic approach,” said Dr. Pal, a member of the Ob.Gyn. News editorial advisory board. In addition, some women may find the formulation attractive because both the estradiol and progesterone are bioidentical and not synthetic molecules.

In short, the oral estradiol plus progesterone formulation tested in REPLENISH “is another tool” that’s an option for selected menopausal women with a uterus. “The bone findings are in line with expectations and are reassuring. Long-term data are keenly awaited to understand whether the bone marker changes lead to fewer fractures. The impact of the treatment on breast safety will be especially important.” For women who want a bioidentical, oral option and to not have bleeding, the tested formulation can be an effective option providing both symptom benefit and endometrial protection, Dr. Pal said.

REPLENISH was funded by TherapeuticsMD, the company that markets the tested estradiol plus progesterone formulation (Bijuva). Dr. Kagan has been a consultant and adviser to and speaker on behalf of Therapeutics MD, and she has also been a consultant or adviser to or has spoken on behalf of AMAG, Amgen, Astellas, Lupin, Radius, and Warner Chilcott/Allergan, and she has received research funding from Endoceutics. Dr. Pal has been a consultant to Flow Health.

mzoler@mdedge.com

SOURCE: Kagan R et al. Obstet Gynecol. 2020 May;135:62S. doi: 10.1097/01.AOG.0000665076.20231.a8.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

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.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

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.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

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.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.