Women's Health

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.

Women opt for sterilization for a variety of reasons, but the goal is the same: to avoid getting pregnant.

But a head-to-head study of two forms of female sterilization has found surprisingly high rates of failure with the procedures.

The study compared the effectiveness of hysteroscopic sterilization, a nonincisional procedure, and minimally invasive laparoscopic sterilization. Although both methods prevented pregnancy in the vast majority of women, each was associated with more than a 6% failure rate 5 years after the procedure.

That figure is “much higher than expected,” said Aileen Gariepy, MD, MPH, the director of complex family planning at Weill Cornell Medicine, New York, who led the study.

The American College of Obstetricians and Gynecologists reported that the chance of pregnancy after sterilization is less than 1%, Dr. Gariepy said. “Women and pregnancy-capable people considering sterilization should be informed that, after the procedure, they have at least a 6% – not 1% – chance of pregnancy in the next 5 years.”

The study was published in Fertility and Sterility.

For laparoscopic sterilization, surgeons close or sever the fallopian tubes to prevent eggs from reaching the uterus and becoming fertilized.

Hysteroscopic sterilization involves the implantation of small, flexible metal coils into each fallopian tube, a process that produces inflammation and scarring that in turn prevents pregnancy. This method, called Essure and formerly marketed by Bayer, received approval by the Food and Drug Administration in 2002. But the agency received thousands of reports of adverse events with Essure, prompting regulators in 2016 to add a boxed warning to the product label about the risk for adverse events, including perforation, migration of the coils, allergic reactions, and pain.

Bayer pulled Essure from the market in 2019, citing decreased sales of the product. Some women did not have the device removed, however, and questions remain about its effectiveness, according to the researchers.

In the new study, Dr. Gariepy and colleagues examined Medicaid claims for 5906 hysteroscopic and 23,965 laparoscopic sterilizations performed in California between 2008 and 2014. They excluded sterilizations that were performed immediately after delivery, which involve a different approach.

The average age of the women in the study was 33 years.

The study found that, 5 years after the sterilization procedure, 6% of women in either group had become pregnant.

Despite the surprising new data, Chailee Moss, MD, an assistant professor of gynecology and obstetrics at Johns Hopkins University Medical Center, Baltimore, said she did not think the study would significantly affect the way she counsels her patients.

The main reason, she said, is that the study relied on an analysis of medical claims, which “is likely inferior to careful review of individual patient records or prospective collection of clinical data.” Home pregnancy tests may easily be excluded from such data and that patients can undergo ultrasound and termination procedures that would likely not be included in the data the researchers analyzed.

Dr. Moss added that the study was limited to California and that the researchers could not determine pregnancy rates for women who moved out of the state and thus received pregnancy care elsewhere. Nor did the authors account for the use of assistive reproductive technology, which can facilitate pregnancy after sterilization despite the success of the original procedure.

Dr. Gariepy, however, said the study may in fact have undercounted pregnancies and that the failure rates might be even higher than 6%, noting that California is “one of the largest, most populous and most diverse states” in terms of race, ethnicity, and other factors, making the new findings highly generalizable.

“I agree that study results should be confirmed by new nationwide study to determine risk of pregnancy after different sterilization methods,” she said. “Nevertheless, this retrospective cohort study delivers a strong signal that doctors and patients need to know about.”

Dr. Gariepy is on the board of directors of the Society of Family Planning. Dr. Moss has received research funding from Merck.

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

Women opt for sterilization for a variety of reasons, but the goal is the same: to avoid getting pregnant.

But a head-to-head study of two forms of female sterilization has found surprisingly high rates of failure with the procedures.

The study compared the effectiveness of hysteroscopic sterilization, a nonincisional procedure, and minimally invasive laparoscopic sterilization. Although both methods prevented pregnancy in the vast majority of women, each was associated with more than a 6% failure rate 5 years after the procedure.

That figure is “much higher than expected,” said Aileen Gariepy, MD, MPH, the director of complex family planning at Weill Cornell Medicine, New York, who led the study.

