Women's Health

The rates of osteopenia and osteoporosis among individuals with psoriatic arthritis are comparable to those seen in the general population, research suggests.

The cohort study, published in Arthritis Care & Research, also found that clinicians are likely to refer patients for bone mineral density (BMD) testing based on osteoporosis risk factors or psoriatic arthritis disease severity markers.

Timothy S.H. Kwok, MD, of the University of Toronto, and coauthors wrote that previous research suggested a possible link between psoriatic arthritis and osteoporosis or osteopenia. However, no cohort studies appear to have examined this association.

The study involved 201 individuals with psoriatic arthritis attending a single specialist clinic, who were enrolled in a longitudinal study of psoriatic arthritis (PsA) and who were also referred for BMD testing with dual-energy x-ray absorptiometry.

Of these participants, 13% had a BMD in the osteoporotic range, 45% were in the osteopenic range, and 42% were in the normal range for BMD. The prevalence of osteoporosis observed in the general population aged 50 or above, observed in an earlier large prospective study, ranged from 7% to 16%, and osteopenia ranged from 27% to 46%.

“Our study suggests that patients with PsA have similar BMDs compared to the general population,” the authors wrote.

Researchers did note the suggestion that patients with polyarthritis had lower BMDs over time. Because of the small number of events, this did not achieve statistical significance, but “this relationship warrants further research, given that multiple cohort studies have independently demonstrated polyarticular onset of disease predicting clinical deformities and erosive disease in PsA,” they wrote.

They also saw that patients with increased body mass index had a significant 21% lower odds of having a BMD in the osteoporotic range, while those using biologics had a significant 83% lower odds.

Among participants with BMD scores in the osteopenic or osteoporotic range, these scores were seen in the lumbar spine in 63% of measurements, the femoral neck in 88%, and the total hip in 39%. Mean T-scores for the lumbar spine were –0.30±0.32, and for the femoral neck were –1.10±1.04 and the total hip, –0.45±0.42.

The study also examined what factors were associated with referral for BMD testing. They found that increasing age, menopause, elevated acute phase reactants, or use of biologics, methotrexate, and systemic glucocorticoids were associated with a higher likelihood of undergoing BMD testing.

Noting that the latest Canadian clinical practice guidelines on BMD testing advise that age, menopause, and use of systemic glucocorticoids use are risk factors that should prompt testing, the authors suggested clinicians were using a combination of traditional osteoporosis risk factors and markers of psoriatic disease severity to underpin their decision to refer.

However, they commented that none of the factors associated with a higher likelihood of having a BMD test were actually associated with lower BMD scores.

“This suggests that clinicians may be over-screening patients with PsA for osteopenia/osteoporosis, as they do not appear to be at baseline higher risk for lower BMD scores than the general population,” they wrote. “This is of importance, as there are currently no formal recommendations with regards to the optimal interval or time to commence BMD testing within the recent major PsA guidelines.”

The study was supported by a grant from the Krembil Foundation. No conflicts of interest were declared.

SOURCE: Kwok TSH et al. Arthritis Care Res. 2020 Dec 16. doi: 10.1002/acr.24538.

The rates of osteopenia and osteoporosis among individuals with psoriatic arthritis are comparable to those seen in the general population, research suggests.

The cohort study, published in Arthritis Care & Research, also found that clinicians are likely to refer patients for bone mineral density (BMD) testing based on osteoporosis risk factors or psoriatic arthritis disease severity markers.

Timothy S.H. Kwok, MD, of the University of Toronto, and coauthors wrote that previous research suggested a possible link between psoriatic arthritis and osteoporosis or osteopenia. However, no cohort studies appear to have examined this association.

The study involved 201 individuals with psoriatic arthritis attending a single specialist clinic, who were enrolled in a longitudinal study of psoriatic arthritis (PsA) and who were also referred for BMD testing with dual-energy x-ray absorptiometry.

Of these participants, 13% had a BMD in the osteoporotic range, 45% were in the osteopenic range, and 42% were in the normal range for BMD. The prevalence of osteoporosis observed in the general population aged 50 or above, observed in an earlier large prospective study, ranged from 7% to 16%, and osteopenia ranged from 27% to 46%.

“Our study suggests that patients with PsA have similar BMDs compared to the general population,” the authors wrote.

Researchers did note the suggestion that patients with polyarthritis had lower BMDs over time. Because of the small number of events, this did not achieve statistical significance, but “this relationship warrants further research, given that multiple cohort studies have independently demonstrated polyarticular onset of disease predicting clinical deformities and erosive disease in PsA,” they wrote.

They also saw that patients with increased body mass index had a significant 21% lower odds of having a BMD in the osteoporotic range, while those using biologics had a significant 83% lower odds.

Among participants with BMD scores in the osteopenic or osteoporotic range, these scores were seen in the lumbar spine in 63% of measurements, the femoral neck in 88%, and the total hip in 39%. Mean T-scores for the lumbar spine were –0.30±0.32, and for the femoral neck were –1.10±1.04 and the total hip, –0.45±0.42.

The study also examined what factors were associated with referral for BMD testing. They found that increasing age, menopause, elevated acute phase reactants, or use of biologics, methotrexate, and systemic glucocorticoids were associated with a higher likelihood of undergoing BMD testing.

Noting that the latest Canadian clinical practice guidelines on BMD testing advise that age, menopause, and use of systemic glucocorticoids use are risk factors that should prompt testing, the authors suggested clinicians were using a combination of traditional osteoporosis risk factors and markers of psoriatic disease severity to underpin their decision to refer.

However, they commented that none of the factors associated with a higher likelihood of having a BMD test were actually associated with lower BMD scores.

“This suggests that clinicians may be over-screening patients with PsA for osteopenia/osteoporosis, as they do not appear to be at baseline higher risk for lower BMD scores than the general population,” they wrote. “This is of importance, as there are currently no formal recommendations with regards to the optimal interval or time to commence BMD testing within the recent major PsA guidelines.”

The study was supported by a grant from the Krembil Foundation. No conflicts of interest were declared.

SOURCE: Kwok TSH et al. Arthritis Care Res. 2020 Dec 16. doi: 10.1002/acr.24538.

The rates of osteopenia and osteoporosis among individuals with psoriatic arthritis are comparable to those seen in the general population, research suggests.

The cohort study, published in Arthritis Care & Research, also found that clinicians are likely to refer patients for bone mineral density (BMD) testing based on osteoporosis risk factors or psoriatic arthritis disease severity markers.

Timothy S.H. Kwok, MD, of the University of Toronto, and coauthors wrote that previous research suggested a possible link between psoriatic arthritis and osteoporosis or osteopenia. However, no cohort studies appear to have examined this association.

The study involved 201 individuals with psoriatic arthritis attending a single specialist clinic, who were enrolled in a longitudinal study of psoriatic arthritis (PsA) and who were also referred for BMD testing with dual-energy x-ray absorptiometry.

Of these participants, 13% had a BMD in the osteoporotic range, 45% were in the osteopenic range, and 42% were in the normal range for BMD. The prevalence of osteoporosis observed in the general population aged 50 or above, observed in an earlier large prospective study, ranged from 7% to 16%, and osteopenia ranged from 27% to 46%.

“Our study suggests that patients with PsA have similar BMDs compared to the general population,” the authors wrote.

Researchers did note the suggestion that patients with polyarthritis had lower BMDs over time. Because of the small number of events, this did not achieve statistical significance, but “this relationship warrants further research, given that multiple cohort studies have independently demonstrated polyarticular onset of disease predicting clinical deformities and erosive disease in PsA,” they wrote.

They also saw that patients with increased body mass index had a significant 21% lower odds of having a BMD in the osteoporotic range, while those using biologics had a significant 83% lower odds.

Among participants with BMD scores in the osteopenic or osteoporotic range, these scores were seen in the lumbar spine in 63% of measurements, the femoral neck in 88%, and the total hip in 39%. Mean T-scores for the lumbar spine were –0.30±0.32, and for the femoral neck were –1.10±1.04 and the total hip, –0.45±0.42.

The study also examined what factors were associated with referral for BMD testing. They found that increasing age, menopause, elevated acute phase reactants, or use of biologics, methotrexate, and systemic glucocorticoids were associated with a higher likelihood of undergoing BMD testing.

Noting that the latest Canadian clinical practice guidelines on BMD testing advise that age, menopause, and use of systemic glucocorticoids use are risk factors that should prompt testing, the authors suggested clinicians were using a combination of traditional osteoporosis risk factors and markers of psoriatic disease severity to underpin their decision to refer.

However, they commented that none of the factors associated with a higher likelihood of having a BMD test were actually associated with lower BMD scores.

“This suggests that clinicians may be over-screening patients with PsA for osteopenia/osteoporosis, as they do not appear to be at baseline higher risk for lower BMD scores than the general population,” they wrote. “This is of importance, as there are currently no formal recommendations with regards to the optimal interval or time to commence BMD testing within the recent major PsA guidelines.”

The study was supported by a grant from the Krembil Foundation. No conflicts of interest were declared.

SOURCE: Kwok TSH et al. Arthritis Care Res. 2020 Dec 16. doi: 10.1002/acr.24538.

The majority of women in the United States remain unaware of the benefits breastfeeding offers in reducing the risk of breast cancer, reported Adrienne Hoyt-Austin, DO, and colleagues at University of California, Davis.

oksun70/ThinkStock

Using nationally representative data collected from the 2015-2017 National Survey of Family Growth, Dr. Hoyt-Austin and colleagues analyzed responses to the question: “Do you think that breastfeeding decreases a woman’s chances of getting breast cancer a lot, a little, or not at all, no opinion, or don’t know?” A total of 5,554 female respondents aged 15-49 years participated. The response rate was 66.7%.
 

