Women's Health

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.

In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.

This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.

Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.

“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.

Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.

The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.

The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).

Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
 

Some dual protection suggested

Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.

“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.

Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.

The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls. 

Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.

Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.

Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.

A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
 

Maternal vaccination trends

A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.

“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Engaging with a “chatbot,” a computer program that simulates human conversation, helps prevent eating disorders (EDs) in at-risk individuals, new research suggests.

Results of a randomized trial show that at-risk women who interacted with the chatbot showed lower concern about their weight and body shape compared to a wait-list control group.

“Chatbots are widely used in industry and have begun to be used in medical settings, although few studies have examined their effectiveness for mental health issues and none address EDs or ED prevention,” senior investigator C. Barr Taylor, MD, a research faculty member at Palo Alto (Calif.) University, said in a press release.

“We found that the group with access to the chatbot had a greater reduction in weight and shape concerns, both right after using it at 3 months and at the 6-month follow-up. The effects had sustainability over time, and we also found indication that the chatbot may reduce ED onset more so than the control group, where there was a greater incidence of EDs,” Dr. Taylor told this news organization.

The study was published online Dec. 28, 2021, in the International Journal of Eating Disorders.
 

Deadly disorders

“EDs are a common problem with huge risk factors; and, given how widespread they are, we need scalable tools that can reach a lot of people at low cost, reduce risk factors for developing an ED – which is the second most deadly of all psychiatric illnesses – so prevention is of the utmost importance,” Dr. Taylor said.

The investigators developed a targeted Internet-based preventive program called StudentBodies that utilizes cognitive-behavioral therapy approaches. The program was successful in reducing weight/shape concerns in women at high risk for the onset of an ED, and it reduced ED onset in the highest-risk women.

However, it required trained moderators who spent over 45 minutes with participants. Given the large number of people at risk for an ED who might benefit, the researchers noted that it is unlikely that a human-moderated version would be widely disseminated.

A chatbot may represent a “possible solution to reducing delivery costs” because it mimics aspects of human moderation in simulating conversations, the investigators noted.

“We wanted to take the earlier program we developed into this century and program it for delivery in this new format that would allow for bite-size pieces of information for the chatbot to communicate to the user,” lead author Ellen Fitzsimmons-Craft, PhD, assistant professor of psychiatry, Washington University, St. Louis, told this news organization.

“Our ED prevention online version was more effective when there was guidance from a human moderator who could provide feedback on progress, encourage you to go on, and apply the skills in daily life. But that’s not the most scalable. So we thought that a chatbot, in addition to providing content in this perhaps more engaging format, could also provide some aspect of human moderation, although the person is chatting with a robot,” added Dr. Fitzsimmons-Craft, associate director of the Center for Healthy Weight and Wellness.
 

Tessa will speak to you now

Participants (n = 700 women; mean [SD] age, 21.08 [3.09] years; 84.6% White; 53.8% heterosexual; 31.08% bisexual), were randomized to an intervention group or a wait-list control group (n = 352 and 348, respectively). There were no significant differences between groups in age, race, ethnicity, education, or sexual orientation.

The StudentBodies program was adapted for delivery via a chatbot named Tessa “while retaining the core intervention principles” and referred to as “Body Positive.”

It consisted of several components programmed into the chatbot, which initiated each conversation in a predetermined order. Participants were encouraged to engage in two conversations weekly. The program included an introduction and eight sessions as well as a crisis module that provided users with a referral to a crisis hotline in case of emergency. Referral was triggered on the basis of “recognized keywords,” such as “hurting myself.”

The researchers used the Weight Concerns Scale questionnaire to assess weight and shape concerns and the Internalization: Thin/Low Body Fat subscale of the Sociocultural Attitudes Toward Appearance Questionnaire–4 to “assess the cognitive aspect of thin-ideal internalization.”

Secondary outcomes tested the hypothesis that the chatbot would be more likely to reduce clinical outcomes (ED psychopathology, depression, and anxiety) and prevent ED onset, compared to the control condition.
 

Ready for prime time

At 3- and 6-month follow-up, there was significantly greater reduction in the intervention group compared with the control group in weight/shape concerns (d = -.20, P = .03 and d = -.19, P = .04, respectively), although there were no differences in thin-ideal internalization change.

The chatbot intervention was associated with significantly greater reductions in overall ED psychopathology at 3 months (d = -.29, P = .003) compared to the control condition, but not at 6 months.

Notably, the intervention group had significantly higher odds than the control group of remaining nonclinical for EDs at 3- and 6-month follow-up (OR, 2.37 [95% confidence interval, 1.37-4.11] and OR, 2.13 [95% CI,1.26-3.59], respectively).

“We were very excited about the study, and frankly, I was surprised by the effectiveness [of the chatbot intervention] because I didn’t think it would have as much of an impact as it did,” said Dr. Taylor. “Prevention gets short shrift everywhere, and I think we succeeded very well.”

Dr. Fitzsimmons-Craft added that the National Eating Disorders Association (NEDA) has agreed to make the chatbot available on its website for people who screen positive for having an ED or for being at high risk, and so their group is working with their industry partner, a company called X2AI, which developed the chatbot, to make this happen.

“This is definitely the fastest research-to-practice translation I’ve ever seen, where we can so quickly show that it works and make it available to tens of thousands almost immediately.”

Dr. Fitzsimmons-Craft is optimistic that it will be available to launch the week of Feb. 21, which is National Eating Disorders Week.
 

Innovative, creative research

Commenting on the research, Evelyn Attia, MD, professor of psychiatry, Columbia University Medical Center, and director of the Columbia Center for Eating Disorders New York–Presbyterian Hospital, New York, described the study as “innovative and creative.”

New York-Presbyterian Hospital

Dr. Attia, a member of the Research Advisory Council of the NEDA, noted that the structure of the study is “very preliminary” and that the comparison to a wait-list control makes it hard to know whether this is an effective intervention compared with other types of interventions, rather than compared with no intervention.

“But I’m sure that when the researchers are set up and primed to study this more robustly, they will consider a more active control intervention to see whether this preliminary finding holds up,” she said.

Also commenting on the study, Deborah R. Glasofer, PhD, associate professor of clinical medical psychology (in psychiatry), Columbia Center for Eating Disorders, said, “Higher-than-average concern about appearance – body shape, size, or weight – and a tightly held belief that it is ideal to be thin are known risk factors for the development of an eating disorder.

“This study offers an indication that technology can be leveraged to fill a gap and help folks before unhelpful and sometimes misguided thoughts about food, eating, and appearance evolve into a full-blown eating disorder,” said Dr. Glasofer, who was not involved with the study.

The study was supported by the NEDA Feeding Hope Fund, the National Institute of Mental Health, the National Heart, Lung, and Blood Institute, and the Swedish Research Council. The authors and Dr. Glasofer have disclosed no relevant financial relationships. Dr. Attia is on the board and the Research Advisory Council of NEDA.

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

Engaging with a “chatbot,” a computer program that simulates human conversation, helps prevent eating disorders (EDs) in at-risk individuals, new research suggests.

Results of a randomized trial show that at-risk women who interacted with the chatbot showed lower concern about their weight and body shape compared to a wait-list control group.

“Chatbots are widely used in industry and have begun to be used in medical settings, although few studies have examined their effectiveness for mental health issues and none address EDs or ED prevention,” senior investigator C. Barr Taylor, MD, a research faculty member at Palo Alto (Calif.) University, said in a press release.

“We found that the group with access to the chatbot had a greater reduction in weight and shape concerns, both right after using it at 3 months and at the 6-month follow-up. The effects had sustainability over time, and we also found indication that the chatbot may reduce ED onset more so than the control group, where there was a greater incidence of EDs,” Dr. Taylor told this news organization.

The study was published online Dec. 28, 2021, in the International Journal of Eating Disorders.
 

Deadly disorders

“EDs are a common problem with huge risk factors; and, given how widespread they are, we need scalable tools that can reach a lot of people at low cost, reduce risk factors for developing an ED – which is the second most deadly of all psychiatric illnesses – so prevention is of the utmost importance,” Dr. Taylor said.

The investigators developed a targeted Internet-based preventive program called StudentBodies that utilizes cognitive-behavioral therapy approaches. The program was successful in reducing weight/shape concerns in women at high risk for the onset of an ED, and it reduced ED onset in the highest-risk women.

However, it required trained moderators who spent over 45 minutes with participants. Given the large number of people at risk for an ED who might benefit, the researchers noted that it is unlikely that a human-moderated version would be widely disseminated.

A chatbot may represent a “possible solution to reducing delivery costs” because it mimics aspects of human moderation in simulating conversations, the investigators noted.

“We wanted to take the earlier program we developed into this century and program it for delivery in this new format that would allow for bite-size pieces of information for the chatbot to communicate to the user,” lead author Ellen Fitzsimmons-Craft, PhD, assistant professor of psychiatry, Washington University, St. Louis, told this news organization.

“Our ED prevention online version was more effective when there was guidance from a human moderator who could provide feedback on progress, encourage you to go on, and apply the skills in daily life. But that’s not the most scalable. So we thought that a chatbot, in addition to providing content in this perhaps more engaging format, could also provide some aspect of human moderation, although the person is chatting with a robot,” added Dr. Fitzsimmons-Craft, associate director of the Center for Healthy Weight and Wellness.
 

Tessa will speak to you now

Participants (n = 700 women; mean [SD] age, 21.08 [3.09] years; 84.6% White; 53.8% heterosexual; 31.08% bisexual), were randomized to an intervention group or a wait-list control group (n = 352 and 348, respectively). There were no significant differences between groups in age, race, ethnicity, education, or sexual orientation.

The StudentBodies program was adapted for delivery via a chatbot named Tessa “while retaining the core intervention principles” and referred to as “Body Positive.”

It consisted of several components programmed into the chatbot, which initiated each conversation in a predetermined order. Participants were encouraged to engage in two conversations weekly. The program included an introduction and eight sessions as well as a crisis module that provided users with a referral to a crisis hotline in case of emergency. Referral was triggered on the basis of “recognized keywords,” such as “hurting myself.”