The American College of Obstetricians and Gynecologists reported that the chance of pregnancy after sterilization is less than 1%, Dr. Gariepy said. “Women and pregnancy-capable people considering sterilization should be informed that, after the procedure, they have at least a 6% – not 1% – chance of pregnancy in the next 5 years.”

The study was published in Fertility and Sterility.

For laparoscopic sterilization, surgeons close or sever the fallopian tubes to prevent eggs from reaching the uterus and becoming fertilized.

Hysteroscopic sterilization involves the implantation of small, flexible metal coils into each fallopian tube, a process that produces inflammation and scarring that in turn prevents pregnancy. This method, called Essure and formerly marketed by Bayer, received approval by the Food and Drug Administration in 2002. But the agency received thousands of reports of adverse events with Essure, prompting regulators in 2016 to add a boxed warning to the product label about the risk for adverse events, including perforation, migration of the coils, allergic reactions, and pain.

Bayer pulled Essure from the market in 2019, citing decreased sales of the product. Some women did not have the device removed, however, and questions remain about its effectiveness, according to the researchers.

In the new study, Dr. Gariepy and colleagues examined Medicaid claims for 5906 hysteroscopic and 23,965 laparoscopic sterilizations performed in California between 2008 and 2014. They excluded sterilizations that were performed immediately after delivery, which involve a different approach.

The average age of the women in the study was 33 years.

The study found that, 5 years after the sterilization procedure, 6% of women in either group had become pregnant.

Despite the surprising new data, Chailee Moss, MD, an assistant professor of gynecology and obstetrics at Johns Hopkins University Medical Center, Baltimore, said she did not think the study would significantly affect the way she counsels her patients.

The main reason, she said, is that the study relied on an analysis of medical claims, which “is likely inferior to careful review of individual patient records or prospective collection of clinical data.” Home pregnancy tests may easily be excluded from such data and that patients can undergo ultrasound and termination procedures that would likely not be included in the data the researchers analyzed.

Dr. Moss added that the study was limited to California and that the researchers could not determine pregnancy rates for women who moved out of the state and thus received pregnancy care elsewhere. Nor did the authors account for the use of assistive reproductive technology, which can facilitate pregnancy after sterilization despite the success of the original procedure.

Dr. Gariepy, however, said the study may in fact have undercounted pregnancies and that the failure rates might be even higher than 6%, noting that California is “one of the largest, most populous and most diverse states” in terms of race, ethnicity, and other factors, making the new findings highly generalizable.

“I agree that study results should be confirmed by new nationwide study to determine risk of pregnancy after different sterilization methods,” she said. “Nevertheless, this retrospective cohort study delivers a strong signal that doctors and patients need to know about.”

Dr. Gariepy is on the board of directors of the Society of Family Planning. Dr. Moss has received research funding from Merck.

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

Women opt for sterilization for a variety of reasons, but the goal is the same: to avoid getting pregnant.

But a head-to-head study of two forms of female sterilization has found surprisingly high rates of failure with the procedures.

The study compared the effectiveness of hysteroscopic sterilization, a nonincisional procedure, and minimally invasive laparoscopic sterilization. Although both methods prevented pregnancy in the vast majority of women, each was associated with more than a 6% failure rate 5 years after the procedure.

That figure is “much higher than expected,” said Aileen Gariepy, MD, MPH, the director of complex family planning at Weill Cornell Medicine, New York, who led the study.

The American College of Obstetricians and Gynecologists reported that the chance of pregnancy after sterilization is less than 1%, Dr. Gariepy said. “Women and pregnancy-capable people considering sterilization should be informed that, after the procedure, they have at least a 6% – not 1% – chance of pregnancy in the next 5 years.”

The study was published in Fertility and Sterility.

For laparoscopic sterilization, surgeons close or sever the fallopian tubes to prevent eggs from reaching the uterus and becoming fertilized.

Hysteroscopic sterilization involves the implantation of small, flexible metal coils into each fallopian tube, a process that produces inflammation and scarring that in turn prevents pregnancy. This method, called Essure and formerly marketed by Bayer, received approval by the Food and Drug Administration in 2002. But the agency received thousands of reports of adverse events with Essure, prompting regulators in 2016 to add a boxed warning to the product label about the risk for adverse events, including perforation, migration of the coils, allergic reactions, and pain.

