Women's Health

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

Hypertensive disorders in pregnancy affect nearly 16% of women who give birth in U.S. hospitals and appear to be increasing, according to an April 29 report from the Centers for Disease Control and Prevention.

Older patients and Black women are substantially more likely to experience hypertension in pregnancy, the analysis found.

“Addressing hypertensive disorders in pregnancy is a key strategy in reducing inequities in pregnancy-related mortality,” study coauthor Wanda Barfield, MD, MPH, director of CDC’s Division of Reproductive Health, said in a statement.
 

Age, obesity, diabetes

The overall prevalence of hypertensive disorders in pregnancy increased from 13.3% in 2017 to 15.9% in 2019, the researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

The uptick in hypertension coincides with trends toward older maternal age and higher rates of obesity and diabetes, which may explain the increase, they said.

For the study, Dr. Barfield and her colleagues analyzed nationally representative data from the National Inpatient Sample. They identified patients with a diagnosis of chronic hypertension, pregnancy-associated hypertension, or unspecified maternal hypertension during their hospitalization.

Among women aged 45-55 years, the prevalence of hypertension was 31%. Among those aged 35-44 years, it was 18%.

Hypertension diagnoses were more common in women who were Black (20.9%) or American Indian or Alaska Native (16.4%), than in other groups.

Of patients who died during delivery hospitalization, 31.6% had a hypertensive disorder.

The study shows a marked increase in hypertensive disorders over a relatively short time, according to Jane van Dis, MD, of the department of obstetrics and gynecology at the University of Rochester (N.Y.), who was not involved in the research. The phenomenon is consistent with her own experience, she said.

“When I am admitting patients, I’m oftentimes surprised when someone does not have a hypertensive disorder because I feel like the majority of patients these days do,” Dr. van Dis told this news organization.

Dr. Van Dis speculated that factors related to the environment, including air pollution and endocrine disrupters, could contribute to elevated rates of hypertensive disorders.

Natalie Bello, MD, MPH, director of hypertension research at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said rates of hypertension today could be even higher than in the study.

The CDC report relied on pre-COVID data, and the pandemic “increased disparities in health outcomes,” Dr. Bello said in an interview. “I’m worried that in actuality these numbers are an underestimation of the current state of hypertension in pregnancy.”

Dr. Bello, who has studied the need for better training in cardio-obstetrics, applauded Vice President Kamala Harris’ efforts to improve maternal health.

“The racial and geographic disparities that we continue to see in the field are disheartening but should be a call to action to redouble our work to improve maternal outcomes,” Dr. Bello told this news organization. “The good news is that a lot of morbidity related to hypertension can be avoided with timely diagnosis and treatment of blood pressure. However, we need to act to provide all pregnant persons with optimal care.”

Janet Wright, MD, director of CDC’s Division for Heart Disease and Stroke Prevention, said blood pressure home monitoring is a “great example” of a strategy clinicians can use to identify and manage patients with hypertension.

But one approach – self-monitoring blood pressure from home during pregnancy – did not significantly improve the health of pregnant women, according to new results from randomized trials in the United Kingdom.

Trial results published in JAMA show that blood pressure home-monitoring coupled to telemonitoring, as compared with usual care, did not significantly improve blood pressure control among patients with chronic or gestational hypertension.

A second trial published in JAMA that included patients at risk for preeclampsia found that self-monitoring with telemonitoring did not lead to significantly earlier diagnoses of hypertension.

“Individuals at risk for a hypertensive disorder of pregnancy, or with gestational or chronic hypertension, cannot be treated with a single approach,” Malavika Prabhu, MD, with Weill Cornell Medicine, New York, and coauthors write in an editorial accompanying the JAMA studies. Although the data suggest that self-monitoring of blood pressure is practical and tolerated, “More research is needed to determine optimal, high-value, equitable approaches to averting adverse perinatal outcomes associated with hypertensive disorders of pregnancy,” they write.

The CDC study authors and Dr. van Dis have disclosed no relevant financial relationships. Dr. Bello is funded by the National Institutes of Health to study blood pressure monitoring in pregnancy. The JAMA editorial authors disclosed university, government, and corporate grants and work with publishing companies.

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

BOZEMAN, Mont. – In a busy downtown coffee shop, a drawing of a ski lift with intrauterine devices for chairs draws the eyes of sleepy customers getting their morning underway with a caffeine jolt.

The flyer touts the services of Bridgercare, a nonprofit reproductive health clinic a few miles up the road. The clinic offers wellness exams, birth control, and LGBTQ+ services – and, starting in April, it oversees the state’s multimillion-dollar share of federal family planning program funding.

In March, Bridgercare beat out the state health department to become administrator of Montana’s $2.3 million Title X program, which helps pay for family planning and preventive health services. The organization applied for the grant because its leaders were concerned about a new state law that sought to restrict which local providers are funded.

What is happening in Montana is the latest example of an ongoing power struggle between nonprofits and conservative-leaning states over who receives federal family planning money. That has intensified in recent years as the Title X program has increasingly become entangled with the politics of abortion.

This year, the federal government set aside $257 million for family planning and preventive care. The providers that get that funding often serve families with low incomes, and Title X is one of the few federal programs in which people without legal permission to be in the United States can participate.

“The program permeates into communities that otherwise would be unreached by public health efforts,” said Rebecca Kreitzer, an associate professor of public policy at the University of North Carolina at Chapel Hill.

The Montana Department of Public Health and Human Services controlled the distribution of the state’s Title X funds for decades. Bridgercare sought the administrator role to circumvent a Republican-sponsored law passed last year that required the state to prioritize the money for local health departments and federally qualified health centers. That would have put the nonprofit – which doesn’t provide abortion procedures – and similar organizations at the bottom of the list. The law also banned clinics that perform abortions from receiving Title X funds from the state health department.

Bridgercare Executive Director Stephanie McDowell said the group applied for the grant to try to protect the program from decisions coming out of the state capitol. “Because of the politicization of Title X, we’re seeing how it’s run, swinging back and forth based on partisan leadership,” Ms. McDowell said.

A U.S. Department of Health & Human Services spokesperson, Tara Broido, didn’t answer a question about whether the agency intentionally awarded grants to nonprofits to avoid state politics. Instead, she said in a statement that applicants were evaluated in a competitive process by a panel of independent reviewers based on criteria to deliver high-quality, client-centered services.

Federal law prohibits the money from being used to perform abortions. But it can cover other services provided by groups that offer abortions – the largest and best-known by far is Planned Parenthood. In recent years, conservative politicians have tried to keep such providers from receiving Title X funding.

In some cases, contraception has entered the debate around which family planning services government should help fund. Some abortion opponents have raised concerns that long-lasting forms of birth control, such as IUDs, lead to abortions. Those claims are disputed by reproductive health experts.

In 2019, the Trump administration introduced several new rules for Title X, including disqualifying from receiving the funding family planning clinics that also offered abortion services or referrals. Many clinics across the nation left the program instead of conforming to the rules. Simultaneously, the spread of COVID-19 interrupted routine care. The number of patients served by Title X plummeted.

The Biden administration reversed most of those rules, including allowing providers with abortion services back into the Title X program. States also try to influence the funding’s reach, either through legislation or budget rules.

The current Title X funding cycle is 5 years, and the amount of money available each year could shift based on the state’s network of providers or federal budget changes. Jon Ebelt, a spokesperson for the Montana Department of Public Health and Human Services, didn’t answer when asked whether the state planned to reapply to administer the funding in 2027. He said the department was disappointed with the Biden administration’s “refusal” to renew the state’s funding.

“We recognize, however, that recent proabortion federal rule changes have distorted Title X and conflict with Montana law,” he said.

Conservative states have been tangling with nonprofits and the federal government over Title X funding for more than a decade. In 2011, during the Obama administration, Texas whittled down the state’s family planning spending and prioritized sending the federal money to general primary care providers over reproductive health clinics. As a result, 25% of family planning clinics in Texas closed. In 2013, a nonprofit now called Every Body Texas joined the competition to distribute the state’s Title X dollars and won.