The researchers used the Weight Concerns Scale questionnaire to assess weight and shape concerns and the Internalization: Thin/Low Body Fat subscale of the Sociocultural Attitudes Toward Appearance Questionnaire–4 to “assess the cognitive aspect of thin-ideal internalization.”

Secondary outcomes tested the hypothesis that the chatbot would be more likely to reduce clinical outcomes (ED psychopathology, depression, and anxiety) and prevent ED onset, compared to the control condition.
 

Ready for prime time

At 3- and 6-month follow-up, there was significantly greater reduction in the intervention group compared with the control group in weight/shape concerns (d = -.20, P = .03 and d = -.19, P = .04, respectively), although there were no differences in thin-ideal internalization change.

The chatbot intervention was associated with significantly greater reductions in overall ED psychopathology at 3 months (d = -.29, P = .003) compared to the control condition, but not at 6 months.

Notably, the intervention group had significantly higher odds than the control group of remaining nonclinical for EDs at 3- and 6-month follow-up (OR, 2.37 [95% confidence interval, 1.37-4.11] and OR, 2.13 [95% CI,1.26-3.59], respectively).

“We were very excited about the study, and frankly, I was surprised by the effectiveness [of the chatbot intervention] because I didn’t think it would have as much of an impact as it did,” said Dr. Taylor. “Prevention gets short shrift everywhere, and I think we succeeded very well.”

Dr. Fitzsimmons-Craft added that the National Eating Disorders Association (NEDA) has agreed to make the chatbot available on its website for people who screen positive for having an ED or for being at high risk, and so their group is working with their industry partner, a company called X2AI, which developed the chatbot, to make this happen.

“This is definitely the fastest research-to-practice translation I’ve ever seen, where we can so quickly show that it works and make it available to tens of thousands almost immediately.”

Dr. Fitzsimmons-Craft is optimistic that it will be available to launch the week of Feb. 21, which is National Eating Disorders Week.
 

Innovative, creative research

Commenting on the research, Evelyn Attia, MD, professor of psychiatry, Columbia University Medical Center, and director of the Columbia Center for Eating Disorders New York–Presbyterian Hospital, New York, described the study as “innovative and creative.”

New York-Presbyterian Hospital

Dr. Attia, a member of the Research Advisory Council of the NEDA, noted that the structure of the study is “very preliminary” and that the comparison to a wait-list control makes it hard to know whether this is an effective intervention compared with other types of interventions, rather than compared with no intervention.

“But I’m sure that when the researchers are set up and primed to study this more robustly, they will consider a more active control intervention to see whether this preliminary finding holds up,” she said.

Also commenting on the study, Deborah R. Glasofer, PhD, associate professor of clinical medical psychology (in psychiatry), Columbia Center for Eating Disorders, said, “Higher-than-average concern about appearance – body shape, size, or weight – and a tightly held belief that it is ideal to be thin are known risk factors for the development of an eating disorder.

“This study offers an indication that technology can be leveraged to fill a gap and help folks before unhelpful and sometimes misguided thoughts about food, eating, and appearance evolve into a full-blown eating disorder,” said Dr. Glasofer, who was not involved with the study.

The study was supported by the NEDA Feeding Hope Fund, the National Institute of Mental Health, the National Heart, Lung, and Blood Institute, and the Swedish Research Council. The authors and Dr. Glasofer have disclosed no relevant financial relationships. Dr. Attia is on the board and the Research Advisory Council of NEDA.

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

Engaging with a “chatbot,” a computer program that simulates human conversation, helps prevent eating disorders (EDs) in at-risk individuals, new research suggests.

Results of a randomized trial show that at-risk women who interacted with the chatbot showed lower concern about their weight and body shape compared to a wait-list control group.

“Chatbots are widely used in industry and have begun to be used in medical settings, although few studies have examined their effectiveness for mental health issues and none address EDs or ED prevention,” senior investigator C. Barr Taylor, MD, a research faculty member at Palo Alto (Calif.) University, said in a press release.

“We found that the group with access to the chatbot had a greater reduction in weight and shape concerns, both right after using it at 3 months and at the 6-month follow-up. The effects had sustainability over time, and we also found indication that the chatbot may reduce ED onset more so than the control group, where there was a greater incidence of EDs,” Dr. Taylor told this news organization.

The study was published online Dec. 28, 2021, in the International Journal of Eating Disorders.
 

Deadly disorders

“EDs are a common problem with huge risk factors; and, given how widespread they are, we need scalable tools that can reach a lot of people at low cost, reduce risk factors for developing an ED – which is the second most deadly of all psychiatric illnesses – so prevention is of the utmost importance,” Dr. Taylor said.

The investigators developed a targeted Internet-based preventive program called StudentBodies that utilizes cognitive-behavioral therapy approaches. The program was successful in reducing weight/shape concerns in women at high risk for the onset of an ED, and it reduced ED onset in the highest-risk women.

However, it required trained moderators who spent over 45 minutes with participants. Given the large number of people at risk for an ED who might benefit, the researchers noted that it is unlikely that a human-moderated version would be widely disseminated.

A chatbot may represent a “possible solution to reducing delivery costs” because it mimics aspects of human moderation in simulating conversations, the investigators noted.

“We wanted to take the earlier program we developed into this century and program it for delivery in this new format that would allow for bite-size pieces of information for the chatbot to communicate to the user,” lead author Ellen Fitzsimmons-Craft, PhD, assistant professor of psychiatry, Washington University, St. Louis, told this news organization.

“Our ED prevention online version was more effective when there was guidance from a human moderator who could provide feedback on progress, encourage you to go on, and apply the skills in daily life. But that’s not the most scalable. So we thought that a chatbot, in addition to providing content in this perhaps more engaging format, could also provide some aspect of human moderation, although the person is chatting with a robot,” added Dr. Fitzsimmons-Craft, associate director of the Center for Healthy Weight and Wellness.
 

Tessa will speak to you now

Participants (n = 700 women; mean [SD] age, 21.08 [3.09] years; 84.6% White; 53.8% heterosexual; 31.08% bisexual), were randomized to an intervention group or a wait-list control group (n = 352 and 348, respectively). There were no significant differences between groups in age, race, ethnicity, education, or sexual orientation.

The StudentBodies program was adapted for delivery via a chatbot named Tessa “while retaining the core intervention principles” and referred to as “Body Positive.”

It consisted of several components programmed into the chatbot, which initiated each conversation in a predetermined order. Participants were encouraged to engage in two conversations weekly. The program included an introduction and eight sessions as well as a crisis module that provided users with a referral to a crisis hotline in case of emergency. Referral was triggered on the basis of “recognized keywords,” such as “hurting myself.”

The researchers used the Weight Concerns Scale questionnaire to assess weight and shape concerns and the Internalization: Thin/Low Body Fat subscale of the Sociocultural Attitudes Toward Appearance Questionnaire–4 to “assess the cognitive aspect of thin-ideal internalization.”

Secondary outcomes tested the hypothesis that the chatbot would be more likely to reduce clinical outcomes (ED psychopathology, depression, and anxiety) and prevent ED onset, compared to the control condition.
 

Ready for prime time

At 3- and 6-month follow-up, there was significantly greater reduction in the intervention group compared with the control group in weight/shape concerns (d = -.20, P = .03 and d = -.19, P = .04, respectively), although there were no differences in thin-ideal internalization change.

The chatbot intervention was associated with significantly greater reductions in overall ED psychopathology at 3 months (d = -.29, P = .003) compared to the control condition, but not at 6 months.

Notably, the intervention group had significantly higher odds than the control group of remaining nonclinical for EDs at 3- and 6-month follow-up (OR, 2.37 [95% confidence interval, 1.37-4.11] and OR, 2.13 [95% CI,1.26-3.59], respectively).

“We were very excited about the study, and frankly, I was surprised by the effectiveness [of the chatbot intervention] because I didn’t think it would have as much of an impact as it did,” said Dr. Taylor. “Prevention gets short shrift everywhere, and I think we succeeded very well.”

Dr. Fitzsimmons-Craft added that the National Eating Disorders Association (NEDA) has agreed to make the chatbot available on its website for people who screen positive for having an ED or for being at high risk, and so their group is working with their industry partner, a company called X2AI, which developed the chatbot, to make this happen.

“This is definitely the fastest research-to-practice translation I’ve ever seen, where we can so quickly show that it works and make it available to tens of thousands almost immediately.”

Dr. Fitzsimmons-Craft is optimistic that it will be available to launch the week of Feb. 21, which is National Eating Disorders Week.
 

Innovative, creative research

Commenting on the research, Evelyn Attia, MD, professor of psychiatry, Columbia University Medical Center, and director of the Columbia Center for Eating Disorders New York–Presbyterian Hospital, New York, described the study as “innovative and creative.”

New York-Presbyterian Hospital

Dr. Attia, a member of the Research Advisory Council of the NEDA, noted that the structure of the study is “very preliminary” and that the comparison to a wait-list control makes it hard to know whether this is an effective intervention compared with other types of interventions, rather than compared with no intervention.

“But I’m sure that when the researchers are set up and primed to study this more robustly, they will consider a more active control intervention to see whether this preliminary finding holds up,” she said.

Also commenting on the study, Deborah R. Glasofer, PhD, associate professor of clinical medical psychology (in psychiatry), Columbia Center for Eating Disorders, said, “Higher-than-average concern about appearance – body shape, size, or weight – and a tightly held belief that it is ideal to be thin are known risk factors for the development of an eating disorder.

“This study offers an indication that technology can be leveraged to fill a gap and help folks before unhelpful and sometimes misguided thoughts about food, eating, and appearance evolve into a full-blown eating disorder,” said Dr. Glasofer, who was not involved with the study.

