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Knotless, absorbable sutures best staples for postcesarean skin closure
LAS VEGAS – compared with staples, in a single-site, retrospective study.
For women whose skin incisions were closed with knotless sutures, mean surgical time was 38 minutes; for women who received a staple closure, mean surgical time was 44 minutes (P less than .001). Also, fewer women whose incisions were closed with knotless sutures experienced surgical bleeding greater than 1,000 mL, compared with those who received staples (0.3% vs. 3.0%; P less than .001).
Two previous randomized, controlled trials comparing knotless sutures with staples for skin closure after cesarean delivery were small and had methodological limitations, Inna Bleicher, MD, said in an interview during a poster session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Dr. Bleicher and her colleagues reviewed records from 2,173 elective cesarean deliveries over a period of 4 years. Absorbable, antibacterial, knotless sutures were used for closure for 1,172 women, while staples were used for the remaining 1,001 women.
Over the study period, Dr. Bleicher noted that there was a gradual transition from the use of staples to absorbable, knotless sutures, which also were increasingly used for the hysterotomy closure. She added that, in conversation with peers at Bnai-Zion Medical Center, Haifa, Israel, where she practices as an ob.gyn, she’s found that physicians find the sutures easy and quick to use, because the sutures are double ended, allowing the possibility for two operators to work together in wound closure.
The study’s primary outcome measure was the rate of postoperative infection, defined as postoperative white blood count greater than 18,000 per microliter and antimicrobial treatment. Secondary outcome measures included C-reactive protein levels, hospital readmission for infection related to the delivery, duration of surgery, and surgical blood loss estimated at 1,000 mL or more.
A higher proportion of women in the staple closure group than the knotless suture group required postsurgical antibiotic treatment (11% vs. 10%), but this difference didn’t reach statistical significance (P = .243).
There were no significant differences in the groups in terms of maternal age (about 32 years), or gestational age at delivery (about 39 weeks).
“Our results suggest that cesarean scar skin closure with antibacterial knotless sutures did not increase, and may even reduce, the rates of postoperative infection, morbidity, surgical blood loss, and may shorten operation time,” wrote Dr. Bleicher and her colleagues.
Dr. Bleicher reported no outside sources of funding and no conflicts of interest.
SOURCE: Bleicher I et al. Am J Obstet Gynecol. 2019 Jan. 220;1:S622, Abstract 966.
LAS VEGAS – compared with staples, in a single-site, retrospective study.
For women whose skin incisions were closed with knotless sutures, mean surgical time was 38 minutes; for women who received a staple closure, mean surgical time was 44 minutes (P less than .001). Also, fewer women whose incisions were closed with knotless sutures experienced surgical bleeding greater than 1,000 mL, compared with those who received staples (0.3% vs. 3.0%; P less than .001).
Two previous randomized, controlled trials comparing knotless sutures with staples for skin closure after cesarean delivery were small and had methodological limitations, Inna Bleicher, MD, said in an interview during a poster session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Dr. Bleicher and her colleagues reviewed records from 2,173 elective cesarean deliveries over a period of 4 years. Absorbable, antibacterial, knotless sutures were used for closure for 1,172 women, while staples were used for the remaining 1,001 women.
Over the study period, Dr. Bleicher noted that there was a gradual transition from the use of staples to absorbable, knotless sutures, which also were increasingly used for the hysterotomy closure. She added that, in conversation with peers at Bnai-Zion Medical Center, Haifa, Israel, where she practices as an ob.gyn, she’s found that physicians find the sutures easy and quick to use, because the sutures are double ended, allowing the possibility for two operators to work together in wound closure.
The study’s primary outcome measure was the rate of postoperative infection, defined as postoperative white blood count greater than 18,000 per microliter and antimicrobial treatment. Secondary outcome measures included C-reactive protein levels, hospital readmission for infection related to the delivery, duration of surgery, and surgical blood loss estimated at 1,000 mL or more.
A higher proportion of women in the staple closure group than the knotless suture group required postsurgical antibiotic treatment (11% vs. 10%), but this difference didn’t reach statistical significance (P = .243).
There were no significant differences in the groups in terms of maternal age (about 32 years), or gestational age at delivery (about 39 weeks).