“Filling and rebuilding those holes have taken this last decade, essentially,” said Berna Mason, director of service delivery improvement for Every Body Texas.

In 2019, the governor of Nebraska proposed a budget that would have prohibited the money from going to any organization that provided abortions or referred patients for abortions outside of an emergency. It also would have required that funding recipients be legally and financially separate from such clinics, a restriction that would have gone further than the Trump administration’s rules. Afterward, a family planning council won the right to administer Title X money.

In 2017, the nonprofit Arizona Family Health Partnership lost its status as that state’s only Title X administrator when the state health department was given 25% of the funding to deliver to providers. That came after Arizona lawmakers ordered the department to apply for the funds and distribute them first to state- or county-owned clinics, with the remaining money going to primary care facilities. The change was backed by groups that were opposed to abortion, and reproductive health care providers saw it as an attempt to weaken clinics that offer abortion services.

However, the state left nearly all the money it received untouched, and although it’s still required by law to apply for Title X funding, it hasn’t received a portion of the grant since.

Bré Thomas, CEO of Arizona Family Health Partnership, said that, even though the nonprofit is the sole administrator of the Title X funding again, the threat remains that some or all could be taken away because of politics. “We’re at the will of who’s in charge,” Ms. Thomas said.

Nonprofits say they have an advantage over state agencies in expanding services because they have more flexibility in fundraising and fewer administrative hurdles.

In April, Mississippi nonprofit Converge took over administration of Title X funds, a role the state had held for decades. The organization’s founders said they weren’t worried that conservative politicians would restrict access to services but simply believed they could do a better job. “Service quality was very low, and it was very hard to get appointments,” said cofounder Danielle Lampton.

A Mississippi State Department of Health spokesperson, Liz Sharlot, said the agency looks forward to working with Converge.

In Montana, Bridgercare plans to restore funding to Planned Parenthood clinics that have been cut off from the program since 2019, recruit more health centers to participate, and expand the program’s reach in rural, frontier, and tribal communities using telehealth services, Ms. McDowell said.

The organization’s goal is to increase the number of patients benefiting from the federal program by at least 10% in each year of the 5-year grant cycle. The clinic also plans to apply to keep its Title X role beyond this grant.

“In 5 years, our grant application should be a clear front-runner for funding,” she said. “It’s less about ‘How do we beat someone in 5 years?’ And more about ‘How do we grow this program to serve patients?’”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

BOZEMAN, Mont. – In a busy downtown coffee shop, a drawing of a ski lift with intrauterine devices for chairs draws the eyes of sleepy customers getting their morning underway with a caffeine jolt.

The flyer touts the services of Bridgercare, a nonprofit reproductive health clinic a few miles up the road. The clinic offers wellness exams, birth control, and LGBTQ+ services – and, starting in April, it oversees the state’s multimillion-dollar share of federal family planning program funding.

In March, Bridgercare beat out the state health department to become administrator of Montana’s $2.3 million Title X program, which helps pay for family planning and preventive health services. The organization applied for the grant because its leaders were concerned about a new state law that sought to restrict which local providers are funded.

What is happening in Montana is the latest example of an ongoing power struggle between nonprofits and conservative-leaning states over who receives federal family planning money. That has intensified in recent years as the Title X program has increasingly become entangled with the politics of abortion.

This year, the federal government set aside $257 million for family planning and preventive care. The providers that get that funding often serve families with low incomes, and Title X is one of the few federal programs in which people without legal permission to be in the United States can participate.

“The program permeates into communities that otherwise would be unreached by public health efforts,” said Rebecca Kreitzer, an associate professor of public policy at the University of North Carolina at Chapel Hill.

The Montana Department of Public Health and Human Services controlled the distribution of the state’s Title X funds for decades. Bridgercare sought the administrator role to circumvent a Republican-sponsored law passed last year that required the state to prioritize the money for local health departments and federally qualified health centers. That would have put the nonprofit – which doesn’t provide abortion procedures – and similar organizations at the bottom of the list. The law also banned clinics that perform abortions from receiving Title X funds from the state health department.

Bridgercare Executive Director Stephanie McDowell said the group applied for the grant to try to protect the program from decisions coming out of the state capitol. “Because of the politicization of Title X, we’re seeing how it’s run, swinging back and forth based on partisan leadership,” Ms. McDowell said.

A U.S. Department of Health & Human Services spokesperson, Tara Broido, didn’t answer a question about whether the agency intentionally awarded grants to nonprofits to avoid state politics. Instead, she said in a statement that applicants were evaluated in a competitive process by a panel of independent reviewers based on criteria to deliver high-quality, client-centered services.

Federal law prohibits the money from being used to perform abortions. But it can cover other services provided by groups that offer abortions – the largest and best-known by far is Planned Parenthood. In recent years, conservative politicians have tried to keep such providers from receiving Title X funding.

In some cases, contraception has entered the debate around which family planning services government should help fund. Some abortion opponents have raised concerns that long-lasting forms of birth control, such as IUDs, lead to abortions. Those claims are disputed by reproductive health experts.

In 2019, the Trump administration introduced several new rules for Title X, including disqualifying from receiving the funding family planning clinics that also offered abortion services or referrals. Many clinics across the nation left the program instead of conforming to the rules. Simultaneously, the spread of COVID-19 interrupted routine care. The number of patients served by Title X plummeted.

The Biden administration reversed most of those rules, including allowing providers with abortion services back into the Title X program. States also try to influence the funding’s reach, either through legislation or budget rules.

The current Title X funding cycle is 5 years, and the amount of money available each year could shift based on the state’s network of providers or federal budget changes. Jon Ebelt, a spokesperson for the Montana Department of Public Health and Human Services, didn’t answer when asked whether the state planned to reapply to administer the funding in 2027. He said the department was disappointed with the Biden administration’s “refusal” to renew the state’s funding.

“We recognize, however, that recent proabortion federal rule changes have distorted Title X and conflict with Montana law,” he said.

Conservative states have been tangling with nonprofits and the federal government over Title X funding for more than a decade. In 2011, during the Obama administration, Texas whittled down the state’s family planning spending and prioritized sending the federal money to general primary care providers over reproductive health clinics. As a result, 25% of family planning clinics in Texas closed. In 2013, a nonprofit now called Every Body Texas joined the competition to distribute the state’s Title X dollars and won.

“Filling and rebuilding those holes have taken this last decade, essentially,” said Berna Mason, director of service delivery improvement for Every Body Texas.

In 2019, the governor of Nebraska proposed a budget that would have prohibited the money from going to any organization that provided abortions or referred patients for abortions outside of an emergency. It also would have required that funding recipients be legally and financially separate from such clinics, a restriction that would have gone further than the Trump administration’s rules. Afterward, a family planning council won the right to administer Title X money.

In 2017, the nonprofit Arizona Family Health Partnership lost its status as that state’s only Title X administrator when the state health department was given 25% of the funding to deliver to providers. That came after Arizona lawmakers ordered the department to apply for the funds and distribute them first to state- or county-owned clinics, with the remaining money going to primary care facilities. The change was backed by groups that were opposed to abortion, and reproductive health care providers saw it as an attempt to weaken clinics that offer abortion services.

However, the state left nearly all the money it received untouched, and although it’s still required by law to apply for Title X funding, it hasn’t received a portion of the grant since.

Bré Thomas, CEO of Arizona Family Health Partnership, said that, even though the nonprofit is the sole administrator of the Title X funding again, the threat remains that some or all could be taken away because of politics. “We’re at the will of who’s in charge,” Ms. Thomas said.

Nonprofits say they have an advantage over state agencies in expanding services because they have more flexibility in fundraising and fewer administrative hurdles.