The study was supported by the NEDA Feeding Hope Fund, the National Institute of Mental Health, the National Heart, Lung, and Blood Institute, and the Swedish Research Council. The authors and Dr. Glasofer have disclosed no relevant financial relationships. Dr. Attia is on the board and the Research Advisory Council of NEDA.

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

Polycystic ovary syndrome is common in girls with type 2 diabetes, findings of a new study suggest, and authors say screening for PCOS is critical in this group.

In a systematic review and meta-analysis involving 470 girls (average age 12.9-16.1 years) with type 2 diabetes in six studies, the prevalence of PCOS was nearly 1 in 5 (19.58%; 95% confidence interval, 12.02%-27.14%; P = .002), substantially higher than that of PCOS in the general adolescent population.

PCOS, a complex endocrine disorder, occurs in 1.14%-11.04% of adolescent girls globally, according to the paper published online in JAMA Network Open.

The secondary outcome studied links to prevalence of PCOS with race and obesity.

Insulin resistance and compensatory hyperinsulinemia are present in 44%-70% of women with PCOS, suggesting that they are more likely to develop type 2 diabetes, according to the researchers led by Milena Cioana, BHSc, with the department of pediatrics, McMaster University, Hamilton, Ont.

Kelly A. Curran, MD, an assistant professor of pediatrics at the University of Oklahoma Health Sciences Center in Oklahoma City, where she practices adolescent medicine, said in an interview that it has been known that women with PCOS have higher rates of diabetes and many in the field have suspected the relationship is bidirectional.

“In my clinical practice, I’ve seen a high percentage of women with type 2 diabetes present with irregular menses, some of whom have gone on to be diagnosed with PCOS,” said Dr. Curran, who was not involved with the study.

However, she said, she was surprised the prevalence of PCOS reported in this paper – nearly one in five – was so high. Early diagnosis is important for PCOS to prevent complications such as hypertension, hyperglycemia, and dyslipidemia.

Psychiatric conditions are also prevalent in patients with PCOS, including anxiety (18%), depression (16%), and ADHD (9%).

Dr. Curran agreed there is a need to screen for PCOS and to evaluate for other causes of irregular periods in patients with type 2 diabetes.

“Menstrual irregularities are often overlooked in young women without further work-up, especially in patients who have chronic illnesses,” she noted.
 

Results come with a caveat

However, the authors said, results should be viewed with caution because “studies including the larger numbers of girls did not report the criteria used to diagnose PCOS, which is a challenge during adolescence.”

Diagnostic criteria for PCOS during adolescence include the combination of menstrual irregularities according to time since their first period and clinical or biochemical hyperandrogenism after excluding other potential causes.

Dr. Curran explained that PCOS symptoms include irregular periods and acne which can overlap with normal changes in puberty. In her experience, PCOS is often diagnosed without patients meeting full criteria. She agreed further research with standardized criteria is urgently needed.

The European Society of Human Reproduction and Embryology/American Society of Reproductive Medicine, the Pediatric Endocrine Society, and the International Consortium of Paediatric Endocrinology guidelines suggest that using ultrasound to check the size of ovaries could help diagnose PCOS, but other guidelines are more conservative, the authors noted.

They added that “there is a need for a consensus to establish the pediatric criteria for diagnosing PCOS in adolescents to ensure accurate diagnosis and lower the misclassification rates.”
 

Assessing links to obesity and race

Still unclear, the authors wrote, is whether and how obesity and race affect prevalence of PCOS among girls with type 2 diabetes.

The authors wrote: “Although earlier studies suggested that obesity-related insulin resistance and hyperinsulinemia can contribute to PCOS pathogenesis, insulin resistance in patients with PCOS may be present independently of [body mass index]. Obesity seems to increase the risk of PCOS only slightly and might represent a referral bias for PCOS.”

Few studies included in the meta-analysis had race-specific data, so the authors were limited in assessing associations between race and PCOS prevalence.

“However,” they wrote, “our data demonstrate that Indian girls had the highest prevalence, followed by White girls, and then Indigenous girls in Canada.”

Further studies are needed to help define at-risk subgroups and evaluate treatment strategies, the authors noted.

They reported having no relevant financial relationships. Dr. Curran had no conflicts of interest.

Polycystic ovary syndrome is common in girls with type 2 diabetes, findings of a new study suggest, and authors say screening for PCOS is critical in this group.

In a systematic review and meta-analysis involving 470 girls (average age 12.9-16.1 years) with type 2 diabetes in six studies, the prevalence of PCOS was nearly 1 in 5 (19.58%; 95% confidence interval, 12.02%-27.14%; P = .002), substantially higher than that of PCOS in the general adolescent population.

PCOS, a complex endocrine disorder, occurs in 1.14%-11.04% of adolescent girls globally, according to the paper published online in JAMA Network Open.

The secondary outcome studied links to prevalence of PCOS with race and obesity.

Insulin resistance and compensatory hyperinsulinemia are present in 44%-70% of women with PCOS, suggesting that they are more likely to develop type 2 diabetes, according to the researchers led by Milena Cioana, BHSc, with the department of pediatrics, McMaster University, Hamilton, Ont.

Kelly A. Curran, MD, an assistant professor of pediatrics at the University of Oklahoma Health Sciences Center in Oklahoma City, where she practices adolescent medicine, said in an interview that it has been known that women with PCOS have higher rates of diabetes and many in the field have suspected the relationship is bidirectional.

“In my clinical practice, I’ve seen a high percentage of women with type 2 diabetes present with irregular menses, some of whom have gone on to be diagnosed with PCOS,” said Dr. Curran, who was not involved with the study.

However, she said, she was surprised the prevalence of PCOS reported in this paper – nearly one in five – was so high. Early diagnosis is important for PCOS to prevent complications such as hypertension, hyperglycemia, and dyslipidemia.

Psychiatric conditions are also prevalent in patients with PCOS, including anxiety (18%), depression (16%), and ADHD (9%).

Dr. Curran agreed there is a need to screen for PCOS and to evaluate for other causes of irregular periods in patients with type 2 diabetes.

“Menstrual irregularities are often overlooked in young women without further work-up, especially in patients who have chronic illnesses,” she noted.
 

Results come with a caveat

However, the authors said, results should be viewed with caution because “studies including the larger numbers of girls did not report the criteria used to diagnose PCOS, which is a challenge during adolescence.”

Diagnostic criteria for PCOS during adolescence include the combination of menstrual irregularities according to time since their first period and clinical or biochemical hyperandrogenism after excluding other potential causes.

Dr. Curran explained that PCOS symptoms include irregular periods and acne which can overlap with normal changes in puberty. In her experience, PCOS is often diagnosed without patients meeting full criteria. She agreed further research with standardized criteria is urgently needed.

The European Society of Human Reproduction and Embryology/American Society of Reproductive Medicine, the Pediatric Endocrine Society, and the International Consortium of Paediatric Endocrinology guidelines suggest that using ultrasound to check the size of ovaries could help diagnose PCOS, but other guidelines are more conservative, the authors noted.

They added that “there is a need for a consensus to establish the pediatric criteria for diagnosing PCOS in adolescents to ensure accurate diagnosis and lower the misclassification rates.”
 

Assessing links to obesity and race

Still unclear, the authors wrote, is whether and how obesity and race affect prevalence of PCOS among girls with type 2 diabetes.

The authors wrote: “Although earlier studies suggested that obesity-related insulin resistance and hyperinsulinemia can contribute to PCOS pathogenesis, insulin resistance in patients with PCOS may be present independently of [body mass index]. Obesity seems to increase the risk of PCOS only slightly and might represent a referral bias for PCOS.”

Few studies included in the meta-analysis had race-specific data, so the authors were limited in assessing associations between race and PCOS prevalence.

“However,” they wrote, “our data demonstrate that Indian girls had the highest prevalence, followed by White girls, and then Indigenous girls in Canada.”

Further studies are needed to help define at-risk subgroups and evaluate treatment strategies, the authors noted.

They reported having no relevant financial relationships. Dr. Curran had no conflicts of interest.

Polycystic ovary syndrome is common in girls with type 2 diabetes, findings of a new study suggest, and authors say screening for PCOS is critical in this group.

In a systematic review and meta-analysis involving 470 girls (average age 12.9-16.1 years) with type 2 diabetes in six studies, the prevalence of PCOS was nearly 1 in 5 (19.58%; 95% confidence interval, 12.02%-27.14%; P = .002), substantially higher than that of PCOS in the general adolescent population.

PCOS, a complex endocrine disorder, occurs in 1.14%-11.04% of adolescent girls globally, according to the paper published online in JAMA Network Open.

The secondary outcome studied links to prevalence of PCOS with race and obesity.

Insulin resistance and compensatory hyperinsulinemia are present in 44%-70% of women with PCOS, suggesting that they are more likely to develop type 2 diabetes, according to the researchers led by Milena Cioana, BHSc, with the department of pediatrics, McMaster University, Hamilton, Ont.

Kelly A. Curran, MD, an assistant professor of pediatrics at the University of Oklahoma Health Sciences Center in Oklahoma City, where she practices adolescent medicine, said in an interview that it has been known that women with PCOS have higher rates of diabetes and many in the field have suspected the relationship is bidirectional.

“In my clinical practice, I’ve seen a high percentage of women with type 2 diabetes present with irregular menses, some of whom have gone on to be diagnosed with PCOS,” said Dr. Curran, who was not involved with the study.

However, she said, she was surprised the prevalence of PCOS reported in this paper – nearly one in five – was so high. Early diagnosis is important for PCOS to prevent complications such as hypertension, hyperglycemia, and dyslipidemia.

Psychiatric conditions are also prevalent in patients with PCOS, including anxiety (18%), depression (16%), and ADHD (9%).

Dr. Curran agreed there is a need to screen for PCOS and to evaluate for other causes of irregular periods in patients with type 2 diabetes.

“Menstrual irregularities are often overlooked in young women without further work-up, especially in patients who have chronic illnesses,” she noted.
 