Bayer pulled Essure from the market in 2019, citing decreased sales of the product. Some women did not have the device removed, however, and questions remain about its effectiveness, according to the researchers.

In the new study, Dr. Gariepy and colleagues examined Medicaid claims for 5906 hysteroscopic and 23,965 laparoscopic sterilizations performed in California between 2008 and 2014. They excluded sterilizations that were performed immediately after delivery, which involve a different approach.

The average age of the women in the study was 33 years.

The study found that, 5 years after the sterilization procedure, 6% of women in either group had become pregnant.

Despite the surprising new data, Chailee Moss, MD, an assistant professor of gynecology and obstetrics at Johns Hopkins University Medical Center, Baltimore, said she did not think the study would significantly affect the way she counsels her patients.

The main reason, she said, is that the study relied on an analysis of medical claims, which “is likely inferior to careful review of individual patient records or prospective collection of clinical data.” Home pregnancy tests may easily be excluded from such data and that patients can undergo ultrasound and termination procedures that would likely not be included in the data the researchers analyzed.

Dr. Moss added that the study was limited to California and that the researchers could not determine pregnancy rates for women who moved out of the state and thus received pregnancy care elsewhere. Nor did the authors account for the use of assistive reproductive technology, which can facilitate pregnancy after sterilization despite the success of the original procedure.

Dr. Gariepy, however, said the study may in fact have undercounted pregnancies and that the failure rates might be even higher than 6%, noting that California is “one of the largest, most populous and most diverse states” in terms of race, ethnicity, and other factors, making the new findings highly generalizable.

“I agree that study results should be confirmed by new nationwide study to determine risk of pregnancy after different sterilization methods,” she said. “Nevertheless, this retrospective cohort study delivers a strong signal that doctors and patients need to know about.”

Dr. Gariepy is on the board of directors of the Society of Family Planning. Dr. Moss has received research funding from Merck.

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

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial.

The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions, reported lead author Joan Camunas-Soler, PhD, of Mirvie, South San Francisco, and colleagues.

“Given the complex etiology of this heterogeneous syndrome, it would be advantageous to develop predictive tests that provide insight on the specific pathophysiology leading to preterm birth for each particular pregnancy,” Dr. Camunas-Soler and colleagues wrote in the American Journal of Obstetrics and Gynecology. “Such an approach could inform the development of preventive treatments and targeted therapeutics that are currently lacking/difficult to implement due to the heterogeneous etiology of sPTB.”

Currently, the best predictor of sPTB is previous sPTB, according to the investigators. Although a combination approach that incorporates cervical length and fetal fibronectin in cervicovaginal fluid is “of use,” they noted, “this is not standard of care in the U.S.A. nor recommended by the American College of Obstetricians and Gynecologists or the Society for Maternal-Fetal Medicine.” Existing molecular tests lack clinical data and may be inaccurate across diverse patient populations, they added.

The present study aimed to address these shortcomings by creating a second-trimester blood test for predicting sPTB. To identify relevant biomarkers, the investigators compared RNA profiles that were differentially expressed in three types of cases: term birth, early sPTB, and very early sPTB.

Among 242 women who contributed second-trimester blood samples for analysis, 194 went on to have a term birth. Of the remaining 48 women who gave birth spontaneously before 35 weeks’ gestation, 32 delivered between 25 and 35 weeks (early sPTB), while 16 delivered before 25 weeks’ gestation (very early sPTB). Slightly more than half of the patients were White, about one-third were Black, approximately 10% were Asian, and the remainder were of unknown race/ethnicity. Cases of preeclampsia were excluded.

The gene discovery and modeling process revealed 25 distinct genes that were significantly associated with early sPTB, offering a risk model with a sensitivity of 76% and a specificity of 72% (area under the curve, 0.80; 95% confidence interval, 0.72-0.87). Very early sPTB was associated with a set of 39 genes, giving a model with a sensitivity of 64% and a specificity of 80% (area under the curve = 0.76; 95% CI, 0.63-0.87).