In April, Mississippi nonprofit Converge took over administration of Title X funds, a role the state had held for decades. The organization’s founders said they weren’t worried that conservative politicians would restrict access to services but simply believed they could do a better job. “Service quality was very low, and it was very hard to get appointments,” said cofounder Danielle Lampton.

A Mississippi State Department of Health spokesperson, Liz Sharlot, said the agency looks forward to working with Converge.

In Montana, Bridgercare plans to restore funding to Planned Parenthood clinics that have been cut off from the program since 2019, recruit more health centers to participate, and expand the program’s reach in rural, frontier, and tribal communities using telehealth services, Ms. McDowell said.

The organization’s goal is to increase the number of patients benefiting from the federal program by at least 10% in each year of the 5-year grant cycle. The clinic also plans to apply to keep its Title X role beyond this grant.

“In 5 years, our grant application should be a clear front-runner for funding,” she said. “It’s less about ‘How do we beat someone in 5 years?’ And more about ‘How do we grow this program to serve patients?’”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

BOZEMAN, Mont. – In a busy downtown coffee shop, a drawing of a ski lift with intrauterine devices for chairs draws the eyes of sleepy customers getting their morning underway with a caffeine jolt.

The flyer touts the services of Bridgercare, a nonprofit reproductive health clinic a few miles up the road. The clinic offers wellness exams, birth control, and LGBTQ+ services – and, starting in April, it oversees the state’s multimillion-dollar share of federal family planning program funding.

In March, Bridgercare beat out the state health department to become administrator of Montana’s $2.3 million Title X program, which helps pay for family planning and preventive health services. The organization applied for the grant because its leaders were concerned about a new state law that sought to restrict which local providers are funded.

What is happening in Montana is the latest example of an ongoing power struggle between nonprofits and conservative-leaning states over who receives federal family planning money. That has intensified in recent years as the Title X program has increasingly become entangled with the politics of abortion.

This year, the federal government set aside $257 million for family planning and preventive care. The providers that get that funding often serve families with low incomes, and Title X is one of the few federal programs in which people without legal permission to be in the United States can participate.

“The program permeates into communities that otherwise would be unreached by public health efforts,” said Rebecca Kreitzer, an associate professor of public policy at the University of North Carolina at Chapel Hill.

The Montana Department of Public Health and Human Services controlled the distribution of the state’s Title X funds for decades. Bridgercare sought the administrator role to circumvent a Republican-sponsored law passed last year that required the state to prioritize the money for local health departments and federally qualified health centers. That would have put the nonprofit – which doesn’t provide abortion procedures – and similar organizations at the bottom of the list. The law also banned clinics that perform abortions from receiving Title X funds from the state health department.

Bridgercare Executive Director Stephanie McDowell said the group applied for the grant to try to protect the program from decisions coming out of the state capitol. “Because of the politicization of Title X, we’re seeing how it’s run, swinging back and forth based on partisan leadership,” Ms. McDowell said.

A U.S. Department of Health & Human Services spokesperson, Tara Broido, didn’t answer a question about whether the agency intentionally awarded grants to nonprofits to avoid state politics. Instead, she said in a statement that applicants were evaluated in a competitive process by a panel of independent reviewers based on criteria to deliver high-quality, client-centered services.

Federal law prohibits the money from being used to perform abortions. But it can cover other services provided by groups that offer abortions – the largest and best-known by far is Planned Parenthood. In recent years, conservative politicians have tried to keep such providers from receiving Title X funding.

In some cases, contraception has entered the debate around which family planning services government should help fund. Some abortion opponents have raised concerns that long-lasting forms of birth control, such as IUDs, lead to abortions. Those claims are disputed by reproductive health experts.

In 2019, the Trump administration introduced several new rules for Title X, including disqualifying from receiving the funding family planning clinics that also offered abortion services or referrals. Many clinics across the nation left the program instead of conforming to the rules. Simultaneously, the spread of COVID-19 interrupted routine care. The number of patients served by Title X plummeted.

The Biden administration reversed most of those rules, including allowing providers with abortion services back into the Title X program. States also try to influence the funding’s reach, either through legislation or budget rules.

The current Title X funding cycle is 5 years, and the amount of money available each year could shift based on the state’s network of providers or federal budget changes. Jon Ebelt, a spokesperson for the Montana Department of Public Health and Human Services, didn’t answer when asked whether the state planned to reapply to administer the funding in 2027. He said the department was disappointed with the Biden administration’s “refusal” to renew the state’s funding.

“We recognize, however, that recent proabortion federal rule changes have distorted Title X and conflict with Montana law,” he said.

Conservative states have been tangling with nonprofits and the federal government over Title X funding for more than a decade. In 2011, during the Obama administration, Texas whittled down the state’s family planning spending and prioritized sending the federal money to general primary care providers over reproductive health clinics. As a result, 25% of family planning clinics in Texas closed. In 2013, a nonprofit now called Every Body Texas joined the competition to distribute the state’s Title X dollars and won.

“Filling and rebuilding those holes have taken this last decade, essentially,” said Berna Mason, director of service delivery improvement for Every Body Texas.

In 2019, the governor of Nebraska proposed a budget that would have prohibited the money from going to any organization that provided abortions or referred patients for abortions outside of an emergency. It also would have required that funding recipients be legally and financially separate from such clinics, a restriction that would have gone further than the Trump administration’s rules. Afterward, a family planning council won the right to administer Title X money.

In 2017, the nonprofit Arizona Family Health Partnership lost its status as that state’s only Title X administrator when the state health department was given 25% of the funding to deliver to providers. That came after Arizona lawmakers ordered the department to apply for the funds and distribute them first to state- or county-owned clinics, with the remaining money going to primary care facilities. The change was backed by groups that were opposed to abortion, and reproductive health care providers saw it as an attempt to weaken clinics that offer abortion services.

However, the state left nearly all the money it received untouched, and although it’s still required by law to apply for Title X funding, it hasn’t received a portion of the grant since.

Bré Thomas, CEO of Arizona Family Health Partnership, said that, even though the nonprofit is the sole administrator of the Title X funding again, the threat remains that some or all could be taken away because of politics. “We’re at the will of who’s in charge,” Ms. Thomas said.

Nonprofits say they have an advantage over state agencies in expanding services because they have more flexibility in fundraising and fewer administrative hurdles.

In April, Mississippi nonprofit Converge took over administration of Title X funds, a role the state had held for decades. The organization’s founders said they weren’t worried that conservative politicians would restrict access to services but simply believed they could do a better job. “Service quality was very low, and it was very hard to get appointments,” said cofounder Danielle Lampton.

A Mississippi State Department of Health spokesperson, Liz Sharlot, said the agency looks forward to working with Converge.

In Montana, Bridgercare plans to restore funding to Planned Parenthood clinics that have been cut off from the program since 2019, recruit more health centers to participate, and expand the program’s reach in rural, frontier, and tribal communities using telehealth services, Ms. McDowell said.

The organization’s goal is to increase the number of patients benefiting from the federal program by at least 10% in each year of the 5-year grant cycle. The clinic also plans to apply to keep its Title X role beyond this grant.

“In 5 years, our grant application should be a clear front-runner for funding,” she said. “It’s less about ‘How do we beat someone in 5 years?’ And more about ‘How do we grow this program to serve patients?’”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Mental disorders were significantly more likely in children whose mothers had one of five common autoimmune diseases, a new study found.

Previous research has linked both maternal and paternal autoimmune diseases and specific mental disorders, such as attention-deficit/hyperactivity disorder (ADHD), but most of these studies focused on specific conditions in relatively small populations. The new study included data on more than 2 million births, making it one of the largest efforts to date to examine the association, according to the researchers, whose findings were published in JAMA Network Open.

Previous evidence of the possible association between certain maternal autoimmune diseases and mental disorders in offspring has been “scattered and limited,” which “hampered an overall understanding” of the link, Fei Li, MD, the corresponding author of the study, told this news organization.