Results come with a caveat

However, the authors said, results should be viewed with caution because “studies including the larger numbers of girls did not report the criteria used to diagnose PCOS, which is a challenge during adolescence.”

Diagnostic criteria for PCOS during adolescence include the combination of menstrual irregularities according to time since their first period and clinical or biochemical hyperandrogenism after excluding other potential causes.

Dr. Curran explained that PCOS symptoms include irregular periods and acne which can overlap with normal changes in puberty. In her experience, PCOS is often diagnosed without patients meeting full criteria. She agreed further research with standardized criteria is urgently needed.

The European Society of Human Reproduction and Embryology/American Society of Reproductive Medicine, the Pediatric Endocrine Society, and the International Consortium of Paediatric Endocrinology guidelines suggest that using ultrasound to check the size of ovaries could help diagnose PCOS, but other guidelines are more conservative, the authors noted.

They added that “there is a need for a consensus to establish the pediatric criteria for diagnosing PCOS in adolescents to ensure accurate diagnosis and lower the misclassification rates.”
 

Assessing links to obesity and race

Still unclear, the authors wrote, is whether and how obesity and race affect prevalence of PCOS among girls with type 2 diabetes.

The authors wrote: “Although earlier studies suggested that obesity-related insulin resistance and hyperinsulinemia can contribute to PCOS pathogenesis, insulin resistance in patients with PCOS may be present independently of [body mass index]. Obesity seems to increase the risk of PCOS only slightly and might represent a referral bias for PCOS.”

Few studies included in the meta-analysis had race-specific data, so the authors were limited in assessing associations between race and PCOS prevalence.

“However,” they wrote, “our data demonstrate that Indian girls had the highest prevalence, followed by White girls, and then Indigenous girls in Canada.”

Further studies are needed to help define at-risk subgroups and evaluate treatment strategies, the authors noted.

They reported having no relevant financial relationships. Dr. Curran had no conflicts of interest.

As an Advanced Practice Provider, when and why might a patient with uterine fibroids be scheduled to visit with you?

Ms. Haibach: Typically, with the flow of how our practice runs, a patient would schedule with me as an initial visit to explore their abnormal or heavy bleeding. Oftentimes, a patient is unsure with what they have going on medically and will view APPs as a safe place to start. Other times, I will see a patient for a general wellness exam who will mention heavier menses over the years or just a change in their bleeding pattern-- longer flow, things like that.

It may stem from something that seems out of the ordinary for them or a symptom impacting their life. For example, if a patient says, “I have to run home and change my clothes,” or “I'm bleeding through my bed sheets.” Those statements prompt further evaluation. At times, patients who have already been diagnosed with fibroids, will come to see me if they have chosen medical management over surgical management of their fibroids. They continue to follow up with me to reevaluate the success of their treatment plan periodically. So, whether I start them on a plan, or a physician does, they can follow up with me to revisit their medical plan and ensure it remains appropriate.

You touched on this a bit, but can you dive deeper into exactly what you are looking for as part of that visit? 

Ms. Haibach: Definitely. With an initial consult to me, the number one question that I would ask my patients first is, what is your most bothersome symptom? With this question, I'm looking to determine: is it pain that brought you to me? Is it heavy bleeding? Do you feel bulk and bloaty? Are you having issues getting pregnant? Do you have bowel or bladder issues?

The information I get from that one initial question, helps guide the remainder of my visit. If bleeding is the main concern, we would focus on getting that under control. So, we need to suppress the menses with medication options. If bulk and bloating is the main concern, for instance the patient feels like they have a pregnant-looking abdomen, typically surgical options are warranted. If the main complaint is infertility, we do have fertility specialists in our practice who remove fibroids to aid patients in achieving pregnancy.

The most important purpose of this visit is to really listen to the patient to find out how these symptoms are impacting their daily lives. From there, I can use that information to guide my treatment plan.

So, once it is determined that the patient is a good surgical candidate, what would be the next steps?

Ms. Haibach: If at the end of my visit, I determine that a patient is potentially a suitable surgical candidate, the first thing I would do is order appropriate imaging. For example, if the patient is interested in uterine preservation for future fertility, she is likely going to opt for a laparoscopic myomectomy, where fibroids would be removed, and her uterus would be left in place. In that case, she would require an MRI for fibroid mapping. If a woman has completed childbearing, then oftentimes a pelvic ultrasound would suffice, at least to start, since she'd likely elect hysterectomy if she has reached her fertility goals.

I would also perform an endometrial biopsy to rule out malignant process before going into surgery. To optimize a patient for our MIGS surgeons, I gather a thorough medical history to ensure their comorbidities are appropriately managed. For example, diabetes is under control, sleep apnea is being treated, no active infections. If there is anything else going on that needs to be addressed, I'd refer them to the appropriate provider first.

Once I have acceptable imaging, a negative endometrial biopsy and an adequate medical history, I would then assist the patient in scheduling with one of the surgeons on my team for a consult and physical exam to determine surgery planning. Once they see our physician, a surgery date is booked. The patient would come back to see me within 30 days of surgery, and we would do a preoperative education appointment. I see them again 2 weeks after surgery for a post-op visit. We’d perform the post-of visit virtually in our practice. We would see the patient sooner if there are any other concerns that arise post-operatively.

What if the patient is not a surgical candidate? How do you as an APP assist in ongoing medical management?

Ms. Haibach: The presence of fibroids alone, without symptoms, often does not require surgical intervention. There are occasions where a patient is, for example, seen in the emergency room for abdominal pain, whereas they’ll get a CT scan of the abdomen pelvis, and a fibroid is incidentally found. At that point, they are instructed to see gynecology for follow-up. If the patient was unaware of the fibroid, has no symptoms and there's no concerning imaging features, then management with ongoing surveillance (repeat imaging and office follow up) and instructions on when to return is usually appropriate.

Depending on the symptoms, medical management typically includes hormonal suppression of menses in the form of a birth control pill or an IUD. If bleeding is the main concern, it is my goal to at least slow her bleeding, if not try to stop it. Not all women are good candidates for hormone therapy, so there is a medication option that is non-hormonal. In my role, I would start a medication plan for a patient and initiate a new medication such as hormonal suppression in the form of birth control, IUD, non-hormonal medications etc.

Typically, when I do that, I'll have the patient follow up with me in about two to three months to reassess the medication’s effectiveness. The goal of the reassessment is to determine if it is working for her life, to be sure there are no major side-effects, and just to make sure she is amenable to the plan. As part of the medical management, sometimes it is necessary to monitor blood counts for anemia to be certain that medical management is still appropriate for her.

From your experience in practicing, are you more likely to be visited by one age bracket or ethnicity over another? 

Ms. Haibach: Actually, data tells us that most fibroids occur in women of reproductive age. They are also diagnosed in African American women two to three times more frequently than in white women. Fibroids are infrequently seen in premenstrual women. A relief of symptoms of the fibroids often occurs at the time of menopause, when the menstrual cyclicity seizes and steroid hormone levels decrease. My demographic is consistent with the above statistics. I tend to see women within the ages of  20’s-50’s and more often African Americans.

Was there anything else that you'd like to mention?

Ms. Haibach: Abnormal bleeding can be very stressful for women. APPs are a great place to start an abnormal bleeding or fibroid work-up. Patients should rest assure that although we cannot perform surgery, APPs can help get them in the right direction for the best care possible.

As an Advanced Practice Provider, when and why might a patient with uterine fibroids be scheduled to visit with you?

Ms. Haibach: Typically, with the flow of how our practice runs, a patient would schedule with me as an initial visit to explore their abnormal or heavy bleeding. Oftentimes, a patient is unsure with what they have going on medically and will view APPs as a safe place to start. Other times, I will see a patient for a general wellness exam who will mention heavier menses over the years or just a change in their bleeding pattern-- longer flow, things like that.

It may stem from something that seems out of the ordinary for them or a symptom impacting their life. For example, if a patient says, “I have to run home and change my clothes,” or “I'm bleeding through my bed sheets.” Those statements prompt further evaluation. At times, patients who have already been diagnosed with fibroids, will come to see me if they have chosen medical management over surgical management of their fibroids. They continue to follow up with me to reevaluate the success of their treatment plan periodically. So, whether I start them on a plan, or a physician does, they can follow up with me to revisit their medical plan and ensure it remains appropriate.

You touched on this a bit, but can you dive deeper into exactly what you are looking for as part of that visit? 

Ms. Haibach: Definitely. With an initial consult to me, the number one question that I would ask my patients first is, what is your most bothersome symptom? With this question, I'm looking to determine: is it pain that brought you to me? Is it heavy bleeding? Do you feel bulk and bloaty? Are you having issues getting pregnant? Do you have bowel or bladder issues?

The information I get from that one initial question, helps guide the remainder of my visit. If bleeding is the main concern, we would focus on getting that under control. So, we need to suppress the menses with medication options. If bulk and bloating is the main concern, for instance the patient feels like they have a pregnant-looking abdomen, typically surgical options are warranted. If the main complaint is infertility, we do have fertility specialists in our practice who remove fibroids to aid patients in achieving pregnancy.

The most important purpose of this visit is to really listen to the patient to find out how these symptoms are impacting their daily lives. From there, I can use that information to guide my treatment plan.

So, once it is determined that the patient is a good surgical candidate, what would be the next steps?

Ms. Haibach: If at the end of my visit, I determine that a patient is potentially a suitable surgical candidate, the first thing I would do is order appropriate imaging. For example, if the patient is interested in uterine preservation for future fertility, she is likely going to opt for a laparoscopic myomectomy, where fibroids would be removed, and her uterus would be left in place. In that case, she would require an MRI for fibroid mapping. If a woman has completed childbearing, then oftentimes a pelvic ultrasound would suffice, at least to start, since she'd likely elect hysterectomy if she has reached her fertility goals.

I would also perform an endometrial biopsy to rule out malignant process before going into surgery. To optimize a patient for our MIGS surgeons, I gather a thorough medical history to ensure their comorbidities are appropriately managed. For example, diabetes is under control, sleep apnea is being treated, no active infections. If there is anything else going on that needs to be addressed, I'd refer them to the appropriate provider first.