Characterization of the two RNA profiles offered a glimpse into the underlying biological processes driving preterm birth. The genes predicting early sPTB are largely responsible for extracellular matrix degradation and remodeling, which could, “in terms of mechanism, reflect ongoing processes associated with cervical shortening, a feature often detected some weeks prior to sPTB,” the investigators wrote. In contrast, genes associated with very early sPTB are linked with insulinlike growth factor transport, which drives fetal growth and placentation. These findings could lead to development of pathway-specific interventions, Dr. Camunas-Soler and colleagues suggested.

According to coauthor Michal A. Elovitz, MD, the Hilarie L. Morgan and Mitchell L. Morgan President’s Distinguished Professor in Women’s Health at the University of Pennsylvania, Philadelphia, and chief medical advisor at Mirvie, the proprietary RNA platform moves beyond “unreliable and at times biased clinical factors such as race, BMI, and maternal age” to offer a “precision-based approach to pregnancy health.”

Excluding traditional risk factors also “promises more equitable care than the use of broad sociodemographic factors that often result in bias,” she added, noting that this may help address the higher rate of pregnancy complications among Black patients.

When asked about the potential for false-positive results, considering reported specificity rates of 72%-80%, Dr. Elovitz suggested that such concerns among pregnant women are an “unfortunate misconception.”

“It is not reflective of what women want regarding knowledge about the health of their pregnancy,” she said in a written comment. “Rather than be left in the dark, women want to be prepared for what is to come in their pregnancy journey.”

In support of this statement, Dr. Elovitz cited a recent study involving women with preeclampsia and other hypertensive disorders in pregnancy. A questionnaire showed that women appreciated pregnancy risk models when making decisions, and reported that they would have greater peace of mind if such tests were available.

*This story was updated on 4/26/2022. 

Pregnant women who had a higher adherence to a Mediterranean-style diet had a lower risk of preeclampsia, according to the results of a new study.

“As an observational study, it obviously has limitations that need to be considered, but these results build on other evidence that Mediterranean diet reduces cardiovascular risk and extends those findings to pregnancy as preeclampsia is a cardiovascular outcome,” senior author Noel T. Mueller, PhD, associate professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

The study was published online April 20 in the Journal of the American Heart Association.

The authors noted that preeclampsia, characterized by a range of symptoms including hypertension, proteinuria, and end-organ dysfunction, is a disorder that occurs in up to 5%-10% of all pregnant women worldwide, and is more common in Black women. It is a major cause of maternal and fetal morbidity and raises the risk for long-term cardiovascular disease (CVD), including chronic hypertension, coronary artery disease, ischemic stroke, and heart failure.

Children born to mothers with preeclampsia are at an elevated risk of having higher blood pressure and other abnormal cardiometabolic parameters.

The authors noted that multiple studies have demonstrated the benefit of the Mediterranean diet – characterized primarily by high intake of vegetables, fruits, and unsaturated fats – in reducing cardiovascular risk in the nonpregnant population. The current study was conducted to investigate whether benefits could also be seen in pregnant women in the form of a reduced risk of preeclampsia.

For the study, which used data from the Boston Birth Cohort, maternal sociodemographic and dietary data were obtained from 8,507 women via interview and food frequency questionnaire within 24-72 hours of giving birth. A Mediterranean-style diet score was calculated from the food frequency questionnaire. Additional clinical information, including physician diagnoses of preexisting conditions and preeclampsia, were extracted from medical records.

Of the women in the sample, 848 developed preeclampsia, of whom 47% were Black, and 28% were Hispanic.

After multivariable adjustment, the greatest adherence to a Mediterranean-style diet was associated with lower odds of developing preeclampsia (adjusted odds ratio comparing tertile 3 to tertile 1, 0.78; 95% confidence interval [CI], 0.64-0.96).

A subgroup analysis of Black women demonstrated a similar benefit with an adjusted odds ratio comparing tertile 3 to tertile 1 of 0.74 (95% CI, 0.76-0.96).