Dr. Li, of Shanghai Jiao Tong University China, and colleagues reviewed data from a Danish registry cohort of singleton births with up to 38 years of follow-up. They explored associations between a range of maternal autoimmune diseases diagnosed before childbirth and the risks of mental disorders in children in early childhood through young adulthood.

The study population included 2,254,234 births and 38,916,359 person-years. Data on mental health were collected from the Psychiatric Central Research Register and the country’s National Patient Register. The median age of the children at the time of assessment was 16.7 years; approximately half were male.

A total of 50,863 children (2.26%) were born to mothers who had been diagnosed with autoimmune diseases before childbirth. During the follow-up period, 5,460 children of mothers with autoimmune diseases and 303,092 children of mothers without autoimmune diseases were diagnosed with a mental disorder (10.73% vs. 13.76%), according to the researchers.

The risk of being diagnosed with a mental disorder was significantly higher among children of mothers with any autoimmune disease (hazard ratio [HR,], 1.16), with an incidence of 9.38 vs. 7.91 per 1,000 person-years, the researchers reported.

The increased risk persisted when the results were classified by organ system, including connective tissue (HR, 1.11), endocrine (HR, 1.19), gastrointestinal (HR, 1.11), blood (HR, 1.10), nervous (HR, 1.17), and skin (HR, 1.19).

The five autoimmune diseases in mothers that were most commonly associated mental health disorders in children were type 1 diabetes, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and psoriasis vulgaris.

The greatest risk for children of mothers with any autoimmune disease was observed for organic conditions such as delirium, (HR, 1.54), followed by obsessive-compulsive disorder (HR, 1.42), schizophrenia (HR, 1.54), and mood problems (HR, 1.12).

Children of mothers with any autoimmune disorder also had a significantly increased risk of autism (HR, 1.21), intellectual disability (HR, 1.19), and ADHD (HR, 1.19).

The results add to evidence that activation of the maternal immune system may drive changes in the brain and behavioral problems, which has been observed in animal studies, the researchers wrote.

Potential underlying mechanisms in need of more exploration include genetic risk factors, maternal transmission of autoantibodies to the fetus during pregnancy, and the increased risk of obstetric complications, such as preterm birth, for women with autoimmune disorders that could affect mental development in children, they added.

The study findings were limited by several factors, including the lack of data on potential exacerbation of autoimmune disease activity during pregnancy and its effect on the fetus, the researchers noted. Other limitations included potential detection bias, lack of data on mental disorders in adulthood, and potential changes in diagnostic criteria over the long study period.

The results were strengthened by the use of a population-based registry, the large sample size, and ability to consider a range of confounders, the researchers said.

“This study could help acquire a comprehensive compilation of the associations between maternal autoimmune disorders diagnosed before childbirth and offspring’s mental disorders from childhood through early adulthood,” Dr. Li said in an interview.

For clinicians, Dr. Li said, the findings suggest that the offspring of mothers with autoimmune diseases may benefit from long-term surveillance for mental health disorders.

“Further studies should provide more evidence on the detailed associations of specific maternal autoimmune diseases with a full spectrum of mental disorders in offspring, and more research on underlying mechanisms is needed as well,” she said.
 

Pay early attention

M. Susan Jay, MD, an adjunct professor of pediatrics at the Medical College of Wisconsin, Milwaukee, said previous efforts to examine the association between maternal autoimmunity were hampered by study design, small samples, and self-report of disease history – problems the new research avoids.

The large patient population allowed for detailed subgroup analysis of different conditions and outcomes. Another advantage was the availability of sociodemographic and clinical information, which allowed for the elimination of confounding factors, said Dr. Jay, who was not involved in the research.

“It would be prudent to follow children of mothers with autoimmune disorders before or during pregnancy for mental health issues, and if identified clinically, to offer psychological and developmental behavioral support options,” Dr. Jay added.

The authors have reported no relevant financial relationships.

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

Mental disorders were significantly more likely in children whose mothers had one of five common autoimmune diseases, a new study found.

Previous research has linked both maternal and paternal autoimmune diseases and specific mental disorders, such as attention-deficit/hyperactivity disorder (ADHD), but most of these studies focused on specific conditions in relatively small populations. The new study included data on more than 2 million births, making it one of the largest efforts to date to examine the association, according to the researchers, whose findings were published in JAMA Network Open.

Previous evidence of the possible association between certain maternal autoimmune diseases and mental disorders in offspring has been “scattered and limited,” which “hampered an overall understanding” of the link, Fei Li, MD, the corresponding author of the study, told this news organization.

Dr. Li, of Shanghai Jiao Tong University China, and colleagues reviewed data from a Danish registry cohort of singleton births with up to 38 years of follow-up. They explored associations between a range of maternal autoimmune diseases diagnosed before childbirth and the risks of mental disorders in children in early childhood through young adulthood.

The study population included 2,254,234 births and 38,916,359 person-years. Data on mental health were collected from the Psychiatric Central Research Register and the country’s National Patient Register. The median age of the children at the time of assessment was 16.7 years; approximately half were male.

A total of 50,863 children (2.26%) were born to mothers who had been diagnosed with autoimmune diseases before childbirth. During the follow-up period, 5,460 children of mothers with autoimmune diseases and 303,092 children of mothers without autoimmune diseases were diagnosed with a mental disorder (10.73% vs. 13.76%), according to the researchers.

The risk of being diagnosed with a mental disorder was significantly higher among children of mothers with any autoimmune disease (hazard ratio [HR,], 1.16), with an incidence of 9.38 vs. 7.91 per 1,000 person-years, the researchers reported.

The increased risk persisted when the results were classified by organ system, including connective tissue (HR, 1.11), endocrine (HR, 1.19), gastrointestinal (HR, 1.11), blood (HR, 1.10), nervous (HR, 1.17), and skin (HR, 1.19).

The five autoimmune diseases in mothers that were most commonly associated mental health disorders in children were type 1 diabetes, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and psoriasis vulgaris.

The greatest risk for children of mothers with any autoimmune disease was observed for organic conditions such as delirium, (HR, 1.54), followed by obsessive-compulsive disorder (HR, 1.42), schizophrenia (HR, 1.54), and mood problems (HR, 1.12).

Children of mothers with any autoimmune disorder also had a significantly increased risk of autism (HR, 1.21), intellectual disability (HR, 1.19), and ADHD (HR, 1.19).

The results add to evidence that activation of the maternal immune system may drive changes in the brain and behavioral problems, which has been observed in animal studies, the researchers wrote.

Potential underlying mechanisms in need of more exploration include genetic risk factors, maternal transmission of autoantibodies to the fetus during pregnancy, and the increased risk of obstetric complications, such as preterm birth, for women with autoimmune disorders that could affect mental development in children, they added.

The study findings were limited by several factors, including the lack of data on potential exacerbation of autoimmune disease activity during pregnancy and its effect on the fetus, the researchers noted. Other limitations included potential detection bias, lack of data on mental disorders in adulthood, and potential changes in diagnostic criteria over the long study period.

The results were strengthened by the use of a population-based registry, the large sample size, and ability to consider a range of confounders, the researchers said.

“This study could help acquire a comprehensive compilation of the associations between maternal autoimmune disorders diagnosed before childbirth and offspring’s mental disorders from childhood through early adulthood,” Dr. Li said in an interview.

For clinicians, Dr. Li said, the findings suggest that the offspring of mothers with autoimmune diseases may benefit from long-term surveillance for mental health disorders.

“Further studies should provide more evidence on the detailed associations of specific maternal autoimmune diseases with a full spectrum of mental disorders in offspring, and more research on underlying mechanisms is needed as well,” she said.
 

Pay early attention

M. Susan Jay, MD, an adjunct professor of pediatrics at the Medical College of Wisconsin, Milwaukee, said previous efforts to examine the association between maternal autoimmunity were hampered by study design, small samples, and self-report of disease history – problems the new research avoids.