Multiparous status and education play a role in decreased awareness

Those who had given birth more than once, who had no more than a high school education, or who were U.S.-born Hispanic had the lowest level of awareness, believing that breastfeeding offers only “a little” protection. Of those who were aware of the link, 44% reported that breastfeeding provides “a lot” of protection, and foreign-born participants as well as those who breastfed for more than a year were more likely to conclude that breastfeeding offers “a lot” of protection. The researchers found that neither mammogram or personal family history of breast cancer had any bearing on awareness.

Although multiple studies have found breastfeeding to confer a lower rate of cancer risk, morbidity and mortality, with a 26% lower lifetime risk for those mothers who breastfeed for 12 months or longer, only 36% of women in the United States actually breastfeed.
 

Limited data indicate whether respondents were breastfed themselves

“Public health initiatives must consider the complex roots of disparities in breastfeeding,” noted Dr. Hoyt-Austin and colleagues. They acknowledged the subjectivity of perceptions of “a lot” versus “a little” and noted that the study was limited by a lack of data on whether participants were breastfed themselves.

Clinicians have an opportunity to play a key role in better educating families concerning the benefits of breastfeeding, both for mother and child, they advised. According to one recent study, just 5 minutes of counseling on the benefits of breastfeeding “significantly strengthened women’s intentions to breastfeed.

In a separate interview, Amy E. Cyr, MD, FACS, section of surgical oncology at Washington University, St. Louis, noted that “many breast cancer risk factors – age, sex, family history, and age of menopause – are nonmodifiable.” And while other risk factors, including alcohol use, diet, and exercise are controllable, “pregnancies and breastfeeding don’t always go as planned,” Dr. Cyr added.

“Although Dr. Hoyt-Austin et al. observed that many women aren’t aware that breastfeeding decreases breast cancer risk – or to what extent (they cite a 26% cancer risk reduction after 12 or more months of breastfeeding) – most studies haven’t shown that large a drop in breast cancer risk,“ she pointed out, adding that “I think it’s an overstatement to suggest that breastfeeding reduces cancer risk by ‘a lot,’ as one of the survey choices offered in the study suggests.”

Whether or not a woman breastfeeds depends not only on desire but on social and economic support and biology; for some, breastfeeding simply isn’t an option. “I agree that we should educate women about the benefits of breastfeeding so they can make an informed decision for themselves and their infants, but we also need to acknowledge the complexity of this issue,” she cautioned.

One coauthor reported a travel stipend by the Human Milk Banking Association of North America; Dr. Hoyt-Austin and the other authors had no conflicts of interest to report. Dr. Cyr had no conflicts of interest to report.

SOURCE: Hoyt-Austin A et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004162.

The majority of women in the United States remain unaware of the benefits breastfeeding offers in reducing the risk of breast cancer, reported Adrienne Hoyt-Austin, DO, and colleagues at University of California, Davis.

oksun70/ThinkStock

Using nationally representative data collected from the 2015-2017 National Survey of Family Growth, Dr. Hoyt-Austin and colleagues analyzed responses to the question: “Do you think that breastfeeding decreases a woman’s chances of getting breast cancer a lot, a little, or not at all, no opinion, or don’t know?” A total of 5,554 female respondents aged 15-49 years participated. The response rate was 66.7%.
 

Multiparous status and education play a role in decreased awareness

Those who had given birth more than once, who had no more than a high school education, or who were U.S.-born Hispanic had the lowest level of awareness, believing that breastfeeding offers only “a little” protection. Of those who were aware of the link, 44% reported that breastfeeding provides “a lot” of protection, and foreign-born participants as well as those who breastfed for more than a year were more likely to conclude that breastfeeding offers “a lot” of protection. The researchers found that neither mammogram or personal family history of breast cancer had any bearing on awareness.

Although multiple studies have found breastfeeding to confer a lower rate of cancer risk, morbidity and mortality, with a 26% lower lifetime risk for those mothers who breastfeed for 12 months or longer, only 36% of women in the United States actually breastfeed.
 

Limited data indicate whether respondents were breastfed themselves

“Public health initiatives must consider the complex roots of disparities in breastfeeding,” noted Dr. Hoyt-Austin and colleagues. They acknowledged the subjectivity of perceptions of “a lot” versus “a little” and noted that the study was limited by a lack of data on whether participants were breastfed themselves.

Clinicians have an opportunity to play a key role in better educating families concerning the benefits of breastfeeding, both for mother and child, they advised. According to one recent study, just 5 minutes of counseling on the benefits of breastfeeding “significantly strengthened women’s intentions to breastfeed.

In a separate interview, Amy E. Cyr, MD, FACS, section of surgical oncology at Washington University, St. Louis, noted that “many breast cancer risk factors – age, sex, family history, and age of menopause – are nonmodifiable.” And while other risk factors, including alcohol use, diet, and exercise are controllable, “pregnancies and breastfeeding don’t always go as planned,” Dr. Cyr added.

“Although Dr. Hoyt-Austin et al. observed that many women aren’t aware that breastfeeding decreases breast cancer risk – or to what extent (they cite a 26% cancer risk reduction after 12 or more months of breastfeeding) – most studies haven’t shown that large a drop in breast cancer risk,“ she pointed out, adding that “I think it’s an overstatement to suggest that breastfeeding reduces cancer risk by ‘a lot,’ as one of the survey choices offered in the study suggests.”

Whether or not a woman breastfeeds depends not only on desire but on social and economic support and biology; for some, breastfeeding simply isn’t an option. “I agree that we should educate women about the benefits of breastfeeding so they can make an informed decision for themselves and their infants, but we also need to acknowledge the complexity of this issue,” she cautioned.

One coauthor reported a travel stipend by the Human Milk Banking Association of North America; Dr. Hoyt-Austin and the other authors had no conflicts of interest to report. Dr. Cyr had no conflicts of interest to report.

SOURCE: Hoyt-Austin A et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004162.

The majority of women in the United States remain unaware of the benefits breastfeeding offers in reducing the risk of breast cancer, reported Adrienne Hoyt-Austin, DO, and colleagues at University of California, Davis.

oksun70/ThinkStock

Using nationally representative data collected from the 2015-2017 National Survey of Family Growth, Dr. Hoyt-Austin and colleagues analyzed responses to the question: “Do you think that breastfeeding decreases a woman’s chances of getting breast cancer a lot, a little, or not at all, no opinion, or don’t know?” A total of 5,554 female respondents aged 15-49 years participated. The response rate was 66.7%.
 

Multiparous status and education play a role in decreased awareness

Those who had given birth more than once, who had no more than a high school education, or who were U.S.-born Hispanic had the lowest level of awareness, believing that breastfeeding offers only “a little” protection. Of those who were aware of the link, 44% reported that breastfeeding provides “a lot” of protection, and foreign-born participants as well as those who breastfed for more than a year were more likely to conclude that breastfeeding offers “a lot” of protection. The researchers found that neither mammogram or personal family history of breast cancer had any bearing on awareness.

Although multiple studies have found breastfeeding to confer a lower rate of cancer risk, morbidity and mortality, with a 26% lower lifetime risk for those mothers who breastfeed for 12 months or longer, only 36% of women in the United States actually breastfeed.
 

Limited data indicate whether respondents were breastfed themselves

“Public health initiatives must consider the complex roots of disparities in breastfeeding,” noted Dr. Hoyt-Austin and colleagues. They acknowledged the subjectivity of perceptions of “a lot” versus “a little” and noted that the study was limited by a lack of data on whether participants were breastfed themselves.

Clinicians have an opportunity to play a key role in better educating families concerning the benefits of breastfeeding, both for mother and child, they advised. According to one recent study, just 5 minutes of counseling on the benefits of breastfeeding “significantly strengthened women’s intentions to breastfeed.

In a separate interview, Amy E. Cyr, MD, FACS, section of surgical oncology at Washington University, St. Louis, noted that “many breast cancer risk factors – age, sex, family history, and age of menopause – are nonmodifiable.” And while other risk factors, including alcohol use, diet, and exercise are controllable, “pregnancies and breastfeeding don’t always go as planned,” Dr. Cyr added.

“Although Dr. Hoyt-Austin et al. observed that many women aren’t aware that breastfeeding decreases breast cancer risk – or to what extent (they cite a 26% cancer risk reduction after 12 or more months of breastfeeding) – most studies haven’t shown that large a drop in breast cancer risk,“ she pointed out, adding that “I think it’s an overstatement to suggest that breastfeeding reduces cancer risk by ‘a lot,’ as one of the survey choices offered in the study suggests.”

Whether or not a woman breastfeeds depends not only on desire but on social and economic support and biology; for some, breastfeeding simply isn’t an option. “I agree that we should educate women about the benefits of breastfeeding so they can make an informed decision for themselves and their infants, but we also need to acknowledge the complexity of this issue,” she cautioned.

One coauthor reported a travel stipend by the Human Milk Banking Association of North America; Dr. Hoyt-Austin and the other authors had no conflicts of interest to report. Dr. Cyr had no conflicts of interest to report.

SOURCE: Hoyt-Austin A et al. Obstet Gynecol. 2020 Dec. doi: 10.1097/AOG.0000000000004162.

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

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

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

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

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

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

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

How hospital quality contributes to health disparities

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

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

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

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

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

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

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

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

Study implications

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

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

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

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

Dr. Howell had no financial conflicts to disclose.

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

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

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

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

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

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

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

How hospital quality contributes to health disparities

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

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

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

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

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

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

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

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

Study implications

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

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

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

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

Dr. Howell had no financial conflicts to disclose.

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

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

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

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

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

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

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

How hospital quality contributes to health disparities

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

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

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

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

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

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

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

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

Study implications

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

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

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

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

Dr. Howell had no financial conflicts to disclose.