“In this racially and ethnically diverse cohort, women who had greater adherence to a Mediterranean-style diet during pregnancy had a greater than 20% lower odds of developing preeclampsia, after [adjustment] for potential confounders. In addition, the evidence for the protective effect of a Mediterranean-style diet against the odds of developing preeclampsia remained present in a subgroup analysis of Black women,” the researchers concluded.

Asked whether this would be enough evidence to recommend a Mediterranean diet to pregnant women, Dr. Mueller said that the organizations that issue dietary guidelines would probably require replication of these results and also possibly a randomized trial in a diverse population group before advocating such a diet.

“That is something we would like to do but this will take time and money,” he added.

Lead study author Anum Minhas, MD, Johns Hopkins University, Baltimore, said that in the meantime she would be recommending a Mediterranean diet to her pregnant patients. 

“The Mediterranean diet is a very healthy way of eating. I can’t see any downside of following such a diet in pregnancy, especially for high-risk women – those with obesity, hypertension or gestational diabetes, and there are likely other potential benefits such as reduced weight gain and reduced gestational diabetes,” she said.  

Dr. Mueller said he appreciated this pragmatic approach. “Sometimes there can be hesitation on making recommendations from observational studies, but the alternative to recommending this diet is either no recommendations on diet or recommending an alternative diet,” he said. “The Mediterranean diet or the DASH diet, which is quite similar, have shown by far the most evidence of cardioprotection of any diets. They have been shown to reduce blood pressure and lipids and improve cardiovascular risk, and I think we can now assume that that likely extends to pregnancy. I feel comfortable for this diet to be recommended to pregnant women.”

But he added: “Having said that, there is still a need for a randomized trial in pregnancy. We think it works but until we have a randomized trial we won’t know for sure, and we won’t know how much of a benefit we can get.”

Commenting on the study, JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, pointed out that this type of observational study is important for hypothesis generation but cannot prove cause and effect relationships.

“The evidence is promising enough,” said Dr. Manson, who was not involved with this study. But she added that to move forward, a randomized trial in women at elevated risk of preeclampsia would be needed, beginning in early pregnancy, if not earlier.

“In the meantime,” she noted, “several large-scale cohorts could be leveraged to look at diet assessed before or during pregnancy to see if this dietary pattern is prospectively related to lower risk of preeclampsia.

“With additional supportive data, and in view of the diet’s safety and general cardiovascular benefits, it could become a major tool for preventing adverse pregnancy outcomes.”

The Boston Birth Cohort study was supported in part by grants from the March of Dimes, the National Institutes of Health, and the Health Resources and Services Administration of the U.S. Department of Health and Human Services. The authors have disclosed no relevant financial relationships.

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

Pregnant women who had a higher adherence to a Mediterranean-style diet had a lower risk of preeclampsia, according to the results of a new study.

“As an observational study, it obviously has limitations that need to be considered, but these results build on other evidence that Mediterranean diet reduces cardiovascular risk and extends those findings to pregnancy as preeclampsia is a cardiovascular outcome,” senior author Noel T. Mueller, PhD, associate professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

The study was published online April 20 in the Journal of the American Heart Association.

The authors noted that preeclampsia, characterized by a range of symptoms including hypertension, proteinuria, and end-organ dysfunction, is a disorder that occurs in up to 5%-10% of all pregnant women worldwide, and is more common in Black women. It is a major cause of maternal and fetal morbidity and raises the risk for long-term cardiovascular disease (CVD), including chronic hypertension, coronary artery disease, ischemic stroke, and heart failure.

Children born to mothers with preeclampsia are at an elevated risk of having higher blood pressure and other abnormal cardiometabolic parameters.

The authors noted that multiple studies have demonstrated the benefit of the Mediterranean diet – characterized primarily by high intake of vegetables, fruits, and unsaturated fats – in reducing cardiovascular risk in the nonpregnant population. The current study was conducted to investigate whether benefits could also be seen in pregnant women in the form of a reduced risk of preeclampsia.

For the study, which used data from the Boston Birth Cohort, maternal sociodemographic and dietary data were obtained from 8,507 women via interview and food frequency questionnaire within 24-72 hours of giving birth. A Mediterranean-style diet score was calculated from the food frequency questionnaire. Additional clinical information, including physician diagnoses of preexisting conditions and preeclampsia, were extracted from medical records.