The large patient population allowed for detailed subgroup analysis of different conditions and outcomes. Another advantage was the availability of sociodemographic and clinical information, which allowed for the elimination of confounding factors, said Dr. Jay, who was not involved in the research.

“It would be prudent to follow children of mothers with autoimmune disorders before or during pregnancy for mental health issues, and if identified clinically, to offer psychological and developmental behavioral support options,” Dr. Jay added.

The authors have reported no relevant financial relationships.

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

Mental disorders were significantly more likely in children whose mothers had one of five common autoimmune diseases, a new study found.

Previous research has linked both maternal and paternal autoimmune diseases and specific mental disorders, such as attention-deficit/hyperactivity disorder (ADHD), but most of these studies focused on specific conditions in relatively small populations. The new study included data on more than 2 million births, making it one of the largest efforts to date to examine the association, according to the researchers, whose findings were published in JAMA Network Open.

Previous evidence of the possible association between certain maternal autoimmune diseases and mental disorders in offspring has been “scattered and limited,” which “hampered an overall understanding” of the link, Fei Li, MD, the corresponding author of the study, told this news organization.

Dr. Li, of Shanghai Jiao Tong University China, and colleagues reviewed data from a Danish registry cohort of singleton births with up to 38 years of follow-up. They explored associations between a range of maternal autoimmune diseases diagnosed before childbirth and the risks of mental disorders in children in early childhood through young adulthood.

The study population included 2,254,234 births and 38,916,359 person-years. Data on mental health were collected from the Psychiatric Central Research Register and the country’s National Patient Register. The median age of the children at the time of assessment was 16.7 years; approximately half were male.

A total of 50,863 children (2.26%) were born to mothers who had been diagnosed with autoimmune diseases before childbirth. During the follow-up period, 5,460 children of mothers with autoimmune diseases and 303,092 children of mothers without autoimmune diseases were diagnosed with a mental disorder (10.73% vs. 13.76%), according to the researchers.

The risk of being diagnosed with a mental disorder was significantly higher among children of mothers with any autoimmune disease (hazard ratio [HR,], 1.16), with an incidence of 9.38 vs. 7.91 per 1,000 person-years, the researchers reported.

The increased risk persisted when the results were classified by organ system, including connective tissue (HR, 1.11), endocrine (HR, 1.19), gastrointestinal (HR, 1.11), blood (HR, 1.10), nervous (HR, 1.17), and skin (HR, 1.19).

The five autoimmune diseases in mothers that were most commonly associated mental health disorders in children were type 1 diabetes, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and psoriasis vulgaris.

The greatest risk for children of mothers with any autoimmune disease was observed for organic conditions such as delirium, (HR, 1.54), followed by obsessive-compulsive disorder (HR, 1.42), schizophrenia (HR, 1.54), and mood problems (HR, 1.12).

Children of mothers with any autoimmune disorder also had a significantly increased risk of autism (HR, 1.21), intellectual disability (HR, 1.19), and ADHD (HR, 1.19).

The results add to evidence that activation of the maternal immune system may drive changes in the brain and behavioral problems, which has been observed in animal studies, the researchers wrote.

Potential underlying mechanisms in need of more exploration include genetic risk factors, maternal transmission of autoantibodies to the fetus during pregnancy, and the increased risk of obstetric complications, such as preterm birth, for women with autoimmune disorders that could affect mental development in children, they added.

The study findings were limited by several factors, including the lack of data on potential exacerbation of autoimmune disease activity during pregnancy and its effect on the fetus, the researchers noted. Other limitations included potential detection bias, lack of data on mental disorders in adulthood, and potential changes in diagnostic criteria over the long study period.

The results were strengthened by the use of a population-based registry, the large sample size, and ability to consider a range of confounders, the researchers said.

“This study could help acquire a comprehensive compilation of the associations between maternal autoimmune disorders diagnosed before childbirth and offspring’s mental disorders from childhood through early adulthood,” Dr. Li said in an interview.

For clinicians, Dr. Li said, the findings suggest that the offspring of mothers with autoimmune diseases may benefit from long-term surveillance for mental health disorders.

“Further studies should provide more evidence on the detailed associations of specific maternal autoimmune diseases with a full spectrum of mental disorders in offspring, and more research on underlying mechanisms is needed as well,” she said.
 

Pay early attention

M. Susan Jay, MD, an adjunct professor of pediatrics at the Medical College of Wisconsin, Milwaukee, said previous efforts to examine the association between maternal autoimmunity were hampered by study design, small samples, and self-report of disease history – problems the new research avoids.

The large patient population allowed for detailed subgroup analysis of different conditions and outcomes. Another advantage was the availability of sociodemographic and clinical information, which allowed for the elimination of confounding factors, said Dr. Jay, who was not involved in the research.

“It would be prudent to follow children of mothers with autoimmune disorders before or during pregnancy for mental health issues, and if identified clinically, to offer psychological and developmental behavioral support options,” Dr. Jay added.

The authors have reported no relevant financial relationships.

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

The U.S. Supreme Court may be on the cusp of overturning 50 years of American abortion law, according to a draft opinion in a Mississippi case that was leaked to the news outlet Politico.

The draft opinion, written by Justice Samuel Alito, outlines ways a presumed majority of the nine justices believes the 1973 ruling in Roe v. Wade was incorrect. If signed by a majority of the court, the ruling would eliminate the protections for abortion rights that Roe provided and give the 50 states the power to legislate abortion.

“We hold that Roe and Casey must be overruled,” Justice Alito writes in the draft. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

While a final ruling was not expected from the court until June, the leaked draft – a nearly unprecedented breach of the court’s internal workings – gives a strong signal of the court’s five most conservative members’ decisions. During oral arguments in the case in December, conservative justices appeared prepared to undo at least part of the country’s abortion protections.

President Joe Biden said his administration was already preparing for a potential ruling that struck down federal abortion protections.

The White House, he said in a statement, is working on a “response to the continued attack on abortion and reproductive rights, under a variety of possible outcomes in the cases pending before the Supreme Court. We will be ready when any ruling is issued.”

But if the draft opinion becomes final, he said the fight will move to the states.

“It will fall on our nation’s elected officials at all levels of government to protect a woman’s right to choose,” he said. “And it will fall on voters to elect pro-choice officials this November.”

With more pro-abortion rights members of Congress, it would be possible to pass federal legislation protecting abortion rights, “which I will work to pass and sign into law.”

Should the Alito draft become law, its first impact would be to allow a Mississippi law that bans abortions after 15 weeks to take effect.

But quickly after that, abortions would become illegal in many states. Several conservative-leaning states, mostly in the South and Midwest, have already passed laws severely restricting abortions well beyond what Roe allowed. Should Roe be overturned then, those laws would take effect without the threat of lengthy lawsuits or rulings from lower-court judges who have blocked them.

Nearly half of the states, mostly in the Northeast and West, would likely allow abortion to continue in some way. In fact, several states, including Colorado and Vermont, have already passed laws granting the right to an abortion into state law.

The leaked draft, however, is still a draft, meaning it remains possible Roe survives. Anthony Kreis, PhD, a professor of law at Georgia State University, says that could have been the point of whoever leaked the draft.

“It suggests to me that whoever leaked it knew that public outrage was the last resort to stopping the court from overturning Roe v. Wade and letting states ban all abortions,” Dr. Kreis said. “The danger that abortions won’t be legal in most of the country is very real.”

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

This article was updated 5/3/22.

The U.S. Supreme Court may be on the cusp of overturning 50 years of American abortion law, according to a draft opinion in a Mississippi case that was leaked to the news outlet Politico.

The draft opinion, written by Justice Samuel Alito, outlines ways a presumed majority of the nine justices believes the 1973 ruling in Roe v. Wade was incorrect. If signed by a majority of the court, the ruling would eliminate the protections for abortion rights that Roe provided and give the 50 states the power to legislate abortion.