Researchers in Italy have identified microplastic (MP) fragments in four human placentas that were donated for study after delivery.

curtoicurto/Getty Images

“The presence of MPs in the placenta tissue requires the reconsideration of the immunological mechanism of self-tolerance,” wrote Antonio Ragusa, MD, of San Giovanni Calibita Fatebenefratelli Hospital, Rome, and colleagues. “Placenta represents the interface between the fetus and the environment.”

In a pilot observational study published in Environment International, the researchers used Raman microspectroscopy to analyze placentas from six women with physiological pregnancies for the presence of MPs. MPs were defined as particles smaller than 5 mm resulting from the degradation of plastic in the environment, such as plastic objects, coatings, adhesives, paints, and personal care products. Data from previous studies have shown that MPs can move into living organisms, but this study is the first to identify MPs in human placentas, the researchers said.
 

Polypropylene and pigments identified

A total of 12 microplastic fragments were identified in tissue from the placentas of four women; 5 in the fetal side, 4 in the maternal side, and 3 in the chorioamniotic membranes, which suggests that MPs can reach all levels of placental tissue, the researchers said. Most of the MPs were approximately 10 mcm in size, but two were roughly 5 mcm.

All 12 of the MPs were pigmented; of these, 3 were identified as stained polypropylene and the other 9 contained pigments used in a variety of items including coatings, paints, adhesives, plasters, finger paints, polymers and cosmetics, and personal care products. The researchers used a software program to analyze the pigments and matched them with information from the European Chemical Agency for identification of the commercial name, chemical formula, International Union of Pure and Applied Chemistry name, and Color Index Constitution Number.

The mechanism by which MPs may enter the bloodstream and access the placenta remains unclear, the researchers said. “The most probable transport route for MPs is a mechanism of particle uptake and translocation, already described for the internalization from the gastrointestinal tract. Once MPs have reached the maternal surface of the placenta, as other exogenous materials, they can invade the tissue in depth by several transport mechanisms, both active and passive, that are not clearly understood yet.”

The range in location and characteristics of the particles found in the study suggest that passage of MPs into the placenta may be affected by physiological conditions and genetics, as well as food and lifestyle habits of the patients, the researchers said.

The study findings were limited by several factors including the small sample size and observational study design.

However, the presence of MPs in the placenta could affect the pregnancy in various ways, including immunity, growth factor signaling, maternal-fetal communication, and trafficking of various cell types and macrophages, the researchers wrote. In addition, MPs could have a transgenerational effect on metabolism and reproduction.

“Further studies need to be performed to assess if the presence of MPs in human placenta may trigger immune responses or may lead to the release of toxic contaminants, resulting harmful for pregnancy,” they concluded.
 

Cause for concern, but research gaps remain

“Microplastics are ubiquitous in the environment and are detectable in tissues of humans and wildlife,” Andrea C. Gore, PhD, of the University of Texas, Austin, said in an interview. “To my knowledge, this was never previously shown in the placenta.

“There are two reasons why detection of microplastics in placenta would be concerning,” Dr. Gore explained. “First, microplastics may be endocrine-disrupting chemicals (EDCs), or they may concentrate other chemicals that are EDCs. Second, the developing fetus is exquisitely sensitive to natural hormones, and disruptions by EDCs may lead to both immediate as well as latent health problems.

“Clinicians should be concerned about particulate matter in the placenta, “although the number of particles was very small,” said Dr. Gore. “Out of six women, four had particles in their placentas (total of 12) of which one was confirmed to be a plastic (polypropylene). For the other 11 particles, only the pigments could be identified, so more work is needed to confirm whether they were plastics.

“If I were a clinician discussing this article with my patients, I would point out that, although it is concerning that microparticles are present in placenta, few of them were found, and it is not known whether any chemical is released from the particles or actually reaches the fetal circulation,” Dr. Gore said. “I would use it as a starting point for a conversation about lifestyle during pregnancy and encouraging pregnant women to avoid eating foods stored and/or prepared in plastics.”

The limitations of the study include not only the small sample size, but also that “the type of chemicals in the microplastics is for the most part unknown, making it difficult to assess which (if any) might be EDCs,” Dr. Gore emphasized. In addition, “lifestyle and diet can greatly affect exposures to chemicals, so this needs to be carefully factored into the analysis.” Also, “most of the detected particles are pigments, so connections to plastics (other than the one polypropylene particle) need to be strengthened,” she explained.

“The pathways by which microplastics might get into tissues are still rather speculative, and the mechanisms proposed by the authors (endocytosis, paracellular diffusion, entry via airways) need to be demonstrated,” Dr. Gore concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gore had no conflicts to disclose.

SOURCE: Ragusa A et al. Environ Int. 2020 Dec 2. doi: 10.1016/j.envint.2020.106274.

Researchers in Italy have identified microplastic (MP) fragments in four human placentas that were donated for study after delivery.

curtoicurto/Getty Images

“The presence of MPs in the placenta tissue requires the reconsideration of the immunological mechanism of self-tolerance,” wrote Antonio Ragusa, MD, of San Giovanni Calibita Fatebenefratelli Hospital, Rome, and colleagues. “Placenta represents the interface between the fetus and the environment.”

In a pilot observational study published in Environment International, the researchers used Raman microspectroscopy to analyze placentas from six women with physiological pregnancies for the presence of MPs. MPs were defined as particles smaller than 5 mm resulting from the degradation of plastic in the environment, such as plastic objects, coatings, adhesives, paints, and personal care products. Data from previous studies have shown that MPs can move into living organisms, but this study is the first to identify MPs in human placentas, the researchers said.
 

Polypropylene and pigments identified

A total of 12 microplastic fragments were identified in tissue from the placentas of four women; 5 in the fetal side, 4 in the maternal side, and 3 in the chorioamniotic membranes, which suggests that MPs can reach all levels of placental tissue, the researchers said. Most of the MPs were approximately 10 mcm in size, but two were roughly 5 mcm.

All 12 of the MPs were pigmented; of these, 3 were identified as stained polypropylene and the other 9 contained pigments used in a variety of items including coatings, paints, adhesives, plasters, finger paints, polymers and cosmetics, and personal care products. The researchers used a software program to analyze the pigments and matched them with information from the European Chemical Agency for identification of the commercial name, chemical formula, International Union of Pure and Applied Chemistry name, and Color Index Constitution Number.

The mechanism by which MPs may enter the bloodstream and access the placenta remains unclear, the researchers said. “The most probable transport route for MPs is a mechanism of particle uptake and translocation, already described for the internalization from the gastrointestinal tract. Once MPs have reached the maternal surface of the placenta, as other exogenous materials, they can invade the tissue in depth by several transport mechanisms, both active and passive, that are not clearly understood yet.”

The range in location and characteristics of the particles found in the study suggest that passage of MPs into the placenta may be affected by physiological conditions and genetics, as well as food and lifestyle habits of the patients, the researchers said.

The study findings were limited by several factors including the small sample size and observational study design.

However, the presence of MPs in the placenta could affect the pregnancy in various ways, including immunity, growth factor signaling, maternal-fetal communication, and trafficking of various cell types and macrophages, the researchers wrote. In addition, MPs could have a transgenerational effect on metabolism and reproduction.

“Further studies need to be performed to assess if the presence of MPs in human placenta may trigger immune responses or may lead to the release of toxic contaminants, resulting harmful for pregnancy,” they concluded.
 

Cause for concern, but research gaps remain

“Microplastics are ubiquitous in the environment and are detectable in tissues of humans and wildlife,” Andrea C. Gore, PhD, of the University of Texas, Austin, said in an interview. “To my knowledge, this was never previously shown in the placenta.

“There are two reasons why detection of microplastics in placenta would be concerning,” Dr. Gore explained. “First, microplastics may be endocrine-disrupting chemicals (EDCs), or they may concentrate other chemicals that are EDCs. Second, the developing fetus is exquisitely sensitive to natural hormones, and disruptions by EDCs may lead to both immediate as well as latent health problems.

“Clinicians should be concerned about particulate matter in the placenta, “although the number of particles was very small,” said Dr. Gore. “Out of six women, four had particles in their placentas (total of 12) of which one was confirmed to be a plastic (polypropylene). For the other 11 particles, only the pigments could be identified, so more work is needed to confirm whether they were plastics.

“If I were a clinician discussing this article with my patients, I would point out that, although it is concerning that microparticles are present in placenta, few of them were found, and it is not known whether any chemical is released from the particles or actually reaches the fetal circulation,” Dr. Gore said. “I would use it as a starting point for a conversation about lifestyle during pregnancy and encouraging pregnant women to avoid eating foods stored and/or prepared in plastics.”

The limitations of the study include not only the small sample size, but also that “the type of chemicals in the microplastics is for the most part unknown, making it difficult to assess which (if any) might be EDCs,” Dr. Gore emphasized. In addition, “lifestyle and diet can greatly affect exposures to chemicals, so this needs to be carefully factored into the analysis.” Also, “most of the detected particles are pigments, so connections to plastics (other than the one polypropylene particle) need to be strengthened,” she explained.

“The pathways by which microplastics might get into tissues are still rather speculative, and the mechanisms proposed by the authors (endocytosis, paracellular diffusion, entry via airways) need to be demonstrated,” Dr. Gore concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gore had no conflicts to disclose.

SOURCE: Ragusa A et al. Environ Int. 2020 Dec 2. doi: 10.1016/j.envint.2020.106274.

Researchers in Italy have identified microplastic (MP) fragments in four human placentas that were donated for study after delivery.

curtoicurto/Getty Images

“The presence of MPs in the placenta tissue requires the reconsideration of the immunological mechanism of self-tolerance,” wrote Antonio Ragusa, MD, of San Giovanni Calibita Fatebenefratelli Hospital, Rome, and colleagues. “Placenta represents the interface between the fetus and the environment.”