Of the women in the sample, 848 developed preeclampsia, of whom 47% were Black, and 28% were Hispanic.

After multivariable adjustment, the greatest adherence to a Mediterranean-style diet was associated with lower odds of developing preeclampsia (adjusted odds ratio comparing tertile 3 to tertile 1, 0.78; 95% confidence interval [CI], 0.64-0.96).

A subgroup analysis of Black women demonstrated a similar benefit with an adjusted odds ratio comparing tertile 3 to tertile 1 of 0.74 (95% CI, 0.76-0.96).

“In this racially and ethnically diverse cohort, women who had greater adherence to a Mediterranean-style diet during pregnancy had a greater than 20% lower odds of developing preeclampsia, after [adjustment] for potential confounders. In addition, the evidence for the protective effect of a Mediterranean-style diet against the odds of developing preeclampsia remained present in a subgroup analysis of Black women,” the researchers concluded.

Asked whether this would be enough evidence to recommend a Mediterranean diet to pregnant women, Dr. Mueller said that the organizations that issue dietary guidelines would probably require replication of these results and also possibly a randomized trial in a diverse population group before advocating such a diet.

“That is something we would like to do but this will take time and money,” he added.

Lead study author Anum Minhas, MD, Johns Hopkins University, Baltimore, said that in the meantime she would be recommending a Mediterranean diet to her pregnant patients. 

“The Mediterranean diet is a very healthy way of eating. I can’t see any downside of following such a diet in pregnancy, especially for high-risk women – those with obesity, hypertension or gestational diabetes, and there are likely other potential benefits such as reduced weight gain and reduced gestational diabetes,” she said.  

Dr. Mueller said he appreciated this pragmatic approach. “Sometimes there can be hesitation on making recommendations from observational studies, but the alternative to recommending this diet is either no recommendations on diet or recommending an alternative diet,” he said. “The Mediterranean diet or the DASH diet, which is quite similar, have shown by far the most evidence of cardioprotection of any diets. They have been shown to reduce blood pressure and lipids and improve cardiovascular risk, and I think we can now assume that that likely extends to pregnancy. I feel comfortable for this diet to be recommended to pregnant women.”

But he added: “Having said that, there is still a need for a randomized trial in pregnancy. We think it works but until we have a randomized trial we won’t know for sure, and we won’t know how much of a benefit we can get.”

Commenting on the study, JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, pointed out that this type of observational study is important for hypothesis generation but cannot prove cause and effect relationships.

“The evidence is promising enough,” said Dr. Manson, who was not involved with this study. But she added that to move forward, a randomized trial in women at elevated risk of preeclampsia would be needed, beginning in early pregnancy, if not earlier.

“In the meantime,” she noted, “several large-scale cohorts could be leveraged to look at diet assessed before or during pregnancy to see if this dietary pattern is prospectively related to lower risk of preeclampsia.

“With additional supportive data, and in view of the diet’s safety and general cardiovascular benefits, it could become a major tool for preventing adverse pregnancy outcomes.”

The Boston Birth Cohort study was supported in part by grants from the March of Dimes, the National Institutes of Health, and the Health Resources and Services Administration of the U.S. Department of Health and Human Services. The authors have disclosed no relevant financial relationships.

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

Pregnant women who had a higher adherence to a Mediterranean-style diet had a lower risk of preeclampsia, according to the results of a new study.

“As an observational study, it obviously has limitations that need to be considered, but these results build on other evidence that Mediterranean diet reduces cardiovascular risk and extends those findings to pregnancy as preeclampsia is a cardiovascular outcome,” senior author Noel T. Mueller, PhD, associate professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

The study was published online April 20 in the Journal of the American Heart Association.

The authors noted that preeclampsia, characterized by a range of symptoms including hypertension, proteinuria, and end-organ dysfunction, is a disorder that occurs in up to 5%-10% of all pregnant women worldwide, and is more common in Black women. It is a major cause of maternal and fetal morbidity and raises the risk for long-term cardiovascular disease (CVD), including chronic hypertension, coronary artery disease, ischemic stroke, and heart failure.