“We hold that Roe and Casey must be overruled,” Justice Alito writes in the draft. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

While a final ruling was not expected from the court until June, the leaked draft – a nearly unprecedented breach of the court’s internal workings – gives a strong signal of the court’s five most conservative members’ decisions. During oral arguments in the case in December, conservative justices appeared prepared to undo at least part of the country’s abortion protections.

President Joe Biden said his administration was already preparing for a potential ruling that struck down federal abortion protections.

The White House, he said in a statement, is working on a “response to the continued attack on abortion and reproductive rights, under a variety of possible outcomes in the cases pending before the Supreme Court. We will be ready when any ruling is issued.”

But if the draft opinion becomes final, he said the fight will move to the states.

“It will fall on our nation’s elected officials at all levels of government to protect a woman’s right to choose,” he said. “And it will fall on voters to elect pro-choice officials this November.”

With more pro-abortion rights members of Congress, it would be possible to pass federal legislation protecting abortion rights, “which I will work to pass and sign into law.”

Should the Alito draft become law, its first impact would be to allow a Mississippi law that bans abortions after 15 weeks to take effect.

But quickly after that, abortions would become illegal in many states. Several conservative-leaning states, mostly in the South and Midwest, have already passed laws severely restricting abortions well beyond what Roe allowed. Should Roe be overturned then, those laws would take effect without the threat of lengthy lawsuits or rulings from lower-court judges who have blocked them.

Nearly half of the states, mostly in the Northeast and West, would likely allow abortion to continue in some way. In fact, several states, including Colorado and Vermont, have already passed laws granting the right to an abortion into state law.

The leaked draft, however, is still a draft, meaning it remains possible Roe survives. Anthony Kreis, PhD, a professor of law at Georgia State University, says that could have been the point of whoever leaked the draft.

“It suggests to me that whoever leaked it knew that public outrage was the last resort to stopping the court from overturning Roe v. Wade and letting states ban all abortions,” Dr. Kreis said. “The danger that abortions won’t be legal in most of the country is very real.”

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

This article was updated 5/3/22.

The U.S. Supreme Court may be on the cusp of overturning 50 years of American abortion law, according to a draft opinion in a Mississippi case that was leaked to the news outlet Politico.

The draft opinion, written by Justice Samuel Alito, outlines ways a presumed majority of the nine justices believes the 1973 ruling in Roe v. Wade was incorrect. If signed by a majority of the court, the ruling would eliminate the protections for abortion rights that Roe provided and give the 50 states the power to legislate abortion.

“We hold that Roe and Casey must be overruled,” Justice Alito writes in the draft. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

While a final ruling was not expected from the court until June, the leaked draft – a nearly unprecedented breach of the court’s internal workings – gives a strong signal of the court’s five most conservative members’ decisions. During oral arguments in the case in December, conservative justices appeared prepared to undo at least part of the country’s abortion protections.

President Joe Biden said his administration was already preparing for a potential ruling that struck down federal abortion protections.

The White House, he said in a statement, is working on a “response to the continued attack on abortion and reproductive rights, under a variety of possible outcomes in the cases pending before the Supreme Court. We will be ready when any ruling is issued.”

But if the draft opinion becomes final, he said the fight will move to the states.

“It will fall on our nation’s elected officials at all levels of government to protect a woman’s right to choose,” he said. “And it will fall on voters to elect pro-choice officials this November.”

With more pro-abortion rights members of Congress, it would be possible to pass federal legislation protecting abortion rights, “which I will work to pass and sign into law.”

Should the Alito draft become law, its first impact would be to allow a Mississippi law that bans abortions after 15 weeks to take effect.

But quickly after that, abortions would become illegal in many states. Several conservative-leaning states, mostly in the South and Midwest, have already passed laws severely restricting abortions well beyond what Roe allowed. Should Roe be overturned then, those laws would take effect without the threat of lengthy lawsuits or rulings from lower-court judges who have blocked them.

Nearly half of the states, mostly in the Northeast and West, would likely allow abortion to continue in some way. In fact, several states, including Colorado and Vermont, have already passed laws granting the right to an abortion into state law.

The leaked draft, however, is still a draft, meaning it remains possible Roe survives. Anthony Kreis, PhD, a professor of law at Georgia State University, says that could have been the point of whoever leaked the draft.

“It suggests to me that whoever leaked it knew that public outrage was the last resort to stopping the court from overturning Roe v. Wade and letting states ban all abortions,” Dr. Kreis said. “The danger that abortions won’t be legal in most of the country is very real.”

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

This article was updated 5/3/22.

A combination of ulipristal acetate (UA) and a cyclo-oxygenase-2 (COX-2) inhibitor holds promise as a pericoital, “on- demand” female oral contraceptive, taken only when needed, according to an exploratory study published in BMJ Sexual & Reproductive Health.

The prospective, open-label, pilot study showed that UA and meloxicam successfully disrupted ovulation at “the peak of luteal surge, when conception risk is highest,” reported lead author Erica P Cahill, MD, of Stanford (Calif.) University, and colleagues.

“There are many people who report being interested in preventing pregnancy who are not using contraception,” Dr. Cahill said in an interview. The ideal is to be able to take a medication to prevent ovulation and know that you wouldn’t ovulate or be able to become pregnant for the next 3-5 days. These would be pericoital contraceptive pills that one could take prior to or immediately after intercourse that would expand the contraceptive options available and meet some of this need, she said.

Dr. Cahill said currently approved emergency contraceptives containing ulipristal acetate or levonorgestrel “work by inhibiting ovulation at the level of the luteal surge, the pituitary signal that starts the ovulation cascade. Because of this mechanism, they are only effective when taken prior to that signal. If they are taken near or after ovulation has occurred, they are not effective.” She said combining meloxicam with UA could address this because meloxicam “has been shown to prevent some of the later steps of ovulation just prior to the egg being released.”

The study included nine healthy women, with a mean age of 31.4 years, and a mean body mass index of 24.5 ± 3.9 kg/m². All subjects had no exposure to hormonal medication, pregnancy, or lactation in the prior 3 months.

Each participant was followed for two cycles: The first without treatment, to establish normal ovulatory function; and the second during treatment with a one-time dose of UA 30 mg and meloxicam 30 mg during the “fertile window.” This window was defined as when the lead ovarian follicle had a mean diameter of 18 mm, and was determined via thrice-weekly ultrasounds, as well as luteinizing hormone (LH) measurements.

The primary outcome of the study was ovulation disruption, defined as unruptured dominant follicle for 5 days, a blunted LH peak, defined as <15 IU/L, and a nonovulatory luteal phase progesterone level, defined as <3 ng/mL.

Ovulation disruption was achieved in six subjects (67.7%), with eight subjects (88.9%) meeting some criteria.

“When we compare ovulation disruption rates in our study with the previous studies on which our protocol is based, the combination of UA and meloxicam disrupted ovulation at each phase of the fertile window more than any other medication previously studied,” the researchers wrote. “This medication combination is an important candidate to evaluate as oral pericoital contraception.”

When comparing subjects’ baseline cycles with their treatment cycles, the latter were approximately 3 days longer, although there was no difference in endometrial stripe thickness or irregular bleeding.

“Cycle length changes are an important parameter as people interested in oral, on-demand contraception may also be using fertility awareness methods which can be affected by cycle length changes.”

The authors noted that measures of full efficacy and side effects were beyond the scope of the study and would require repeat dosing. Similarly, liver enzymes were not measured, because there was only one dose of study medication, but “given the potential impact of repeat UA on liver enzymes, this measurement is critical for future studies.”

Asked to comment on the study, Eve Espey, MD, said that although it was limited in size and the use of an “intermediate outcome” of ovulation disruption, “the combination does show some promise as a focus of future research.” However, Dr. Espey, distinguished professor and chair in the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, said it is too early to determine the significance of the findings. “But it does point the way to further research,” she noted. “Compared with existing emergency contraception, this study shows that the UA-meloxicam combination disrupts ovulation over a broader mid-cycle time period – [an] extended duration of action [that] could theoretically translate into increased effectiveness as a contraceptive.”