Once I have acceptable imaging, a negative endometrial biopsy and an adequate medical history, I would then assist the patient in scheduling with one of the surgeons on my team for a consult and physical exam to determine surgery planning. Once they see our physician, a surgery date is booked. The patient would come back to see me within 30 days of surgery, and we would do a preoperative education appointment. I see them again 2 weeks after surgery for a post-op visit. We’d perform the post-of visit virtually in our practice. We would see the patient sooner if there are any other concerns that arise post-operatively.

What if the patient is not a surgical candidate? How do you as an APP assist in ongoing medical management?

Ms. Haibach: The presence of fibroids alone, without symptoms, often does not require surgical intervention. There are occasions where a patient is, for example, seen in the emergency room for abdominal pain, whereas they’ll get a CT scan of the abdomen pelvis, and a fibroid is incidentally found. At that point, they are instructed to see gynecology for follow-up. If the patient was unaware of the fibroid, has no symptoms and there's no concerning imaging features, then management with ongoing surveillance (repeat imaging and office follow up) and instructions on when to return is usually appropriate.

Depending on the symptoms, medical management typically includes hormonal suppression of menses in the form of a birth control pill or an IUD. If bleeding is the main concern, it is my goal to at least slow her bleeding, if not try to stop it. Not all women are good candidates for hormone therapy, so there is a medication option that is non-hormonal. In my role, I would start a medication plan for a patient and initiate a new medication such as hormonal suppression in the form of birth control, IUD, non-hormonal medications etc.

Typically, when I do that, I'll have the patient follow up with me in about two to three months to reassess the medication’s effectiveness. The goal of the reassessment is to determine if it is working for her life, to be sure there are no major side-effects, and just to make sure she is amenable to the plan. As part of the medical management, sometimes it is necessary to monitor blood counts for anemia to be certain that medical management is still appropriate for her.

From your experience in practicing, are you more likely to be visited by one age bracket or ethnicity over another? 

Ms. Haibach: Actually, data tells us that most fibroids occur in women of reproductive age. They are also diagnosed in African American women two to three times more frequently than in white women. Fibroids are infrequently seen in premenstrual women. A relief of symptoms of the fibroids often occurs at the time of menopause, when the menstrual cyclicity seizes and steroid hormone levels decrease. My demographic is consistent with the above statistics. I tend to see women within the ages of  20’s-50’s and more often African Americans.

Was there anything else that you'd like to mention?

Ms. Haibach: Abnormal bleeding can be very stressful for women. APPs are a great place to start an abnormal bleeding or fibroid work-up. Patients should rest assure that although we cannot perform surgery, APPs can help get them in the right direction for the best care possible.

As an Advanced Practice Provider, when and why might a patient with uterine fibroids be scheduled to visit with you?

Ms. Haibach: Typically, with the flow of how our practice runs, a patient would schedule with me as an initial visit to explore their abnormal or heavy bleeding. Oftentimes, a patient is unsure with what they have going on medically and will view APPs as a safe place to start. Other times, I will see a patient for a general wellness exam who will mention heavier menses over the years or just a change in their bleeding pattern-- longer flow, things like that.

It may stem from something that seems out of the ordinary for them or a symptom impacting their life. For example, if a patient says, “I have to run home and change my clothes,” or “I'm bleeding through my bed sheets.” Those statements prompt further evaluation. At times, patients who have already been diagnosed with fibroids, will come to see me if they have chosen medical management over surgical management of their fibroids. They continue to follow up with me to reevaluate the success of their treatment plan periodically. So, whether I start them on a plan, or a physician does, they can follow up with me to revisit their medical plan and ensure it remains appropriate.

You touched on this a bit, but can you dive deeper into exactly what you are looking for as part of that visit? 

Ms. Haibach: Definitely. With an initial consult to me, the number one question that I would ask my patients first is, what is your most bothersome symptom? With this question, I'm looking to determine: is it pain that brought you to me? Is it heavy bleeding? Do you feel bulk and bloaty? Are you having issues getting pregnant? Do you have bowel or bladder issues?

The information I get from that one initial question, helps guide the remainder of my visit. If bleeding is the main concern, we would focus on getting that under control. So, we need to suppress the menses with medication options. If bulk and bloating is the main concern, for instance the patient feels like they have a pregnant-looking abdomen, typically surgical options are warranted. If the main complaint is infertility, we do have fertility specialists in our practice who remove fibroids to aid patients in achieving pregnancy.

The most important purpose of this visit is to really listen to the patient to find out how these symptoms are impacting their daily lives. From there, I can use that information to guide my treatment plan.

So, once it is determined that the patient is a good surgical candidate, what would be the next steps?

Ms. Haibach: If at the end of my visit, I determine that a patient is potentially a suitable surgical candidate, the first thing I would do is order appropriate imaging. For example, if the patient is interested in uterine preservation for future fertility, she is likely going to opt for a laparoscopic myomectomy, where fibroids would be removed, and her uterus would be left in place. In that case, she would require an MRI for fibroid mapping. If a woman has completed childbearing, then oftentimes a pelvic ultrasound would suffice, at least to start, since she'd likely elect hysterectomy if she has reached her fertility goals.

I would also perform an endometrial biopsy to rule out malignant process before going into surgery. To optimize a patient for our MIGS surgeons, I gather a thorough medical history to ensure their comorbidities are appropriately managed. For example, diabetes is under control, sleep apnea is being treated, no active infections. If there is anything else going on that needs to be addressed, I'd refer them to the appropriate provider first.

Once I have acceptable imaging, a negative endometrial biopsy and an adequate medical history, I would then assist the patient in scheduling with one of the surgeons on my team for a consult and physical exam to determine surgery planning. Once they see our physician, a surgery date is booked. The patient would come back to see me within 30 days of surgery, and we would do a preoperative education appointment. I see them again 2 weeks after surgery for a post-op visit. We’d perform the post-of visit virtually in our practice. We would see the patient sooner if there are any other concerns that arise post-operatively.

What if the patient is not a surgical candidate? How do you as an APP assist in ongoing medical management?

Ms. Haibach: The presence of fibroids alone, without symptoms, often does not require surgical intervention. There are occasions where a patient is, for example, seen in the emergency room for abdominal pain, whereas they’ll get a CT scan of the abdomen pelvis, and a fibroid is incidentally found. At that point, they are instructed to see gynecology for follow-up. If the patient was unaware of the fibroid, has no symptoms and there's no concerning imaging features, then management with ongoing surveillance (repeat imaging and office follow up) and instructions on when to return is usually appropriate.

Depending on the symptoms, medical management typically includes hormonal suppression of menses in the form of a birth control pill or an IUD. If bleeding is the main concern, it is my goal to at least slow her bleeding, if not try to stop it. Not all women are good candidates for hormone therapy, so there is a medication option that is non-hormonal. In my role, I would start a medication plan for a patient and initiate a new medication such as hormonal suppression in the form of birth control, IUD, non-hormonal medications etc.

Typically, when I do that, I'll have the patient follow up with me in about two to three months to reassess the medication’s effectiveness. The goal of the reassessment is to determine if it is working for her life, to be sure there are no major side-effects, and just to make sure she is amenable to the plan. As part of the medical management, sometimes it is necessary to monitor blood counts for anemia to be certain that medical management is still appropriate for her.

From your experience in practicing, are you more likely to be visited by one age bracket or ethnicity over another? 

Ms. Haibach: Actually, data tells us that most fibroids occur in women of reproductive age. They are also diagnosed in African American women two to three times more frequently than in white women. Fibroids are infrequently seen in premenstrual women. A relief of symptoms of the fibroids often occurs at the time of menopause, when the menstrual cyclicity seizes and steroid hormone levels decrease. My demographic is consistent with the above statistics. I tend to see women within the ages of  20’s-50’s and more often African Americans.

Was there anything else that you'd like to mention?

Ms. Haibach: Abnormal bleeding can be very stressful for women. APPs are a great place to start an abnormal bleeding or fibroid work-up. Patients should rest assure that although we cannot perform surgery, APPs can help get them in the right direction for the best care possible.

Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

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

Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

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

Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

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

Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.

Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.

“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.

After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”

Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.

The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.

Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.

“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
 

Hepatitis B screening and vaccination for all pregnant women?

Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.

“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”

If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.

How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.

Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.

Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.

“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.

“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”

One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.

Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.

Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.

“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.

After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”

Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.

The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.

Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.

“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
 

Hepatitis B screening and vaccination for all pregnant women?

Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.

“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”

If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.

How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.

Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.

Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.

“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.

“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”

One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.

Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.

Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.

“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.

After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”

Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.

The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.

Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.

“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
 

Hepatitis B screening and vaccination for all pregnant women?

Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.

“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”

If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.

How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.

Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.

Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.

“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.

“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”

One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.

Women in the United States are less likely to die of ovarian cancer, but more likely to die of endometrial cancer than they were 3 decades ago, according to a recent research letter published in Obstetrics & Gynecology.

“This convergence is because of a steady reduction in the death rate for ovarian cancer, partly because of advances in treatment, alongside a steep increase in the death rate for endometrial cancer,” Rebecca L. Siegel, MPH, corresponding author and senior scientific director of surveillance research at the American Cancer Society, said in an interview. “Endometrial cancer has not had any major treatment advances in 40 years.”

However, Ms. Siegel and colleagues also found Black women had a twofold higher endometrial cancer–related mortality rate over the same time frame, compared with White women. The disparity in endometrial cancer mortality rates for Black women compared with White women is alarming, the authors said, and might be an underestimate because of a higher rate of hysterectomy among Black women.

The researchers analyzed endometrial and ovarian cancer mortality rates from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) with the SEER*Stat software, stratifying the data by whether the person belonged to mutually exclusive racial and ethnic categories of White, Asian or Pacific Islander, Black, or Hispanic. They identified 232,957 women who died from endometrial cancer and 419,085 people who died from ovarian cancer between 1990 and 2019.