Children born to mothers with preeclampsia are at an elevated risk of having higher blood pressure and other abnormal cardiometabolic parameters.

The authors noted that multiple studies have demonstrated the benefit of the Mediterranean diet – characterized primarily by high intake of vegetables, fruits, and unsaturated fats – in reducing cardiovascular risk in the nonpregnant population. The current study was conducted to investigate whether benefits could also be seen in pregnant women in the form of a reduced risk of preeclampsia.

For the study, which used data from the Boston Birth Cohort, maternal sociodemographic and dietary data were obtained from 8,507 women via interview and food frequency questionnaire within 24-72 hours of giving birth. A Mediterranean-style diet score was calculated from the food frequency questionnaire. Additional clinical information, including physician diagnoses of preexisting conditions and preeclampsia, were extracted from medical records.

Of the women in the sample, 848 developed preeclampsia, of whom 47% were Black, and 28% were Hispanic.

After multivariable adjustment, the greatest adherence to a Mediterranean-style diet was associated with lower odds of developing preeclampsia (adjusted odds ratio comparing tertile 3 to tertile 1, 0.78; 95% confidence interval [CI], 0.64-0.96).

A subgroup analysis of Black women demonstrated a similar benefit with an adjusted odds ratio comparing tertile 3 to tertile 1 of 0.74 (95% CI, 0.76-0.96).

“In this racially and ethnically diverse cohort, women who had greater adherence to a Mediterranean-style diet during pregnancy had a greater than 20% lower odds of developing preeclampsia, after [adjustment] for potential confounders. In addition, the evidence for the protective effect of a Mediterranean-style diet against the odds of developing preeclampsia remained present in a subgroup analysis of Black women,” the researchers concluded.

Asked whether this would be enough evidence to recommend a Mediterranean diet to pregnant women, Dr. Mueller said that the organizations that issue dietary guidelines would probably require replication of these results and also possibly a randomized trial in a diverse population group before advocating such a diet.

“That is something we would like to do but this will take time and money,” he added.

Lead study author Anum Minhas, MD, Johns Hopkins University, Baltimore, said that in the meantime she would be recommending a Mediterranean diet to her pregnant patients. 

“The Mediterranean diet is a very healthy way of eating. I can’t see any downside of following such a diet in pregnancy, especially for high-risk women – those with obesity, hypertension or gestational diabetes, and there are likely other potential benefits such as reduced weight gain and reduced gestational diabetes,” she said.  

Dr. Mueller said he appreciated this pragmatic approach. “Sometimes there can be hesitation on making recommendations from observational studies, but the alternative to recommending this diet is either no recommendations on diet or recommending an alternative diet,” he said. “The Mediterranean diet or the DASH diet, which is quite similar, have shown by far the most evidence of cardioprotection of any diets. They have been shown to reduce blood pressure and lipids and improve cardiovascular risk, and I think we can now assume that that likely extends to pregnancy. I feel comfortable for this diet to be recommended to pregnant women.”

But he added: “Having said that, there is still a need for a randomized trial in pregnancy. We think it works but until we have a randomized trial we won’t know for sure, and we won’t know how much of a benefit we can get.”

Commenting on the study, JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, pointed out that this type of observational study is important for hypothesis generation but cannot prove cause and effect relationships.

“The evidence is promising enough,” said Dr. Manson, who was not involved with this study. But she added that to move forward, a randomized trial in women at elevated risk of preeclampsia would be needed, beginning in early pregnancy, if not earlier.

“In the meantime,” she noted, “several large-scale cohorts could be leveraged to look at diet assessed before or during pregnancy to see if this dietary pattern is prospectively related to lower risk of preeclampsia.

“With additional supportive data, and in view of the diet’s safety and general cardiovascular benefits, it could become a major tool for preventing adverse pregnancy outcomes.”

The Boston Birth Cohort study was supported in part by grants from the March of Dimes, the National Institutes of Health, and the Health Resources and Services Administration of the U.S. Department of Health and Human Services. The authors have disclosed no relevant financial relationships.

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