In a pilot observational study published in Environment International, the researchers used Raman microspectroscopy to analyze placentas from six women with physiological pregnancies for the presence of MPs. MPs were defined as particles smaller than 5 mm resulting from the degradation of plastic in the environment, such as plastic objects, coatings, adhesives, paints, and personal care products. Data from previous studies have shown that MPs can move into living organisms, but this study is the first to identify MPs in human placentas, the researchers said.
 

Polypropylene and pigments identified

A total of 12 microplastic fragments were identified in tissue from the placentas of four women; 5 in the fetal side, 4 in the maternal side, and 3 in the chorioamniotic membranes, which suggests that MPs can reach all levels of placental tissue, the researchers said. Most of the MPs were approximately 10 mcm in size, but two were roughly 5 mcm.

All 12 of the MPs were pigmented; of these, 3 were identified as stained polypropylene and the other 9 contained pigments used in a variety of items including coatings, paints, adhesives, plasters, finger paints, polymers and cosmetics, and personal care products. The researchers used a software program to analyze the pigments and matched them with information from the European Chemical Agency for identification of the commercial name, chemical formula, International Union of Pure and Applied Chemistry name, and Color Index Constitution Number.

The mechanism by which MPs may enter the bloodstream and access the placenta remains unclear, the researchers said. “The most probable transport route for MPs is a mechanism of particle uptake and translocation, already described for the internalization from the gastrointestinal tract. Once MPs have reached the maternal surface of the placenta, as other exogenous materials, they can invade the tissue in depth by several transport mechanisms, both active and passive, that are not clearly understood yet.”

The range in location and characteristics of the particles found in the study suggest that passage of MPs into the placenta may be affected by physiological conditions and genetics, as well as food and lifestyle habits of the patients, the researchers said.

The study findings were limited by several factors including the small sample size and observational study design.

However, the presence of MPs in the placenta could affect the pregnancy in various ways, including immunity, growth factor signaling, maternal-fetal communication, and trafficking of various cell types and macrophages, the researchers wrote. In addition, MPs could have a transgenerational effect on metabolism and reproduction.

“Further studies need to be performed to assess if the presence of MPs in human placenta may trigger immune responses or may lead to the release of toxic contaminants, resulting harmful for pregnancy,” they concluded.
 

Cause for concern, but research gaps remain

“Microplastics are ubiquitous in the environment and are detectable in tissues of humans and wildlife,” Andrea C. Gore, PhD, of the University of Texas, Austin, said in an interview. “To my knowledge, this was never previously shown in the placenta.

“There are two reasons why detection of microplastics in placenta would be concerning,” Dr. Gore explained. “First, microplastics may be endocrine-disrupting chemicals (EDCs), or they may concentrate other chemicals that are EDCs. Second, the developing fetus is exquisitely sensitive to natural hormones, and disruptions by EDCs may lead to both immediate as well as latent health problems.

“Clinicians should be concerned about particulate matter in the placenta, “although the number of particles was very small,” said Dr. Gore. “Out of six women, four had particles in their placentas (total of 12) of which one was confirmed to be a plastic (polypropylene). For the other 11 particles, only the pigments could be identified, so more work is needed to confirm whether they were plastics.

“If I were a clinician discussing this article with my patients, I would point out that, although it is concerning that microparticles are present in placenta, few of them were found, and it is not known whether any chemical is released from the particles or actually reaches the fetal circulation,” Dr. Gore said. “I would use it as a starting point for a conversation about lifestyle during pregnancy and encouraging pregnant women to avoid eating foods stored and/or prepared in plastics.”

The limitations of the study include not only the small sample size, but also that “the type of chemicals in the microplastics is for the most part unknown, making it difficult to assess which (if any) might be EDCs,” Dr. Gore emphasized. In addition, “lifestyle and diet can greatly affect exposures to chemicals, so this needs to be carefully factored into the analysis.” Also, “most of the detected particles are pigments, so connections to plastics (other than the one polypropylene particle) need to be strengthened,” she explained.

“The pathways by which microplastics might get into tissues are still rather speculative, and the mechanisms proposed by the authors (endocytosis, paracellular diffusion, entry via airways) need to be demonstrated,” Dr. Gore concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gore had no conflicts to disclose.

SOURCE: Ragusa A et al. Environ Int. 2020 Dec 2. doi: 10.1016/j.envint.2020.106274.

No maternal viremia, placental infection, or vertical transmission of SARS-CoV-2 occurred during a biorepository study that included 64 women with SARS-CoV-2 infection, researchers reported in JAMA Network Open.

But SARS-CoV-2 antibodies transferred relatively inefficiently across the placenta in the third trimester, which suggests that neonates whose mothers had COVID-19 during pregnancy still may be vulnerable to the virus, the investigators said. Antibodies may transfer more efficiently with second-trimester infections, data from another study indicate.

“These findings suggest that, although low rates of maternal viremia and patterns of placental SARS-CoV-2 receptor distribution may underlie the rarity of vertical transmission, reduced transplacental transfer of anti–SARS-CoV-2 antibodies may leave neonates at risk for infection,” wrote study author Andrea G. Edlow, MD, MSc, and colleagues. Dr. Edlow is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and a maternal-fetal medicine specialist at Massachusetts General Hospital, both in Boston.

In another study published in Cell, the research team found that, unlike with third trimester infections, SARS-CoV-2 antibodies transferred efficiently after infection in the second trimester. “Understanding how de novo antibody transfer varies by trimester may point to critical windows in pregnancy that may be most desirable for induction of antibodies through vaccination to optimize protection for both the mother and her infant,” they wrote.

It is unclear whether antibodies that are elicited by recently authorized vaccines will transfer differently than those elicited by natural infection.
 

Reassurance, questions, and concerns

“Although it is not known whether the inefficient transplacental transfer of antibodies ... will also extend to antibodies elicited by future SARS-CoV-2 vaccines, it underscores the susceptibility of infants,” said Denise J. Jamieson, MD, MPH, of Emory University, Atlanta, and Sonja A. Rasmussen, MD, MS, of the University of Florida, Gainesville, in an editorial accompanying the JAMA Network Open study.

And while the lack of vertical disease transmission in this study is reassuring, more research is needed, according to the director of a federal institute that helped fund the research.

“This study provides some reassurance that SARS-CoV-2 infections during the third trimester are unlikely to pass through the placenta to the fetus, but more research needs to be done to confirm this finding,” said Diana W. Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a news release.

The study authors theorize that the low incidence of maternal viremia and nonoverlapping expression of SARS-CoV-2 receptors ACE2 and TMPRSS2 in the placenta may protect against placental infection and vertical transmission.
 

Testing at 3 centers

To quantify SARS-CoV-2 viral load in maternal and neonatal biofluids and the transplacental passage of anti–SARS-CoV-2 antibodies, Dr. Edlow and collaborators enrolled 127 pregnant women at three tertiary care centers in Boston between April 2 and June 13, 2020. Follow-up occurred through July 10. Researchers tested neonates born to women with SARS-CoV-2 infection by nasopharyngeal swab at age 24 hours.

Of 64 women with SARS-CoV-2 infection, 36% were asymptomatic, 34% had mild disease, 11% had moderate disease, 16% had severe disease, and 3% had critical disease. Viral load analyses did not detect viremia in maternal or cord blood, and there was no evidence of vertical transmission.

Transfer of anti–SARS-CoV-2 antibodies was significantly lower than transfer of anti-influenza antibodies The average cord-to-maternal antibody ratio was 0.72 for anti–receptor binding domain IgG and 0.74 for antinucleocapsid, whereas the ratio for anti-influenza antibodies was 1.44. The expected cord-to-maternal antibody ratio is approximately 1.5 for pathogens such as pertussis, influenza, and measles, the authors noted.

Among participants who tested positive for SARS-CoV-2, 35-week intrauterine fetal demise occurred in an asymptomatic woman, and 22-week neonatal demise secondary to extreme prematurity in the setting of abruption and preterm labor occurred in a symptomatic patient.

Maternal disease severity was significantly associated with detectable respiratory viral load. In addition, disease severity was positively correlated with serum concentration of C-reactive protein and ALT, and negatively correlated with white blood cell count.

In the Cell study that further examined antibody transfer, the investigators focused on maternal and cord blood plasma samples from 22 mother-cord dyads with SARS-CoV-2 infection during pregnancy and 34 uninfected mother-neonate dyads, as well as a second trimester cohort of 29 mother-neonate dyads and a third trimester validation cohort of 28 mother-neonate dyads.
 

Protecting infants

The results support “previous studies that have found that, while intrauterine transmission is possible, it is not common,” Dr. Jamieson and Dr. Rasmussen noted. “Most viral infections can be transmitted transplacentally; however, why some viruses are transmitted relatively easily across the placenta (e.g., HIV, Zika, herpes simplex virus), while others, such as influenza, are transmitted rarely is not well understood.”

Data indicate that infants are at higher risk of severe COVID-19, compared with older children. Nonetheless, research suggests that strict hygiene measures can protect infants born to mothers with SARS-CoV-2 infection, they added.

The research was supported by the National Institutes of Health; the Cystic Fibrosis Foundation; a gift from Mark, Lisa, and Enid Schwartz; and by the Massachusetts General Hospital department of pathology Vickery-Colvin Award and other nonprofit groups. Dr. Edlow, Dr. Jamieson, and Dr. Rasmussen had no conflict of interest disclosures.

The coauthors of both studies disclosed ties to pharmaceutical companies, grants from foundations and government agencies, a patent for a SARS-CoV-2 vaccine, and author royalties from publishers.

[email protected]

No maternal viremia, placental infection, or vertical transmission of SARS-CoV-2 occurred during a biorepository study that included 64 women with SARS-CoV-2 infection, researchers reported in JAMA Network Open.

But SARS-CoV-2 antibodies transferred relatively inefficiently across the placenta in the third trimester, which suggests that neonates whose mothers had COVID-19 during pregnancy still may be vulnerable to the virus, the investigators said. Antibodies may transfer more efficiently with second-trimester infections, data from another study indicate.