Ms. Siegel and colleagues found there was a decrease in ovarian cancer mortality rates between 1990 (9.3 per 100,000 women) and 2019 (6.0 per 100,000 women) (average annual percent change, 22.7%; 95% confidence interval, 23.5%-22.0%). While endometrial cancer mortality decreased between 1990 (4.3 per 100,000 women) and 1997 (4.0 per 100,000 women), it increased between 1997 and 2019 (5.1 per 100,000 women) (average annual percent change, 1.7%; 95% CI, 1.3%-2.1%). When measuring ovarian cancer mortality to endometrial cancer mortality from 1990 (9.3 vs. 4.3 per 100,000), compared with 2019 (6.0 vs. 5.1 per 100,000), there is a significant decline in excess deaths from ovarian cancer.

“Three decades ago, women in the United States were almost twice as likely to die from ovarian cancer as they were to die from endometrial cancer,” Ms. Siegel said in an interview. “Today the difference is only 15% higher, or an excess of less than 1 death per of 100,000 women.”
 

Growing racial disparity in endometrial cancer mortality

While these results persisted for some racial and ethnic subgroups, it did not persist for Black women, who saw an increase in endometrial cancer mortality rate from 7.2 per 100,000 women between 1990 and 1994 to 9.1 per 100,000 women between 2015 and 2019. Compared with White women, there was a significant increase in the mortality rate ratio for uterine cancer for Black women, from 1.83 between 1990 and 1994 (95% CI, 1.77-1.89) to 1.98 between 2015 and 2019 (95% CI, 1.93-2.02) (P < .001).

“Endometrial cancer has one of the largest racial disparities of any cancer. The 5-year relative survival rate for Black women is 63% compared to 84% for White women – a 21% gap in absolute terms. This is largely due to less access to high-quality health care, which is reflected in both later-stage diagnosis and lower survival for every stage of disease,” Ms. Siegel said in an interview. Other factors that contribute include lack of guideline-concordant surgical treatment, and increased risk of aggressive tumor subtypes.

Alex A. Francoeur, MD; and Ritu Salani, MD, MBA, of the department of obstetrics and gynecology at the University of California, Los Angeles, who were not involved in the study, said the research by Ms. Siegel and colleagues “highlights growing disparities in uterine cancer between non-Hispanic Black and non-Hispanic White women.”

“Understanding race as a social, not biological construct, and as a proxy for socioeconomic status, is key to understanding this disparity,” said Dr. Francoeur, a third-year ob.gyn. resident at UCLA Health, and Dr. Salani, an Ob.Gyn. News editorial board member. “For example, many studies cite a more advanced stage at diagnosis as an explanation for racial disparities in endometrial cancer; however, this is a substitute for differences in health care access as well as other socioeconomic factors such as income and education.”

Dr. Francoeur and Dr. Salani also acknowledged other disparities in risk factors may play a role in the differences in endometrial mortality rates such as obesity, which “in non-Hispanic Black women is over 60% greater than non-Hispanic White women.”

In terms of limitations, they noted that SEER’s database is less representative of the population, compared with the United States Cancer Statistics database (36.7% vs. 99%), and that factors such as greater prevalence of hysterectomy may contribute to larger racial disparities.

“Future studies need to examine inequities in treatment by race as well as the importance of health care systems in the stage of diagnosis,” they said.

Ms. Siegel said her team plans to follow the patterns outlined in this analysis and examine factors like cancer subtype, socioeconomic status, and place of residence in the future. “However, health inequalities are rooted in systemic racism, so documentation is necessary but insufficient to effect change, which must occur at the institutional level. A more concerted effort is needed to ensure that every woman receives appropriate treatment, regardless of the color of her skin, and education of providers to reduce racial bias and help increase trust in the health care system should be required.”

The authors reported no relevant financial disclosures. Dr. Francoeur and Dr. Salani reported no relevant financial disclosures.

Women in the United States are less likely to die of ovarian cancer, but more likely to die of endometrial cancer than they were 3 decades ago, according to a recent research letter published in Obstetrics & Gynecology.

“This convergence is because of a steady reduction in the death rate for ovarian cancer, partly because of advances in treatment, alongside a steep increase in the death rate for endometrial cancer,” Rebecca L. Siegel, MPH, corresponding author and senior scientific director of surveillance research at the American Cancer Society, said in an interview. “Endometrial cancer has not had any major treatment advances in 40 years.”

However, Ms. Siegel and colleagues also found Black women had a twofold higher endometrial cancer–related mortality rate over the same time frame, compared with White women. The disparity in endometrial cancer mortality rates for Black women compared with White women is alarming, the authors said, and might be an underestimate because of a higher rate of hysterectomy among Black women.

The researchers analyzed endometrial and ovarian cancer mortality rates from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) with the SEER*Stat software, stratifying the data by whether the person belonged to mutually exclusive racial and ethnic categories of White, Asian or Pacific Islander, Black, or Hispanic. They identified 232,957 women who died from endometrial cancer and 419,085 people who died from ovarian cancer between 1990 and 2019.

Ms. Siegel and colleagues found there was a decrease in ovarian cancer mortality rates between 1990 (9.3 per 100,000 women) and 2019 (6.0 per 100,000 women) (average annual percent change, 22.7%; 95% confidence interval, 23.5%-22.0%). While endometrial cancer mortality decreased between 1990 (4.3 per 100,000 women) and 1997 (4.0 per 100,000 women), it increased between 1997 and 2019 (5.1 per 100,000 women) (average annual percent change, 1.7%; 95% CI, 1.3%-2.1%). When measuring ovarian cancer mortality to endometrial cancer mortality from 1990 (9.3 vs. 4.3 per 100,000), compared with 2019 (6.0 vs. 5.1 per 100,000), there is a significant decline in excess deaths from ovarian cancer.

“Three decades ago, women in the United States were almost twice as likely to die from ovarian cancer as they were to die from endometrial cancer,” Ms. Siegel said in an interview. “Today the difference is only 15% higher, or an excess of less than 1 death per of 100,000 women.”
 

Growing racial disparity in endometrial cancer mortality

While these results persisted for some racial and ethnic subgroups, it did not persist for Black women, who saw an increase in endometrial cancer mortality rate from 7.2 per 100,000 women between 1990 and 1994 to 9.1 per 100,000 women between 2015 and 2019. Compared with White women, there was a significant increase in the mortality rate ratio for uterine cancer for Black women, from 1.83 between 1990 and 1994 (95% CI, 1.77-1.89) to 1.98 between 2015 and 2019 (95% CI, 1.93-2.02) (P < .001).

“Endometrial cancer has one of the largest racial disparities of any cancer. The 5-year relative survival rate for Black women is 63% compared to 84% for White women – a 21% gap in absolute terms. This is largely due to less access to high-quality health care, which is reflected in both later-stage diagnosis and lower survival for every stage of disease,” Ms. Siegel said in an interview. Other factors that contribute include lack of guideline-concordant surgical treatment, and increased risk of aggressive tumor subtypes.

Alex A. Francoeur, MD; and Ritu Salani, MD, MBA, of the department of obstetrics and gynecology at the University of California, Los Angeles, who were not involved in the study, said the research by Ms. Siegel and colleagues “highlights growing disparities in uterine cancer between non-Hispanic Black and non-Hispanic White women.”

“Understanding race as a social, not biological construct, and as a proxy for socioeconomic status, is key to understanding this disparity,” said Dr. Francoeur, a third-year ob.gyn. resident at UCLA Health, and Dr. Salani, an Ob.Gyn. News editorial board member. “For example, many studies cite a more advanced stage at diagnosis as an explanation for racial disparities in endometrial cancer; however, this is a substitute for differences in health care access as well as other socioeconomic factors such as income and education.”

Dr. Francoeur and Dr. Salani also acknowledged other disparities in risk factors may play a role in the differences in endometrial mortality rates such as obesity, which “in non-Hispanic Black women is over 60% greater than non-Hispanic White women.”

In terms of limitations, they noted that SEER’s database is less representative of the population, compared with the United States Cancer Statistics database (36.7% vs. 99%), and that factors such as greater prevalence of hysterectomy may contribute to larger racial disparities.

“Future studies need to examine inequities in treatment by race as well as the importance of health care systems in the stage of diagnosis,” they said.

Ms. Siegel said her team plans to follow the patterns outlined in this analysis and examine factors like cancer subtype, socioeconomic status, and place of residence in the future. “However, health inequalities are rooted in systemic racism, so documentation is necessary but insufficient to effect change, which must occur at the institutional level. A more concerted effort is needed to ensure that every woman receives appropriate treatment, regardless of the color of her skin, and education of providers to reduce racial bias and help increase trust in the health care system should be required.”

The authors reported no relevant financial disclosures. Dr. Francoeur and Dr. Salani reported no relevant financial disclosures.

Women in the United States are less likely to die of ovarian cancer, but more likely to die of endometrial cancer than they were 3 decades ago, according to a recent research letter published in Obstetrics & Gynecology.

“This convergence is because of a steady reduction in the death rate for ovarian cancer, partly because of advances in treatment, alongside a steep increase in the death rate for endometrial cancer,” Rebecca L. Siegel, MPH, corresponding author and senior scientific director of surveillance research at the American Cancer Society, said in an interview. “Endometrial cancer has not had any major treatment advances in 40 years.”

However, Ms. Siegel and colleagues also found Black women had a twofold higher endometrial cancer–related mortality rate over the same time frame, compared with White women. The disparity in endometrial cancer mortality rates for Black women compared with White women is alarming, the authors said, and might be an underestimate because of a higher rate of hysterectomy among Black women.

The researchers analyzed endometrial and ovarian cancer mortality rates from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) with the SEER*Stat software, stratifying the data by whether the person belonged to mutually exclusive racial and ethnic categories of White, Asian or Pacific Islander, Black, or Hispanic. They identified 232,957 women who died from endometrial cancer and 419,085 people who died from ovarian cancer between 1990 and 2019.