The study was supported by the Society for Family Planning Research Fund. None of the authors, or Dr. Espey, declared competing interests.

A combination of ulipristal acetate (UA) and a cyclo-oxygenase-2 (COX-2) inhibitor holds promise as a pericoital, “on- demand” female oral contraceptive, taken only when needed, according to an exploratory study published in BMJ Sexual & Reproductive Health.

The prospective, open-label, pilot study showed that UA and meloxicam successfully disrupted ovulation at “the peak of luteal surge, when conception risk is highest,” reported lead author Erica P Cahill, MD, of Stanford (Calif.) University, and colleagues.

“There are many people who report being interested in preventing pregnancy who are not using contraception,” Dr. Cahill said in an interview. The ideal is to be able to take a medication to prevent ovulation and know that you wouldn’t ovulate or be able to become pregnant for the next 3-5 days. These would be pericoital contraceptive pills that one could take prior to or immediately after intercourse that would expand the contraceptive options available and meet some of this need, she said.

Dr. Cahill said currently approved emergency contraceptives containing ulipristal acetate or levonorgestrel “work by inhibiting ovulation at the level of the luteal surge, the pituitary signal that starts the ovulation cascade. Because of this mechanism, they are only effective when taken prior to that signal. If they are taken near or after ovulation has occurred, they are not effective.” She said combining meloxicam with UA could address this because meloxicam “has been shown to prevent some of the later steps of ovulation just prior to the egg being released.”

The study included nine healthy women, with a mean age of 31.4 years, and a mean body mass index of 24.5 ± 3.9 kg/m². All subjects had no exposure to hormonal medication, pregnancy, or lactation in the prior 3 months.

Each participant was followed for two cycles: The first without treatment, to establish normal ovulatory function; and the second during treatment with a one-time dose of UA 30 mg and meloxicam 30 mg during the “fertile window.” This window was defined as when the lead ovarian follicle had a mean diameter of 18 mm, and was determined via thrice-weekly ultrasounds, as well as luteinizing hormone (LH) measurements.

The primary outcome of the study was ovulation disruption, defined as unruptured dominant follicle for 5 days, a blunted LH peak, defined as <15 IU/L, and a nonovulatory luteal phase progesterone level, defined as <3 ng/mL.

Ovulation disruption was achieved in six subjects (67.7%), with eight subjects (88.9%) meeting some criteria.

“When we compare ovulation disruption rates in our study with the previous studies on which our protocol is based, the combination of UA and meloxicam disrupted ovulation at each phase of the fertile window more than any other medication previously studied,” the researchers wrote. “This medication combination is an important candidate to evaluate as oral pericoital contraception.”

When comparing subjects’ baseline cycles with their treatment cycles, the latter were approximately 3 days longer, although there was no difference in endometrial stripe thickness or irregular bleeding.

“Cycle length changes are an important parameter as people interested in oral, on-demand contraception may also be using fertility awareness methods which can be affected by cycle length changes.”

The authors noted that measures of full efficacy and side effects were beyond the scope of the study and would require repeat dosing. Similarly, liver enzymes were not measured, because there was only one dose of study medication, but “given the potential impact of repeat UA on liver enzymes, this measurement is critical for future studies.”

Asked to comment on the study, Eve Espey, MD, said that although it was limited in size and the use of an “intermediate outcome” of ovulation disruption, “the combination does show some promise as a focus of future research.” However, Dr. Espey, distinguished professor and chair in the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, said it is too early to determine the significance of the findings. “But it does point the way to further research,” she noted. “Compared with existing emergency contraception, this study shows that the UA-meloxicam combination disrupts ovulation over a broader mid-cycle time period – [an] extended duration of action [that] could theoretically translate into increased effectiveness as a contraceptive.”

The study was supported by the Society for Family Planning Research Fund. None of the authors, or Dr. Espey, declared competing interests.

A combination of ulipristal acetate (UA) and a cyclo-oxygenase-2 (COX-2) inhibitor holds promise as a pericoital, “on- demand” female oral contraceptive, taken only when needed, according to an exploratory study published in BMJ Sexual & Reproductive Health.

The prospective, open-label, pilot study showed that UA and meloxicam successfully disrupted ovulation at “the peak of luteal surge, when conception risk is highest,” reported lead author Erica P Cahill, MD, of Stanford (Calif.) University, and colleagues.

“There are many people who report being interested in preventing pregnancy who are not using contraception,” Dr. Cahill said in an interview. The ideal is to be able to take a medication to prevent ovulation and know that you wouldn’t ovulate or be able to become pregnant for the next 3-5 days. These would be pericoital contraceptive pills that one could take prior to or immediately after intercourse that would expand the contraceptive options available and meet some of this need, she said.

Dr. Cahill said currently approved emergency contraceptives containing ulipristal acetate or levonorgestrel “work by inhibiting ovulation at the level of the luteal surge, the pituitary signal that starts the ovulation cascade. Because of this mechanism, they are only effective when taken prior to that signal. If they are taken near or after ovulation has occurred, they are not effective.” She said combining meloxicam with UA could address this because meloxicam “has been shown to prevent some of the later steps of ovulation just prior to the egg being released.”

The study included nine healthy women, with a mean age of 31.4 years, and a mean body mass index of 24.5 ± 3.9 kg/m². All subjects had no exposure to hormonal medication, pregnancy, or lactation in the prior 3 months.

Each participant was followed for two cycles: The first without treatment, to establish normal ovulatory function; and the second during treatment with a one-time dose of UA 30 mg and meloxicam 30 mg during the “fertile window.” This window was defined as when the lead ovarian follicle had a mean diameter of 18 mm, and was determined via thrice-weekly ultrasounds, as well as luteinizing hormone (LH) measurements.

The primary outcome of the study was ovulation disruption, defined as unruptured dominant follicle for 5 days, a blunted LH peak, defined as <15 IU/L, and a nonovulatory luteal phase progesterone level, defined as <3 ng/mL.

Ovulation disruption was achieved in six subjects (67.7%), with eight subjects (88.9%) meeting some criteria.

“When we compare ovulation disruption rates in our study with the previous studies on which our protocol is based, the combination of UA and meloxicam disrupted ovulation at each phase of the fertile window more than any other medication previously studied,” the researchers wrote. “This medication combination is an important candidate to evaluate as oral pericoital contraception.”

When comparing subjects’ baseline cycles with their treatment cycles, the latter were approximately 3 days longer, although there was no difference in endometrial stripe thickness or irregular bleeding.

“Cycle length changes are an important parameter as people interested in oral, on-demand contraception may also be using fertility awareness methods which can be affected by cycle length changes.”

The authors noted that measures of full efficacy and side effects were beyond the scope of the study and would require repeat dosing. Similarly, liver enzymes were not measured, because there was only one dose of study medication, but “given the potential impact of repeat UA on liver enzymes, this measurement is critical for future studies.”

Asked to comment on the study, Eve Espey, MD, said that although it was limited in size and the use of an “intermediate outcome” of ovulation disruption, “the combination does show some promise as a focus of future research.” However, Dr. Espey, distinguished professor and chair in the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, said it is too early to determine the significance of the findings. “But it does point the way to further research,” she noted. “Compared with existing emergency contraception, this study shows that the UA-meloxicam combination disrupts ovulation over a broader mid-cycle time period – [an] extended duration of action [that] could theoretically translate into increased effectiveness as a contraceptive.”

The study was supported by the Society for Family Planning Research Fund. None of the authors, or Dr. Espey, declared competing interests.

The Food and Drug Administration has approved oteseconazole capsules (Vivjoa), an azole antifungal agent, for the prevention of recurrent yeast infections in women who are not of reproductive potential.