“These findings suggest that, although low rates of maternal viremia and patterns of placental SARS-CoV-2 receptor distribution may underlie the rarity of vertical transmission, reduced transplacental transfer of anti–SARS-CoV-2 antibodies may leave neonates at risk for infection,” wrote study author Andrea G. Edlow, MD, MSc, and colleagues. Dr. Edlow is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and a maternal-fetal medicine specialist at Massachusetts General Hospital, both in Boston.

In another study published in Cell, the research team found that, unlike with third trimester infections, SARS-CoV-2 antibodies transferred efficiently after infection in the second trimester. “Understanding how de novo antibody transfer varies by trimester may point to critical windows in pregnancy that may be most desirable for induction of antibodies through vaccination to optimize protection for both the mother and her infant,” they wrote.

It is unclear whether antibodies that are elicited by recently authorized vaccines will transfer differently than those elicited by natural infection.
 

Reassurance, questions, and concerns

“Although it is not known whether the inefficient transplacental transfer of antibodies ... will also extend to antibodies elicited by future SARS-CoV-2 vaccines, it underscores the susceptibility of infants,” said Denise J. Jamieson, MD, MPH, of Emory University, Atlanta, and Sonja A. Rasmussen, MD, MS, of the University of Florida, Gainesville, in an editorial accompanying the JAMA Network Open study.

And while the lack of vertical disease transmission in this study is reassuring, more research is needed, according to the director of a federal institute that helped fund the research.

“This study provides some reassurance that SARS-CoV-2 infections during the third trimester are unlikely to pass through the placenta to the fetus, but more research needs to be done to confirm this finding,” said Diana W. Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a news release.

The study authors theorize that the low incidence of maternal viremia and nonoverlapping expression of SARS-CoV-2 receptors ACE2 and TMPRSS2 in the placenta may protect against placental infection and vertical transmission.
 

Testing at 3 centers

To quantify SARS-CoV-2 viral load in maternal and neonatal biofluids and the transplacental passage of anti–SARS-CoV-2 antibodies, Dr. Edlow and collaborators enrolled 127 pregnant women at three tertiary care centers in Boston between April 2 and June 13, 2020. Follow-up occurred through July 10. Researchers tested neonates born to women with SARS-CoV-2 infection by nasopharyngeal swab at age 24 hours.

Of 64 women with SARS-CoV-2 infection, 36% were asymptomatic, 34% had mild disease, 11% had moderate disease, 16% had severe disease, and 3% had critical disease. Viral load analyses did not detect viremia in maternal or cord blood, and there was no evidence of vertical transmission.

Transfer of anti–SARS-CoV-2 antibodies was significantly lower than transfer of anti-influenza antibodies The average cord-to-maternal antibody ratio was 0.72 for anti–receptor binding domain IgG and 0.74 for antinucleocapsid, whereas the ratio for anti-influenza antibodies was 1.44. The expected cord-to-maternal antibody ratio is approximately 1.5 for pathogens such as pertussis, influenza, and measles, the authors noted.

Among participants who tested positive for SARS-CoV-2, 35-week intrauterine fetal demise occurred in an asymptomatic woman, and 22-week neonatal demise secondary to extreme prematurity in the setting of abruption and preterm labor occurred in a symptomatic patient.

Maternal disease severity was significantly associated with detectable respiratory viral load. In addition, disease severity was positively correlated with serum concentration of C-reactive protein and ALT, and negatively correlated with white blood cell count.

In the Cell study that further examined antibody transfer, the investigators focused on maternal and cord blood plasma samples from 22 mother-cord dyads with SARS-CoV-2 infection during pregnancy and 34 uninfected mother-neonate dyads, as well as a second trimester cohort of 29 mother-neonate dyads and a third trimester validation cohort of 28 mother-neonate dyads.
 

Protecting infants

The results support “previous studies that have found that, while intrauterine transmission is possible, it is not common,” Dr. Jamieson and Dr. Rasmussen noted. “Most viral infections can be transmitted transplacentally; however, why some viruses are transmitted relatively easily across the placenta (e.g., HIV, Zika, herpes simplex virus), while others, such as influenza, are transmitted rarely is not well understood.”

Data indicate that infants are at higher risk of severe COVID-19, compared with older children. Nonetheless, research suggests that strict hygiene measures can protect infants born to mothers with SARS-CoV-2 infection, they added.

The research was supported by the National Institutes of Health; the Cystic Fibrosis Foundation; a gift from Mark, Lisa, and Enid Schwartz; and by the Massachusetts General Hospital department of pathology Vickery-Colvin Award and other nonprofit groups. Dr. Edlow, Dr. Jamieson, and Dr. Rasmussen had no conflict of interest disclosures.

The coauthors of both studies disclosed ties to pharmaceutical companies, grants from foundations and government agencies, a patent for a SARS-CoV-2 vaccine, and author royalties from publishers.

[email protected]

No maternal viremia, placental infection, or vertical transmission of SARS-CoV-2 occurred during a biorepository study that included 64 women with SARS-CoV-2 infection, researchers reported in JAMA Network Open.

But SARS-CoV-2 antibodies transferred relatively inefficiently across the placenta in the third trimester, which suggests that neonates whose mothers had COVID-19 during pregnancy still may be vulnerable to the virus, the investigators said. Antibodies may transfer more efficiently with second-trimester infections, data from another study indicate.

“These findings suggest that, although low rates of maternal viremia and patterns of placental SARS-CoV-2 receptor distribution may underlie the rarity of vertical transmission, reduced transplacental transfer of anti–SARS-CoV-2 antibodies may leave neonates at risk for infection,” wrote study author Andrea G. Edlow, MD, MSc, and colleagues. Dr. Edlow is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and a maternal-fetal medicine specialist at Massachusetts General Hospital, both in Boston.

In another study published in Cell, the research team found that, unlike with third trimester infections, SARS-CoV-2 antibodies transferred efficiently after infection in the second trimester. “Understanding how de novo antibody transfer varies by trimester may point to critical windows in pregnancy that may be most desirable for induction of antibodies through vaccination to optimize protection for both the mother and her infant,” they wrote.

It is unclear whether antibodies that are elicited by recently authorized vaccines will transfer differently than those elicited by natural infection.
 

Reassurance, questions, and concerns

“Although it is not known whether the inefficient transplacental transfer of antibodies ... will also extend to antibodies elicited by future SARS-CoV-2 vaccines, it underscores the susceptibility of infants,” said Denise J. Jamieson, MD, MPH, of Emory University, Atlanta, and Sonja A. Rasmussen, MD, MS, of the University of Florida, Gainesville, in an editorial accompanying the JAMA Network Open study.

And while the lack of vertical disease transmission in this study is reassuring, more research is needed, according to the director of a federal institute that helped fund the research.

“This study provides some reassurance that SARS-CoV-2 infections during the third trimester are unlikely to pass through the placenta to the fetus, but more research needs to be done to confirm this finding,” said Diana W. Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a news release.

The study authors theorize that the low incidence of maternal viremia and nonoverlapping expression of SARS-CoV-2 receptors ACE2 and TMPRSS2 in the placenta may protect against placental infection and vertical transmission.
 

Testing at 3 centers

To quantify SARS-CoV-2 viral load in maternal and neonatal biofluids and the transplacental passage of anti–SARS-CoV-2 antibodies, Dr. Edlow and collaborators enrolled 127 pregnant women at three tertiary care centers in Boston between April 2 and June 13, 2020. Follow-up occurred through July 10. Researchers tested neonates born to women with SARS-CoV-2 infection by nasopharyngeal swab at age 24 hours.

Of 64 women with SARS-CoV-2 infection, 36% were asymptomatic, 34% had mild disease, 11% had moderate disease, 16% had severe disease, and 3% had critical disease. Viral load analyses did not detect viremia in maternal or cord blood, and there was no evidence of vertical transmission.

Transfer of anti–SARS-CoV-2 antibodies was significantly lower than transfer of anti-influenza antibodies The average cord-to-maternal antibody ratio was 0.72 for anti–receptor binding domain IgG and 0.74 for antinucleocapsid, whereas the ratio for anti-influenza antibodies was 1.44. The expected cord-to-maternal antibody ratio is approximately 1.5 for pathogens such as pertussis, influenza, and measles, the authors noted.

Among participants who tested positive for SARS-CoV-2, 35-week intrauterine fetal demise occurred in an asymptomatic woman, and 22-week neonatal demise secondary to extreme prematurity in the setting of abruption and preterm labor occurred in a symptomatic patient.

Maternal disease severity was significantly associated with detectable respiratory viral load. In addition, disease severity was positively correlated with serum concentration of C-reactive protein and ALT, and negatively correlated with white blood cell count.

In the Cell study that further examined antibody transfer, the investigators focused on maternal and cord blood plasma samples from 22 mother-cord dyads with SARS-CoV-2 infection during pregnancy and 34 uninfected mother-neonate dyads, as well as a second trimester cohort of 29 mother-neonate dyads and a third trimester validation cohort of 28 mother-neonate dyads.
 

Protecting infants

The results support “previous studies that have found that, while intrauterine transmission is possible, it is not common,” Dr. Jamieson and Dr. Rasmussen noted. “Most viral infections can be transmitted transplacentally; however, why some viruses are transmitted relatively easily across the placenta (e.g., HIV, Zika, herpes simplex virus), while others, such as influenza, are transmitted rarely is not well understood.”

Data indicate that infants are at higher risk of severe COVID-19, compared with older children. Nonetheless, research suggests that strict hygiene measures can protect infants born to mothers with SARS-CoV-2 infection, they added.