Ms. Siegel and colleagues found there was a decrease in ovarian cancer mortality rates between 1990 (9.3 per 100,000 women) and 2019 (6.0 per 100,000 women) (average annual percent change, 22.7%; 95% confidence interval, 23.5%-22.0%). While endometrial cancer mortality decreased between 1990 (4.3 per 100,000 women) and 1997 (4.0 per 100,000 women), it increased between 1997 and 2019 (5.1 per 100,000 women) (average annual percent change, 1.7%; 95% CI, 1.3%-2.1%). When measuring ovarian cancer mortality to endometrial cancer mortality from 1990 (9.3 vs. 4.3 per 100,000), compared with 2019 (6.0 vs. 5.1 per 100,000), there is a significant decline in excess deaths from ovarian cancer.

“Three decades ago, women in the United States were almost twice as likely to die from ovarian cancer as they were to die from endometrial cancer,” Ms. Siegel said in an interview. “Today the difference is only 15% higher, or an excess of less than 1 death per of 100,000 women.”
 

Growing racial disparity in endometrial cancer mortality

While these results persisted for some racial and ethnic subgroups, it did not persist for Black women, who saw an increase in endometrial cancer mortality rate from 7.2 per 100,000 women between 1990 and 1994 to 9.1 per 100,000 women between 2015 and 2019. Compared with White women, there was a significant increase in the mortality rate ratio for uterine cancer for Black women, from 1.83 between 1990 and 1994 (95% CI, 1.77-1.89) to 1.98 between 2015 and 2019 (95% CI, 1.93-2.02) (P < .001).

“Endometrial cancer has one of the largest racial disparities of any cancer. The 5-year relative survival rate for Black women is 63% compared to 84% for White women – a 21% gap in absolute terms. This is largely due to less access to high-quality health care, which is reflected in both later-stage diagnosis and lower survival for every stage of disease,” Ms. Siegel said in an interview. Other factors that contribute include lack of guideline-concordant surgical treatment, and increased risk of aggressive tumor subtypes.

Alex A. Francoeur, MD; and Ritu Salani, MD, MBA, of the department of obstetrics and gynecology at the University of California, Los Angeles, who were not involved in the study, said the research by Ms. Siegel and colleagues “highlights growing disparities in uterine cancer between non-Hispanic Black and non-Hispanic White women.”

“Understanding race as a social, not biological construct, and as a proxy for socioeconomic status, is key to understanding this disparity,” said Dr. Francoeur, a third-year ob.gyn. resident at UCLA Health, and Dr. Salani, an Ob.Gyn. News editorial board member. “For example, many studies cite a more advanced stage at diagnosis as an explanation for racial disparities in endometrial cancer; however, this is a substitute for differences in health care access as well as other socioeconomic factors such as income and education.”

Dr. Francoeur and Dr. Salani also acknowledged other disparities in risk factors may play a role in the differences in endometrial mortality rates such as obesity, which “in non-Hispanic Black women is over 60% greater than non-Hispanic White women.”

In terms of limitations, they noted that SEER’s database is less representative of the population, compared with the United States Cancer Statistics database (36.7% vs. 99%), and that factors such as greater prevalence of hysterectomy may contribute to larger racial disparities.

“Future studies need to examine inequities in treatment by race as well as the importance of health care systems in the stage of diagnosis,” they said.

Ms. Siegel said her team plans to follow the patterns outlined in this analysis and examine factors like cancer subtype, socioeconomic status, and place of residence in the future. “However, health inequalities are rooted in systemic racism, so documentation is necessary but insufficient to effect change, which must occur at the institutional level. A more concerted effort is needed to ensure that every woman receives appropriate treatment, regardless of the color of her skin, and education of providers to reduce racial bias and help increase trust in the health care system should be required.”

The authors reported no relevant financial disclosures. Dr. Francoeur and Dr. Salani reported no relevant financial disclosures.

Screening pregnant women with obesity for gestational diabetes before 20 weeks of pregnancy did not lead to any improved maternal or neonatal outcomes compared with doing routine screening between 24 and 28 weeks, according to research presented Feb. 4 at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is increasing evidence that early screening does not reduce the risk of adverse perinatal outcomes,” Jennifer Thompson, MD, associate professor of ob.gyn. at Vanderbilt University, Nashville, Tenn., said in an interview. “The increasing number of studies that have demonstrated no benefit in reducing adverse perinatal outcomes leads to consideration to revise recommendations for early screening.”

However, she did note that early screening may be helpful in identifying patients with undiagnosed preexisting diabetes.

Michael Richley, MD, a maternal-fetal medicine fellow at the University of California, Los Angeles, said catching those previously undiagnosed cases is one of the goals of earlier screening with the expectation that earlier management will lead to better outcomes.

“If a patient then obtains the diagnosis of type 2 diabetes, introducing nutritional counseling and possible medical management early can lead to better outcomes,” said Dr. Richley, who attended the presentation but was not involved in the research. ”While catching undiagnosed type 2 diabetes is not common, it is becoming increasingly common lately.”

Obesity is a known risk factor for impaired glucose metabolism and for gestational diabetes, explained presenter Christopher A. Enakpene, MD, an ob.gyn. from Midland, Tex., who completed the study while completing his maternal-fetal medicine fellowship at the University of Illinois in Chicago. Dr. Enakpene reminded attendees that the American College of Obstetricians and Gynecologists (ACOG) currently recommends early screening for gestational diabetes in patients with certain risk factors, including obesity, a history of first-degree relatives with diabetes, or a history of gestational diabetes, impaired glucose tolerance, poor pregnancy outcomes, fetal demise, congenital abnormalities, or birth of an infant large for gestational age.

The researchers screened 7,126 patients for enrollment in the study from March 2017 through February 2019 and identified 600 who met the criteria: An adult with a singleton pregnancy and body mass index (BMI) of at least 30 kg/m². Patients were excluded if they had preexisting diabetes, elevated blood glucose or impaired glucose tolerance, a history of gestational diabetes, any chromosomal anomalies or abnormalities in the pregnancy, or were past 20 weeks of pregnancy.

The prospective randomized controlled trial was open label and included 296 patients who were randomly assigned to early screening with a 1-hour glucose challenge test (GCT) and hemoglobin A_1c before 20 weeks, followed by a 3-hour oral glucose tolerance test if the GCT result was between 140 and 200 mg/dL with an HbA_1c of less than 6.5%. The other 304 patients were screened with a 1-hour GCT between 24 and 28 weeks but also had an HbA_1c test before 20 weeks.

The primary outcome was macrosomia, defined as a birth weight at least 4,000 g, with various maternal and neonatal secondary outcomes. The only significant difference between the groups at baseline was a higher proportion of Hispanic participants in the early screening group (22.4%) compared to the routine screening group (13.7%).

The groups had no significant differences in birth weight or macrosomia, which occurred in 2.8% of the early screening group and 3.4% of the routine screening group (P = .7). There were no significant differences in gestational age at delivery, preeclampsia, polyhydramnios, shoulder dystocia, cesarean delivery, or NICU admission. However, the rate of gestational diabetes was significantly higher in the early screening group (22.5%) than in the routine screening group (15.7%; P < .05). In addition, more participants with gestational diabetes in the early screening group used insulin (34.4%) compared with those in the routine screening group (15.6%; P < .05).

Dr. Enakpene noted several reasons that the perinatal outcomes may have been similar between the groups, such as the increased rate of gestational diabetes requiring treatment in the early screening group or a higher proportion of participants using insulin in the early screening group.

“Hence, the similarity in adverse perinatal outcomes between the groups despite a higher proportion of gestational diabetes in the early group might be due to more utilization of insulin,” Dr. Enakpene said.

Dr. Richley was not surprised by the findings and hypothesized that the reason for not seeing a difference in outcomes might relate to using a 20-week cutoff for testing when type 2 diabetes would be evident at any stage of pregnancy.

“It would be interesting to have a study look at diabetes testing exclusively in the first trimester for high-risk patients that looks at neonatal outcomes and see if that would show a difference between the two groups,” Dr. Richley said.

Dr. Thompson was similarly interested in whether 20 weeks was an early enough time for early screening.

”I would also like to know the differences in management between the two groups and if the knowledge of early diagnosis impacted their management, such as timing of medication start, amount of medication required, and how that differed from the standard group,” Dr. Thompson said. ”Since patients with a hemoglobin A_1c > 6.5% or glucose tolerance test > 200 [mg/dL] were excluded, I’m interested in the number of patients that were excluded since they likely have undiagnosed preexisting diabetes, which are the patients that may benefit most from early screening.”

Dr. Richley pointed out that the potential clinical implications of the study are limited right now.

“While their secondary outcomes of neonatal hypoglycemia, method of delivery, and other common obstetrical measures were not different, we cannot draw conclusions from this as the study was not powered to evaluate these findings,” Dr. Richley said. “I do still see a role in early screening for patients with risk factors but favor doing so at the first prenatal visit, whenever that is, as opposed to as late as mid-second trimester, though this is often when a patient’s first interaction with a health care system will be within their pregnancy.”

Dr. Enakpene, Dr. Thompson, and Dr. Richley reported no disclosures. External funding for the study was not noted.

Screening pregnant women with obesity for gestational diabetes before 20 weeks of pregnancy did not lead to any improved maternal or neonatal outcomes compared with doing routine screening between 24 and 28 weeks, according to research presented Feb. 4 at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is increasing evidence that early screening does not reduce the risk of adverse perinatal outcomes,” Jennifer Thompson, MD, associate professor of ob.gyn. at Vanderbilt University, Nashville, Tenn., said in an interview. “The increasing number of studies that have demonstrated no benefit in reducing adverse perinatal outcomes leads to consideration to revise recommendations for early screening.”

However, she did note that early screening may be helpful in identifying patients with undiagnosed preexisting diabetes.