Oteseconazole inhibits CYP51, an enzyme fungi require to preserve the integrity of their cell walls and to grow properly, according to Mycovia, the drug’s manufacturer. It is the first FDA-approved product for the treatment of recurrent vulvovaginal candidiasis (RVVC).

Recurrent vulvovaginal candidiasis, or chronic yeast infection, affects an estimated 138 million women worldwide annually. The condition is defined as three or more symptomatic acute episodes of yeast infection within a 12-month period. The primary symptoms of RVVC include vaginal itching, burning, irritation, and inflammation. Some patients may also experience abnormal vaginal discharge and pain during sex or urination.

“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, chief development officer of Mycovia, said in a statement. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”

Approval for oteseconazole was based on results of three phase 3 trials involving 875 patients at 232 sites across 11 countries. In the U.S.-only ultraVIOLET trial, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and did not experience a recurrence during the 50-week maintenance period, compared with 57.1% of those who received fluconazole (Diflucan) followed by placebo (P < .001), according to Mycovia.

The most common side effects reported in phase 3 clinical studies were headache (7.4%) and nausea (3.6%), the company said. Patients with a hypersensitivity to oteseconazole should not take the drug, nor should those who are of reproductive potential, pregnant, or lactating.

Mycovia said it plans to launch the drug in the second quarter of 2022.

Full prescribing information is available online.

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

The Food and Drug Administration has approved oteseconazole capsules (Vivjoa), an azole antifungal agent, for the prevention of recurrent yeast infections in women who are not of reproductive potential.

Oteseconazole inhibits CYP51, an enzyme fungi require to preserve the integrity of their cell walls and to grow properly, according to Mycovia, the drug’s manufacturer. It is the first FDA-approved product for the treatment of recurrent vulvovaginal candidiasis (RVVC).

Recurrent vulvovaginal candidiasis, or chronic yeast infection, affects an estimated 138 million women worldwide annually. The condition is defined as three or more symptomatic acute episodes of yeast infection within a 12-month period. The primary symptoms of RVVC include vaginal itching, burning, irritation, and inflammation. Some patients may also experience abnormal vaginal discharge and pain during sex or urination.

“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, chief development officer of Mycovia, said in a statement. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”

Approval for oteseconazole was based on results of three phase 3 trials involving 875 patients at 232 sites across 11 countries. In the U.S.-only ultraVIOLET trial, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and did not experience a recurrence during the 50-week maintenance period, compared with 57.1% of those who received fluconazole (Diflucan) followed by placebo (P < .001), according to Mycovia.

The most common side effects reported in phase 3 clinical studies were headache (7.4%) and nausea (3.6%), the company said. Patients with a hypersensitivity to oteseconazole should not take the drug, nor should those who are of reproductive potential, pregnant, or lactating.

Mycovia said it plans to launch the drug in the second quarter of 2022.

Full prescribing information is available online.

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

The Food and Drug Administration has approved oteseconazole capsules (Vivjoa), an azole antifungal agent, for the prevention of recurrent yeast infections in women who are not of reproductive potential.

Oteseconazole inhibits CYP51, an enzyme fungi require to preserve the integrity of their cell walls and to grow properly, according to Mycovia, the drug’s manufacturer. It is the first FDA-approved product for the treatment of recurrent vulvovaginal candidiasis (RVVC).

Recurrent vulvovaginal candidiasis, or chronic yeast infection, affects an estimated 138 million women worldwide annually. The condition is defined as three or more symptomatic acute episodes of yeast infection within a 12-month period. The primary symptoms of RVVC include vaginal itching, burning, irritation, and inflammation. Some patients may also experience abnormal vaginal discharge and pain during sex or urination.

“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” Stephen Brand, PhD, chief development officer of Mycovia, said in a statement. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”

Approval for oteseconazole was based on results of three phase 3 trials involving 875 patients at 232 sites across 11 countries. In the U.S.-only ultraVIOLET trial, 89.7% of women with RVVC who received oteseconazole cleared their initial yeast infection and did not experience a recurrence during the 50-week maintenance period, compared with 57.1% of those who received fluconazole (Diflucan) followed by placebo (P < .001), according to Mycovia.

The most common side effects reported in phase 3 clinical studies were headache (7.4%) and nausea (3.6%), the company said. Patients with a hypersensitivity to oteseconazole should not take the drug, nor should those who are of reproductive potential, pregnant, or lactating.

Mycovia said it plans to launch the drug in the second quarter of 2022.

Full prescribing information is available online.

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

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

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

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

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

The prospect of having a premature infant can be highly stressful. But a new study found that providing pregnant patients hospitalized for preterm labor with detailed information about what to expect with an early birth significantly reduced their anxiety about the process.

The study found that both printed handouts and a tablet app were associated with a 50% reduction in anxiety and appeared to be equally effective, although the handouts are likely easier to use in the high-stress environment of neonatal intensive care facilities, according to the researchers, who presented the findings April 25 at the annual meeting of the Pediatric Academic Societies.

“When patients get admitted for preterm labor a neonatologist comes to talk to parents about outcomes, short- and long-term, like bleeding in the baby’s brain and the possible need to have surgeries,” said Nicole Rau, MD, assistant professor of clinical pediatrics at University of Illinois at Peoria, who led the study. “Then parents are asked to make decisions during a high-stress time while they’re still processing everything. Everyone agrees that’s really not ideal.”

About 1 in 10 babies in the United States are born prematurely – or before 37 weeks of gestation – each year. That adds up to about 500,000 per year. Many spend days or weeks in neonatal intensive care units – watched from a distance by their anxious parents desperate for answers and reassurance. Potential complications for infants born prematurely include heart issues, trouble breathing, brain bleeds, and difficulty controlling their body temperature.

The American Academy of Pediatrics and the National Institute of Child Health and Human Development have warned that birth parents at risk for premature delivery may not be adequately prepared for what to expect. According to the groups, although clinicians may counsel these patients on admission to the hospital, factors such as stress, pain, and maternal medication can make the message difficult to comprehend.

For the study, Dr. Rau and her colleagues divided patients at the Medical College of Wisconsin and Children’s Hospital of Wisconsin who were hospitalized between 22 and 33 weeks of pregnancy into two groups: Some received a handout on preterm labor, and some were given a bedside tablet with an app called Preemie Prep for Parents.

Seventy-six women were randomized in gestational age blocks of 22-24 weeks and 25-33 weeks. After some opted not to complete the study, 59 participants remained – 32 of whom received handouts, and 27 who had access to tablets.

After distributing the materials, Dr. Rau’s group gave patients a questionnaire asking about delivery resuscitation, short-term problems, long-term problems, treatments, length of stay, and miscellaneous questions about their care. The two groups performed similarly – the tablet group’s median score was 20/30, and the handout group’s median score was 22/30.

Using the State-Trait Anxiety Inventory, researchers found both groups experienced a 50% reduction in anxiety after learning more from their respective materials.

Dr. Rau said she and her colleagues expected patients with access to the app would perform better based on cognition studies that have shown multimedia tools are more effective than tools that use visual or audio information but not both. However, both groups seemed to benefit comparably, which she said may reflect underuse of the app.

What was clear, though, is that patients absorbed more information and felt better prepared when they received it in ways beyond verbal communication.

“Well-written, parent-friendly information is a great tool to supplement counseling,” Dr. Rau told this news organization.

Because preterm labor is a relatively common occurrence, expectant parents should be well-prepared with proper information, said Erika Werner, MD, chair of obstetrics & gynecology at Tufts Medical Center, Boston, who was not involved in the study.

“Preterm labor is something that’s way more common than people think,” Dr. Werner told this news organization. “As long as it’s coming from a trusted source, additional information is a good thing. Knowing in advance some of the things that might be different from what you expect is always important. The more that we as providers have time to educate patients about potential risks, the better the outcomes will be.”

The authors reported no relevant financial conflicts of interest. The study was supported by grants from Children’s Research Institute and AMAG Pharmaceuticals.

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

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

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

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

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

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

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

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

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