The research was supported by the National Institutes of Health; the Cystic Fibrosis Foundation; a gift from Mark, Lisa, and Enid Schwartz; and by the Massachusetts General Hospital department of pathology Vickery-Colvin Award and other nonprofit groups. Dr. Edlow, Dr. Jamieson, and Dr. Rasmussen had no conflict of interest disclosures.

The coauthors of both studies disclosed ties to pharmaceutical companies, grants from foundations and government agencies, a patent for a SARS-CoV-2 vaccine, and author royalties from publishers.

[email protected]

The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

LoveTheWind/iStock/Getty Images

Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

• Follow a healthy dietary pattern at every life stage.
• Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
• Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
• Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

• Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
• Fruits (especially whole fruit).
• Grains, at least half of which are whole grain. 
• Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
• Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
• Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

LoveTheWind/iStock/Getty Images

Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

• Follow a healthy dietary pattern at every life stage.
• Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
• Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
• Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

• Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
• Fruits (especially whole fruit).
• Grains, at least half of which are whole grain. 
• Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
• Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
• Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

The Department of Agriculture and the Department of Health & Human Services released new dietary guidelines Dec. 29 that for the first time include recommended dietary patterns for infants and toddlers.

LoveTheWind/iStock/Getty Images

Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.

The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.

The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions: 

• Follow a healthy dietary pattern at every life stage.
• Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
• Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
• Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.

The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
 

Proposed cutoffs rejected

The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.

It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.

The agencies published a document explaining why they omitted the advisory committee›s conclusions.

The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.

In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.

“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
 

Guidance for infants and toddlers

The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise. 

At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk. 

The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.

Dr. Elkind highlighted the significance of these additions.

“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
 

For all ages

From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.

According to the guidelines, core elements of a healthy diet include:

• Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
• Fruits (especially whole fruit).
• Grains, at least half of which are whole grain. 
• Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
• Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
• Oils, including vegetable oils and oils in food, such as seafood and nuts.

The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.

Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.

“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”

An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.

The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.

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

Women treated with oral bisphosphonate drugs for osteoporosis for 5 years get no additional benefit – in terms of hip fracture risk – if the treatment is extended for another 5 years, new research shows.

Raycat/Getty Images

“We found that hip fracture risk in women did not differ if women stopped bisphosphonate use after 5 years or stayed on the medication for 10 years,” coauthor Joan C. Lo, MD, Kaiser Permanente Northern California, Oakland, said in an interview.

The new study, published Dec. 7 in JAMA Network Open, did show a small benefit in continuing the treatment through 7 years vs. 5 years, but it wasn’t clear if this was significant.

“Whether there is a benefit to staying on the drug for 7 years needs to be further studied in randomized trials,” Dr. Lo stressed.

It is well established that oral bisphosphonates are effective in reducing the risk for fracture within the first 3-5 years of treatment; however, evidence on the effects of treatment beyond 5 years is lacking.

The most recent guidance from the American Society of Bone and Mineral Research (ASBMR) on the issue, which were released in 2015, recommends continuation of bisphosphonates beyond 5 years for high-risk patients, but it recommends a “drug holiday” for low-risk patients.
 

Study adds important new evidence

However, that guidance acknowledges that data are limited regarding long-term use. This large new study adds important new evidence to the discussion, Robert A. Adler, MD, who was a member of the ASBMR Task Force for the recent guidance, said in an interview.

“[With the lack of recent research,] this new study from Kaiser Permanente is of great interest,” said Dr. Adler, chief of endocrinology and metabolism at Central Virginia Veterans Affairs Health Care System and professor of internal medicine and of epidemiology at Virginia Commonwealth University, Richmond.

“It is new data and suggests we might temper our enthusiasm for long-term treatment with bisphosphonates,” he said.

“Importantly, it is the first large observational trial and is closer to a real-world setting than a randomized controlled trial,” he said.

But, Dr. Adler emphasized: “The take-home message is that while this suggests that patients can probably be given a drug holiday for a couple of years ... they should be retested, and if they appear to be at an increased risk of fracture, they probably should restart again.

“Osteoporosis is a chronic disorder,” he emphasized. “It isn’t cured by any of our treatments, and as people get older, they are at a higher fracture risk.

“So we really need to follow our patients for a lifetime and reassess their fracture risk every couple of years – whether they are still on therapy or on a drug holiday.”
 

Possible that 7 years is better than 5 but remains to be proven

The new study involved data from Kaiser Permanente Northern and Southern California on 29,685 women who had completed 5 years of treatment with oral bisphosphonates, including alendronate, risedronate, or ibandronate, between 2002 and 2014.

Among the women, 11,105 (37%) continued taking the drugs beyond 5 years to 7 years, and 2,725 (9.2%) completed a total of 10 years of treatment.

Their median age was 71. Among those for whom bone mineral density data were available, 37% had osteoporosis after the first 5 years of treatment.

During these 5 years of treatment, 507 hip fractures occurred.

The cumulative incidence of hip fracture among for those who discontinued study therapy at entry, i.e., those who underwent treatment for 5 years, was 23.0 per 1,000 individuals.

After 7 years of treatment, the rate was 20.8 per 1000. For those who continued therapy for 10 years, the rate was 26.8 per 1000 individuals.

The rate in the 7-year treatment group was based on patients taking a 6-month drug holiday after the initial 5 years, but the results are hard to interpret, Dr. Lo said.

“It’s possible that 7 years is better than 5, but this is not a randomized trial, and some of the data analyses done in the study suggest more research should be done to look at a benefit after 7 years.

“At the end of the day, doctors and women need to decide at 5 years what an individual woman’s risk fracture risk is and determine if she should stay on the drug longer,” Dr. Lo emphasized.
 

Limitations: Subgroups not identified, adherence hard to assess

The uncertainty of any benefit of treatment with bisphosphonates beyond 5 years is further reflected in U.S. recommendations – the Food and Drug Administration has concluded on the basis of pooled data from the extension phase of major clinical trials that any advantages of treatment beyond 3-5 years are unclear.

Key limitations of the current study include the fact that the incidence of hip fracture was not evaluated in low-risk vs. high-risk subgroups; therefore, “these findings may not be applicable to older women at higher risk of osteoporotic fracture,” the authors wrote.

Furthermore, the study did not assess outcomes of fractures other than hip fractures, such as vertebral fractures, they noted.

Dr. Adler pointed out that another limitation is that adherence in the trial was defined as taking 60% of prescribed pills.

“I think this is the biggest weakness with the study,” he said. “Particularly with medications like oral bisphosphonates that don’t really make patients feel any different, it’s a real challenge to make sure patients continue to take these drugs properly.”

The findings should give some reassurance for patients who take a break from the drugs after 5 years. However, reassessment of their risk is critical, Dr. Adler reiterated.

The study was supported by a grant from the National Institute on Aging and the National Institute of Arthritis, Musculoskeletal, and Skin Diseases of the National Institutes of Health. The authors and Adler have disclosed no relevant financial relationships.

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

Women treated with oral bisphosphonate drugs for osteoporosis for 5 years get no additional benefit – in terms of hip fracture risk – if the treatment is extended for another 5 years, new research shows.

Raycat/Getty Images

“We found that hip fracture risk in women did not differ if women stopped bisphosphonate use after 5 years or stayed on the medication for 10 years,” coauthor Joan C. Lo, MD, Kaiser Permanente Northern California, Oakland, said in an interview.

The new study, published Dec. 7 in JAMA Network Open, did show a small benefit in continuing the treatment through 7 years vs. 5 years, but it wasn’t clear if this was significant.

“Whether there is a benefit to staying on the drug for 7 years needs to be further studied in randomized trials,” Dr. Lo stressed.

It is well established that oral bisphosphonates are effective in reducing the risk for fracture within the first 3-5 years of treatment; however, evidence on the effects of treatment beyond 5 years is lacking.

The most recent guidance from the American Society of Bone and Mineral Research (ASBMR) on the issue, which were released in 2015, recommends continuation of bisphosphonates beyond 5 years for high-risk patients, but it recommends a “drug holiday” for low-risk patients.
 

Study adds important new evidence

However, that guidance acknowledges that data are limited regarding long-term use. This large new study adds important new evidence to the discussion, Robert A. Adler, MD, who was a member of the ASBMR Task Force for the recent guidance, said in an interview.

“[With the lack of recent research,] this new study from Kaiser Permanente is of great interest,” said Dr. Adler, chief of endocrinology and metabolism at Central Virginia Veterans Affairs Health Care System and professor of internal medicine and of epidemiology at Virginia Commonwealth University, Richmond.

“It is new data and suggests we might temper our enthusiasm for long-term treatment with bisphosphonates,” he said.

“Importantly, it is the first large observational trial and is closer to a real-world setting than a randomized controlled trial,” he said.

But, Dr. Adler emphasized: “The take-home message is that while this suggests that patients can probably be given a drug holiday for a couple of years ... they should be retested, and if they appear to be at an increased risk of fracture, they probably should restart again.

“Osteoporosis is a chronic disorder,” he emphasized. “It isn’t cured by any of our treatments, and as people get older, they are at a higher fracture risk.

“So we really need to follow our patients for a lifetime and reassess their fracture risk every couple of years – whether they are still on therapy or on a drug holiday.”
 

Possible that 7 years is better than 5 but remains to be proven

The new study involved data from Kaiser Permanente Northern and Southern California on 29,685 women who had completed 5 years of treatment with oral bisphosphonates, including alendronate, risedronate, or ibandronate, between 2002 and 2014.

Among the women, 11,105 (37%) continued taking the drugs beyond 5 years to 7 years, and 2,725 (9.2%) completed a total of 10 years of treatment.

Their median age was 71. Among those for whom bone mineral density data were available, 37% had osteoporosis after the first 5 years of treatment.

During these 5 years of treatment, 507 hip fractures occurred.

The cumulative incidence of hip fracture among for those who discontinued study therapy at entry, i.e., those who underwent treatment for 5 years, was 23.0 per 1,000 individuals.