Michael Richley, MD, a maternal-fetal medicine fellow at the University of California, Los Angeles, said catching those previously undiagnosed cases is one of the goals of earlier screening with the expectation that earlier management will lead to better outcomes.

“If a patient then obtains the diagnosis of type 2 diabetes, introducing nutritional counseling and possible medical management early can lead to better outcomes,” said Dr. Richley, who attended the presentation but was not involved in the research. ”While catching undiagnosed type 2 diabetes is not common, it is becoming increasingly common lately.”

Obesity is a known risk factor for impaired glucose metabolism and for gestational diabetes, explained presenter Christopher A. Enakpene, MD, an ob.gyn. from Midland, Tex., who completed the study while completing his maternal-fetal medicine fellowship at the University of Illinois in Chicago. Dr. Enakpene reminded attendees that the American College of Obstetricians and Gynecologists (ACOG) currently recommends early screening for gestational diabetes in patients with certain risk factors, including obesity, a history of first-degree relatives with diabetes, or a history of gestational diabetes, impaired glucose tolerance, poor pregnancy outcomes, fetal demise, congenital abnormalities, or birth of an infant large for gestational age.

The researchers screened 7,126 patients for enrollment in the study from March 2017 through February 2019 and identified 600 who met the criteria: An adult with a singleton pregnancy and body mass index (BMI) of at least 30 kg/m². Patients were excluded if they had preexisting diabetes, elevated blood glucose or impaired glucose tolerance, a history of gestational diabetes, any chromosomal anomalies or abnormalities in the pregnancy, or were past 20 weeks of pregnancy.

The prospective randomized controlled trial was open label and included 296 patients who were randomly assigned to early screening with a 1-hour glucose challenge test (GCT) and hemoglobin A_1c before 20 weeks, followed by a 3-hour oral glucose tolerance test if the GCT result was between 140 and 200 mg/dL with an HbA_1c of less than 6.5%. The other 304 patients were screened with a 1-hour GCT between 24 and 28 weeks but also had an HbA_1c test before 20 weeks.

The primary outcome was macrosomia, defined as a birth weight at least 4,000 g, with various maternal and neonatal secondary outcomes. The only significant difference between the groups at baseline was a higher proportion of Hispanic participants in the early screening group (22.4%) compared to the routine screening group (13.7%).

The groups had no significant differences in birth weight or macrosomia, which occurred in 2.8% of the early screening group and 3.4% of the routine screening group (P = .7). There were no significant differences in gestational age at delivery, preeclampsia, polyhydramnios, shoulder dystocia, cesarean delivery, or NICU admission. However, the rate of gestational diabetes was significantly higher in the early screening group (22.5%) than in the routine screening group (15.7%; P < .05). In addition, more participants with gestational diabetes in the early screening group used insulin (34.4%) compared with those in the routine screening group (15.6%; P < .05).

Dr. Enakpene noted several reasons that the perinatal outcomes may have been similar between the groups, such as the increased rate of gestational diabetes requiring treatment in the early screening group or a higher proportion of participants using insulin in the early screening group.

“Hence, the similarity in adverse perinatal outcomes between the groups despite a higher proportion of gestational diabetes in the early group might be due to more utilization of insulin,” Dr. Enakpene said.

Dr. Richley was not surprised by the findings and hypothesized that the reason for not seeing a difference in outcomes might relate to using a 20-week cutoff for testing when type 2 diabetes would be evident at any stage of pregnancy.

“It would be interesting to have a study look at diabetes testing exclusively in the first trimester for high-risk patients that looks at neonatal outcomes and see if that would show a difference between the two groups,” Dr. Richley said.

Dr. Thompson was similarly interested in whether 20 weeks was an early enough time for early screening.

”I would also like to know the differences in management between the two groups and if the knowledge of early diagnosis impacted their management, such as timing of medication start, amount of medication required, and how that differed from the standard group,” Dr. Thompson said. ”Since patients with a hemoglobin A_1c > 6.5% or glucose tolerance test > 200 [mg/dL] were excluded, I’m interested in the number of patients that were excluded since they likely have undiagnosed preexisting diabetes, which are the patients that may benefit most from early screening.”

Dr. Richley pointed out that the potential clinical implications of the study are limited right now.

“While their secondary outcomes of neonatal hypoglycemia, method of delivery, and other common obstetrical measures were not different, we cannot draw conclusions from this as the study was not powered to evaluate these findings,” Dr. Richley said. “I do still see a role in early screening for patients with risk factors but favor doing so at the first prenatal visit, whenever that is, as opposed to as late as mid-second trimester, though this is often when a patient’s first interaction with a health care system will be within their pregnancy.”

Dr. Enakpene, Dr. Thompson, and Dr. Richley reported no disclosures. External funding for the study was not noted.

Screening pregnant women with obesity for gestational diabetes before 20 weeks of pregnancy did not lead to any improved maternal or neonatal outcomes compared with doing routine screening between 24 and 28 weeks, according to research presented Feb. 4 at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is increasing evidence that early screening does not reduce the risk of adverse perinatal outcomes,” Jennifer Thompson, MD, associate professor of ob.gyn. at Vanderbilt University, Nashville, Tenn., said in an interview. “The increasing number of studies that have demonstrated no benefit in reducing adverse perinatal outcomes leads to consideration to revise recommendations for early screening.”

However, she did note that early screening may be helpful in identifying patients with undiagnosed preexisting diabetes.

Michael Richley, MD, a maternal-fetal medicine fellow at the University of California, Los Angeles, said catching those previously undiagnosed cases is one of the goals of earlier screening with the expectation that earlier management will lead to better outcomes.

“If a patient then obtains the diagnosis of type 2 diabetes, introducing nutritional counseling and possible medical management early can lead to better outcomes,” said Dr. Richley, who attended the presentation but was not involved in the research. ”While catching undiagnosed type 2 diabetes is not common, it is becoming increasingly common lately.”

Obesity is a known risk factor for impaired glucose metabolism and for gestational diabetes, explained presenter Christopher A. Enakpene, MD, an ob.gyn. from Midland, Tex., who completed the study while completing his maternal-fetal medicine fellowship at the University of Illinois in Chicago. Dr. Enakpene reminded attendees that the American College of Obstetricians and Gynecologists (ACOG) currently recommends early screening for gestational diabetes in patients with certain risk factors, including obesity, a history of first-degree relatives with diabetes, or a history of gestational diabetes, impaired glucose tolerance, poor pregnancy outcomes, fetal demise, congenital abnormalities, or birth of an infant large for gestational age.

The researchers screened 7,126 patients for enrollment in the study from March 2017 through February 2019 and identified 600 who met the criteria: An adult with a singleton pregnancy and body mass index (BMI) of at least 30 kg/m². Patients were excluded if they had preexisting diabetes, elevated blood glucose or impaired glucose tolerance, a history of gestational diabetes, any chromosomal anomalies or abnormalities in the pregnancy, or were past 20 weeks of pregnancy.

The prospective randomized controlled trial was open label and included 296 patients who were randomly assigned to early screening with a 1-hour glucose challenge test (GCT) and hemoglobin A_1c before 20 weeks, followed by a 3-hour oral glucose tolerance test if the GCT result was between 140 and 200 mg/dL with an HbA_1c of less than 6.5%. The other 304 patients were screened with a 1-hour GCT between 24 and 28 weeks but also had an HbA_1c test before 20 weeks.

The primary outcome was macrosomia, defined as a birth weight at least 4,000 g, with various maternal and neonatal secondary outcomes. The only significant difference between the groups at baseline was a higher proportion of Hispanic participants in the early screening group (22.4%) compared to the routine screening group (13.7%).

The groups had no significant differences in birth weight or macrosomia, which occurred in 2.8% of the early screening group and 3.4% of the routine screening group (P = .7). There were no significant differences in gestational age at delivery, preeclampsia, polyhydramnios, shoulder dystocia, cesarean delivery, or NICU admission. However, the rate of gestational diabetes was significantly higher in the early screening group (22.5%) than in the routine screening group (15.7%; P < .05). In addition, more participants with gestational diabetes in the early screening group used insulin (34.4%) compared with those in the routine screening group (15.6%; P < .05).

Dr. Enakpene noted several reasons that the perinatal outcomes may have been similar between the groups, such as the increased rate of gestational diabetes requiring treatment in the early screening group or a higher proportion of participants using insulin in the early screening group.

“Hence, the similarity in adverse perinatal outcomes between the groups despite a higher proportion of gestational diabetes in the early group might be due to more utilization of insulin,” Dr. Enakpene said.

Dr. Richley was not surprised by the findings and hypothesized that the reason for not seeing a difference in outcomes might relate to using a 20-week cutoff for testing when type 2 diabetes would be evident at any stage of pregnancy.

“It would be interesting to have a study look at diabetes testing exclusively in the first trimester for high-risk patients that looks at neonatal outcomes and see if that would show a difference between the two groups,” Dr. Richley said.

Dr. Thompson was similarly interested in whether 20 weeks was an early enough time for early screening.

”I would also like to know the differences in management between the two groups and if the knowledge of early diagnosis impacted their management, such as timing of medication start, amount of medication required, and how that differed from the standard group,” Dr. Thompson said. ”Since patients with a hemoglobin A_1c > 6.5% or glucose tolerance test > 200 [mg/dL] were excluded, I’m interested in the number of patients that were excluded since they likely have undiagnosed preexisting diabetes, which are the patients that may benefit most from early screening.”

Dr. Richley pointed out that the potential clinical implications of the study are limited right now.

“While their secondary outcomes of neonatal hypoglycemia, method of delivery, and other common obstetrical measures were not different, we cannot draw conclusions from this as the study was not powered to evaluate these findings,” Dr. Richley said. “I do still see a role in early screening for patients with risk factors but favor doing so at the first prenatal visit, whenever that is, as opposed to as late as mid-second trimester, though this is often when a patient’s first interaction with a health care system will be within their pregnancy.”

Dr. Enakpene, Dr. Thompson, and Dr. Richley reported no disclosures. External funding for the study was not noted.