After 7 years of treatment, the rate was 20.8 per 1000. For those who continued therapy for 10 years, the rate was 26.8 per 1000 individuals.

The rate in the 7-year treatment group was based on patients taking a 6-month drug holiday after the initial 5 years, but the results are hard to interpret, Dr. Lo said.

“It’s possible that 7 years is better than 5, but this is not a randomized trial, and some of the data analyses done in the study suggest more research should be done to look at a benefit after 7 years.

“At the end of the day, doctors and women need to decide at 5 years what an individual woman’s risk fracture risk is and determine if she should stay on the drug longer,” Dr. Lo emphasized.
 

Limitations: Subgroups not identified, adherence hard to assess

The uncertainty of any benefit of treatment with bisphosphonates beyond 5 years is further reflected in U.S. recommendations – the Food and Drug Administration has concluded on the basis of pooled data from the extension phase of major clinical trials that any advantages of treatment beyond 3-5 years are unclear.

Key limitations of the current study include the fact that the incidence of hip fracture was not evaluated in low-risk vs. high-risk subgroups; therefore, “these findings may not be applicable to older women at higher risk of osteoporotic fracture,” the authors wrote.

Furthermore, the study did not assess outcomes of fractures other than hip fractures, such as vertebral fractures, they noted.

Dr. Adler pointed out that another limitation is that adherence in the trial was defined as taking 60% of prescribed pills.

“I think this is the biggest weakness with the study,” he said. “Particularly with medications like oral bisphosphonates that don’t really make patients feel any different, it’s a real challenge to make sure patients continue to take these drugs properly.”

The findings should give some reassurance for patients who take a break from the drugs after 5 years. However, reassessment of their risk is critical, Dr. Adler reiterated.

The study was supported by a grant from the National Institute on Aging and the National Institute of Arthritis, Musculoskeletal, and Skin Diseases of the National Institutes of Health. The authors and Adler have disclosed no relevant financial relationships.

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

Women treated with oral bisphosphonate drugs for osteoporosis for 5 years get no additional benefit – in terms of hip fracture risk – if the treatment is extended for another 5 years, new research shows.

Raycat/Getty Images

“We found that hip fracture risk in women did not differ if women stopped bisphosphonate use after 5 years or stayed on the medication for 10 years,” coauthor Joan C. Lo, MD, Kaiser Permanente Northern California, Oakland, said in an interview.

The new study, published Dec. 7 in JAMA Network Open, did show a small benefit in continuing the treatment through 7 years vs. 5 years, but it wasn’t clear if this was significant.

“Whether there is a benefit to staying on the drug for 7 years needs to be further studied in randomized trials,” Dr. Lo stressed.

It is well established that oral bisphosphonates are effective in reducing the risk for fracture within the first 3-5 years of treatment; however, evidence on the effects of treatment beyond 5 years is lacking.

The most recent guidance from the American Society of Bone and Mineral Research (ASBMR) on the issue, which were released in 2015, recommends continuation of bisphosphonates beyond 5 years for high-risk patients, but it recommends a “drug holiday” for low-risk patients.
 

Study adds important new evidence

However, that guidance acknowledges that data are limited regarding long-term use. This large new study adds important new evidence to the discussion, Robert A. Adler, MD, who was a member of the ASBMR Task Force for the recent guidance, said in an interview.

“[With the lack of recent research,] this new study from Kaiser Permanente is of great interest,” said Dr. Adler, chief of endocrinology and metabolism at Central Virginia Veterans Affairs Health Care System and professor of internal medicine and of epidemiology at Virginia Commonwealth University, Richmond.

“It is new data and suggests we might temper our enthusiasm for long-term treatment with bisphosphonates,” he said.

“Importantly, it is the first large observational trial and is closer to a real-world setting than a randomized controlled trial,” he said.

But, Dr. Adler emphasized: “The take-home message is that while this suggests that patients can probably be given a drug holiday for a couple of years ... they should be retested, and if they appear to be at an increased risk of fracture, they probably should restart again.

“Osteoporosis is a chronic disorder,” he emphasized. “It isn’t cured by any of our treatments, and as people get older, they are at a higher fracture risk.

“So we really need to follow our patients for a lifetime and reassess their fracture risk every couple of years – whether they are still on therapy or on a drug holiday.”
 

Possible that 7 years is better than 5 but remains to be proven

The new study involved data from Kaiser Permanente Northern and Southern California on 29,685 women who had completed 5 years of treatment with oral bisphosphonates, including alendronate, risedronate, or ibandronate, between 2002 and 2014.

Among the women, 11,105 (37%) continued taking the drugs beyond 5 years to 7 years, and 2,725 (9.2%) completed a total of 10 years of treatment.

Their median age was 71. Among those for whom bone mineral density data were available, 37% had osteoporosis after the first 5 years of treatment.

During these 5 years of treatment, 507 hip fractures occurred.

The cumulative incidence of hip fracture among for those who discontinued study therapy at entry, i.e., those who underwent treatment for 5 years, was 23.0 per 1,000 individuals.

After 7 years of treatment, the rate was 20.8 per 1000. For those who continued therapy for 10 years, the rate was 26.8 per 1000 individuals.

The rate in the 7-year treatment group was based on patients taking a 6-month drug holiday after the initial 5 years, but the results are hard to interpret, Dr. Lo said.

“It’s possible that 7 years is better than 5, but this is not a randomized trial, and some of the data analyses done in the study suggest more research should be done to look at a benefit after 7 years.

“At the end of the day, doctors and women need to decide at 5 years what an individual woman’s risk fracture risk is and determine if she should stay on the drug longer,” Dr. Lo emphasized.
 

Limitations: Subgroups not identified, adherence hard to assess

The uncertainty of any benefit of treatment with bisphosphonates beyond 5 years is further reflected in U.S. recommendations – the Food and Drug Administration has concluded on the basis of pooled data from the extension phase of major clinical trials that any advantages of treatment beyond 3-5 years are unclear.

Key limitations of the current study include the fact that the incidence of hip fracture was not evaluated in low-risk vs. high-risk subgroups; therefore, “these findings may not be applicable to older women at higher risk of osteoporotic fracture,” the authors wrote.

Furthermore, the study did not assess outcomes of fractures other than hip fractures, such as vertebral fractures, they noted.

Dr. Adler pointed out that another limitation is that adherence in the trial was defined as taking 60% of prescribed pills.

“I think this is the biggest weakness with the study,” he said. “Particularly with medications like oral bisphosphonates that don’t really make patients feel any different, it’s a real challenge to make sure patients continue to take these drugs properly.”

The findings should give some reassurance for patients who take a break from the drugs after 5 years. However, reassessment of their risk is critical, Dr. Adler reiterated.

The study was supported by a grant from the National Institute on Aging and the National Institute of Arthritis, Musculoskeletal, and Skin Diseases of the National Institutes of Health. The authors and Adler have disclosed no relevant financial relationships.

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

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

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

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

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

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

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

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

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

Opioid use in pregnancy spiked in recent decades

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

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

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

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

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

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

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

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

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

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

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

Compassionate care for cannabis users

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

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

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

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

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

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

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

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

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

Questions answered

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

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

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

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

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

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

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

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

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

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

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

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

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

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

Opioid use in pregnancy spiked in recent decades

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

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

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

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

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

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

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

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

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

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

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

Compassionate care for cannabis users

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

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

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

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

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

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

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

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

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

Questions answered

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

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

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

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

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

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

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

No amount of alcohol is safe

Highwaystarz-Photography/Thinkstock

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

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

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

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

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

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

Opioid use in pregnancy spiked in recent decades

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

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

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

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

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

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

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

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

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

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

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

Compassionate care for cannabis users

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

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

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

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

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

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

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

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

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

Questions answered

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

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

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

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

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

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

About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.

The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.

The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.

Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.

Protecting intended parents and carriers

“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”

ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.

“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”

Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.

“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”

A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.

To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.

Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.

Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).

When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.

Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).

An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).

Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
 

The role of agencies

About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.

Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”

Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.

[email protected]

SOURCE: Stark B et al. ASRM 2020, Abstract O-251.

About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.

The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.

The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.

Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.

Protecting intended parents and carriers

“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”

ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.

“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”

Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.

“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”

A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.

To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.

Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.

Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).

When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.

Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).

An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).

Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
 

The role of agencies

About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.

Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”

Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.

[email protected]

SOURCE: Stark B et al. ASRM 2020, Abstract O-251.

About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.

The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.

The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.

Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.

Protecting intended parents and carriers

“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”

ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.

“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”

Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.

“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”

A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.

To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.

Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.

Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).

When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.

Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).

An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).

Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
 

The role of agencies

About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.

Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”

Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.

[email protected]

SOURCE: Stark B et al. ASRM 2020, Abstract O-251.

COVID-19 vaccines should not be withheld from people who are pregnant or lactating and want to be vaccinated, despite a lack of safety data in these populations, according to guidance from the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.

Thye Aun Ngo/Fotolia.com

Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.

“Pregnant women who experience fever following vaccination should be counseled to take acetaminophen,” the advisory notes.

In addition, women do not need to avoid pregnancy after receiving the Pfizer-BioNTech COVID-19 vaccine, according to the CDC’s interim clinical considerations for its use. The U.S. Food and Drug Administration issued an emergency use authorization for the vaccine on Dec. 11.

Although investigators excluded pregnant women from clinical trials, experts believe that mRNA vaccines, which are not live vaccines, “are unlikely to pose a risk for people who are pregnant” and “are not thought to be a risk to the breastfeeding infant,” the CDC notes.

Meanwhile, women who are pregnant may be at greater risk of severe COVID-19, even though the absolute risk of severe illness is low. COVID-19 also may increase the risk of adverse pregnancy outcomes, such as preterm birth, although the data have been mixed with some studies finding an association and others not.

“If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., health care personnel), they may choose to be vaccinated,” the CDC advises. “A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19. While a conversation with a health care provider may be helpful, it is not required prior to vaccination.”
 

Acknowledging side effects and uncertainty

ACOG’s advisory reiterates that approach. The group notes that, based on the mRNA vaccine’s mechanism of action and its safety and efficacy in clinical trials, “it is expected that the safety and efficacy profile of the vaccine for pregnant individuals would be similar to that observed in nonpregnant individuals ... That said, there are no safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown.” 

In clinical trials, most participants experienced mild influenza-like symptoms following vaccination, including injection site reactions, fatigue, chills, muscle and joint pain, and headache. Among participants aged 18-55 years, fever greater than 38°C occurred in 3.7% of participants after the first dose and in 15.8% after the second dose. Most symptoms resolved within a few days. 

Women who are pregnant should treat fever with acetaminophen because “fever has been associated with adverse pregnancy outcomes,” according to the ACOG guidance. “Acetaminophen has been proven to be safe for use in pregnancy and does not appear to impact antibody response to COVID-19 vaccines.” Patients may treat other vaccine side effects, such as injection-site soreness with acetaminophen as well.

When counseling patients, clinicians should explain that side effects are a normal part of developing antibodies to protect against COVID-19. “Regardless of their decision,” the group says, “these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.”
 

More data expected

Data from developmental and reproductive toxicity studies in animals are expected soon, the CDC said. In addition, the manufacturer is following clinical trial participants who became pregnant during the study. 

Women who are pregnant and their physicians should weigh factors such as the extent of COVID-19 transmission in the community, the patient’s risk of contracting COVID-19, risks of COVID-19 to the patient and fetus, vaccine efficacy and side effects, and the lack of data about COVID-19 vaccination during pregnancy.

The Society for Maternal-Fetal Medicine recommends that pregnant and lactating women have access to COVID-19 vaccines in general and has advocated for the inclusion of women who are pregnant or lactating in vaccine trials. The society has suggested that health care professionals “counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low.” It published resources this week for physicians and patients focused on COVID-19 vaccination and pregnancy.

In a review published online Dec. 10 in the American Journal of Obstetrics & Gynecology MFM, Amanda M. Craig, MD, of Duke University Health System in Durham, N.C., and coauthors note that there “is a theoretical risk for fetal harm from any untested medical intervention and this is no different for COVID-19 vaccines.”

“Pregnant individuals should be given the opportunity, along with their obstetric provider, to weigh the potential risk of severe maternal disease against the unknown risk of fetal exposure, and make an autonomous decision about whether or not to accept vaccine until pregnancy safety data are available,” they write.

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

COVID-19 vaccines should not be withheld from people who are pregnant or lactating and want to be vaccinated, despite a lack of safety data in these populations, according to guidance from the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.

Thye Aun Ngo/Fotolia.com

Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.

“Pregnant women who experience fever following vaccination should be counseled to take acetaminophen,” the advisory notes.

In addition, women do not need to avoid pregnancy after receiving the Pfizer-BioNTech COVID-19 vaccine, according to the CDC’s interim clinical considerations for its use. The U.S. Food and Drug Administration issued an emergency use authorization for the vaccine on Dec. 11.

Although investigators excluded pregnant women from clinical trials, experts believe that mRNA vaccines, which are not live vaccines, “are unlikely to pose a risk for people who are pregnant” and “are not thought to be a risk to the breastfeeding infant,” the CDC notes.

Meanwhile, women who are pregnant may be at greater risk of severe COVID-19, even though the absolute risk of severe illness is low. COVID-19 also may increase the risk of adverse pregnancy outcomes, such as preterm birth, although the data have been mixed with some studies finding an association and others not.

“If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., health care personnel), they may choose to be vaccinated,” the CDC advises. “A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19. While a conversation with a health care provider may be helpful, it is not required prior to vaccination.”
 

Acknowledging side effects and uncertainty

ACOG’s advisory reiterates that approach. The group notes that, based on the mRNA vaccine’s mechanism of action and its safety and efficacy in clinical trials, “it is expected that the safety and efficacy profile of the vaccine for pregnant individuals would be similar to that observed in nonpregnant individuals ... That said, there are no safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown.” 

In clinical trials, most participants experienced mild influenza-like symptoms following vaccination, including injection site reactions, fatigue, chills, muscle and joint pain, and headache. Among participants aged 18-55 years, fever greater than 38°C occurred in 3.7% of participants after the first dose and in 15.8% after the second dose. Most symptoms resolved within a few days. 

Women who are pregnant should treat fever with acetaminophen because “fever has been associated with adverse pregnancy outcomes,” according to the ACOG guidance. “Acetaminophen has been proven to be safe for use in pregnancy and does not appear to impact antibody response to COVID-19 vaccines.” Patients may treat other vaccine side effects, such as injection-site soreness with acetaminophen as well.

When counseling patients, clinicians should explain that side effects are a normal part of developing antibodies to protect against COVID-19. “Regardless of their decision,” the group says, “these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.”
 

More data expected

Data from developmental and reproductive toxicity studies in animals are expected soon, the CDC said. In addition, the manufacturer is following clinical trial participants who became pregnant during the study. 

Women who are pregnant and their physicians should weigh factors such as the extent of COVID-19 transmission in the community, the patient’s risk of contracting COVID-19, risks of COVID-19 to the patient and fetus, vaccine efficacy and side effects, and the lack of data about COVID-19 vaccination during pregnancy.

The Society for Maternal-Fetal Medicine recommends that pregnant and lactating women have access to COVID-19 vaccines in general and has advocated for the inclusion of women who are pregnant or lactating in vaccine trials. The society has suggested that health care professionals “counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low.” It published resources this week for physicians and patients focused on COVID-19 vaccination and pregnancy.

In a review published online Dec. 10 in the American Journal of Obstetrics & Gynecology MFM, Amanda M. Craig, MD, of Duke University Health System in Durham, N.C., and coauthors note that there “is a theoretical risk for fetal harm from any untested medical intervention and this is no different for COVID-19 vaccines.”

“Pregnant individuals should be given the opportunity, along with their obstetric provider, to weigh the potential risk of severe maternal disease against the unknown risk of fetal exposure, and make an autonomous decision about whether or not to accept vaccine until pregnancy safety data are available,” they write.

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

COVID-19 vaccines should not be withheld from people who are pregnant or lactating and want to be vaccinated, despite a lack of safety data in these populations, according to guidance from the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.

Thye Aun Ngo/Fotolia.com

Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.

“Pregnant women who experience fever following vaccination should be counseled to take acetaminophen,” the advisory notes.

In addition, women do not need to avoid pregnancy after receiving the Pfizer-BioNTech COVID-19 vaccine, according to the CDC’s interim clinical considerations for its use. The U.S. Food and Drug Administration issued an emergency use authorization for the vaccine on Dec. 11.

Although investigators excluded pregnant women from clinical trials, experts believe that mRNA vaccines, which are not live vaccines, “are unlikely to pose a risk for people who are pregnant” and “are not thought to be a risk to the breastfeeding infant,” the CDC notes.

Meanwhile, women who are pregnant may be at greater risk of severe COVID-19, even though the absolute risk of severe illness is low. COVID-19 also may increase the risk of adverse pregnancy outcomes, such as preterm birth, although the data have been mixed with some studies finding an association and others not.

“If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., health care personnel), they may choose to be vaccinated,” the CDC advises. “A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19. While a conversation with a health care provider may be helpful, it is not required prior to vaccination.”
 

Acknowledging side effects and uncertainty

ACOG’s advisory reiterates that approach. The group notes that, based on the mRNA vaccine’s mechanism of action and its safety and efficacy in clinical trials, “it is expected that the safety and efficacy profile of the vaccine for pregnant individuals would be similar to that observed in nonpregnant individuals ... That said, there are no safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown.” 

In clinical trials, most participants experienced mild influenza-like symptoms following vaccination, including injection site reactions, fatigue, chills, muscle and joint pain, and headache. Among participants aged 18-55 years, fever greater than 38°C occurred in 3.7% of participants after the first dose and in 15.8% after the second dose. Most symptoms resolved within a few days. 

Women who are pregnant should treat fever with acetaminophen because “fever has been associated with adverse pregnancy outcomes,” according to the ACOG guidance. “Acetaminophen has been proven to be safe for use in pregnancy and does not appear to impact antibody response to COVID-19 vaccines.” Patients may treat other vaccine side effects, such as injection-site soreness with acetaminophen as well.

When counseling patients, clinicians should explain that side effects are a normal part of developing antibodies to protect against COVID-19. “Regardless of their decision,” the group says, “these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.”
 

More data expected

Data from developmental and reproductive toxicity studies in animals are expected soon, the CDC said. In addition, the manufacturer is following clinical trial participants who became pregnant during the study. 

Women who are pregnant and their physicians should weigh factors such as the extent of COVID-19 transmission in the community, the patient’s risk of contracting COVID-19, risks of COVID-19 to the patient and fetus, vaccine efficacy and side effects, and the lack of data about COVID-19 vaccination during pregnancy.

The Society for Maternal-Fetal Medicine recommends that pregnant and lactating women have access to COVID-19 vaccines in general and has advocated for the inclusion of women who are pregnant or lactating in vaccine trials. The society has suggested that health care professionals “counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low.” It published resources this week for physicians and patients focused on COVID-19 vaccination and pregnancy.

In a review published online Dec. 10 in the American Journal of Obstetrics & Gynecology MFM, Amanda M. Craig, MD, of Duke University Health System in Durham, N.C., and coauthors note that there “is a theoretical risk for fetal harm from any untested medical intervention and this is no different for COVID-19 vaccines.”

“Pregnant individuals should be given the opportunity, along with their obstetric provider, to weigh the potential risk of severe maternal disease against the unknown risk of fetal exposure, and make an autonomous decision about whether or not to accept vaccine until pregnancy safety data are available,” they write.

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