“Our results suggest that cesarean scar skin closure with antibacterial knotless sutures did not increase, and may even reduce, the rates of postoperative infection, morbidity, surgical blood loss, and may shorten operation time,” wrote Dr. Bleicher and her colleagues.
Dr. Bleicher reported no outside sources of funding and no conflicts of interest.
SOURCE: Bleicher I et al. Am J Obstet Gynecol. 2019 Jan. 220;1:S622, Abstract 966.
LAS VEGAS – compared with staples, in a single-site, retrospective study.
For women whose skin incisions were closed with knotless sutures, mean surgical time was 38 minutes; for women who received a staple closure, mean surgical time was 44 minutes (P less than .001). Also, fewer women whose incisions were closed with knotless sutures experienced surgical bleeding greater than 1,000 mL, compared with those who received staples (0.3% vs. 3.0%; P less than .001).
Two previous randomized, controlled trials comparing knotless sutures with staples for skin closure after cesarean delivery were small and had methodological limitations, Inna Bleicher, MD, said in an interview during a poster session at the meeting sponsored by the Society for Maternal-Fetal Medicine.
Dr. Bleicher and her colleagues reviewed records from 2,173 elective cesarean deliveries over a period of 4 years. Absorbable, antibacterial, knotless sutures were used for closure for 1,172 women, while staples were used for the remaining 1,001 women.
Over the study period, Dr. Bleicher noted that there was a gradual transition from the use of staples to absorbable, knotless sutures, which also were increasingly used for the hysterotomy closure. She added that, in conversation with peers at Bnai-Zion Medical Center, Haifa, Israel, where she practices as an ob.gyn, she’s found that physicians find the sutures easy and quick to use, because the sutures are double ended, allowing the possibility for two operators to work together in wound closure.
The study’s primary outcome measure was the rate of postoperative infection, defined as postoperative white blood count greater than 18,000 per microliter and antimicrobial treatment. Secondary outcome measures included C-reactive protein levels, hospital readmission for infection related to the delivery, duration of surgery, and surgical blood loss estimated at 1,000 mL or more.
A higher proportion of women in the staple closure group than the knotless suture group required postsurgical antibiotic treatment (11% vs. 10%), but this difference didn’t reach statistical significance (P = .243).
There were no significant differences in the groups in terms of maternal age (about 32 years), or gestational age at delivery (about 39 weeks).
“Our results suggest that cesarean scar skin closure with antibacterial knotless sutures did not increase, and may even reduce, the rates of postoperative infection, morbidity, surgical blood loss, and may shorten operation time,” wrote Dr. Bleicher and her colleagues.
Dr. Bleicher reported no outside sources of funding and no conflicts of interest.
SOURCE: Bleicher I et al. Am J Obstet Gynecol. 2019 Jan. 220;1:S622, Abstract 966.
REPORTING FROM THE PREGNANCY MEETING
Rapid preeclampsia urine test is simple, noninvasive
according to a research letter in EClinicalMedicine.
The research team, led by Kara M. Rood, MD, of the department of obstetrics and gynecology at the Ohio State University, Columbus, said that their pragmatic study in 346 consecutive pregnant patients demonstrated that the test is not only inexpensive, but also easy to use and well received by the nursing staff. A positive Congo Red Dot Rapid Paper Test had 80% sensitivity, 89% specificity, 92% negative predictive value and 87% accuracy to correctly diagnose preeclampsia.
The patients were recruited from the labor and delivery triage unit at the Ohio State University Wexner Medical Center. Certain misfolded proteins typically are found in the urine of women with preeclampsia, so in prior research, the researchers had hypothesized that a urine test that could detect these proteins would carry “diagnostic and prognostic potential for” preeclampsia. The researchers were able to show that this was possible with a laboratory test that used Congo Red dye because those misfolded proteins bind with it. This current study explored the accuracy of a 3-minute, point-of-care urine test that uses a dot of Congo Red dye on a piece of paper.
Other serum and urine tests, which often have been more complicated or time intensive, have failed to gain traction in real-world practice, as well as in low-resource countries where mortality and morbidity from preeclampsia are highest, the authors noted. By contrast, the researchers hope the rapid paper test they studied in the current research will fulfill that unmet need.
The study was funded by the Saving Lives at Birth grant and a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Rood KM et al. EClinicalMedicine. 2019. doi: 10.1016/j.eclinm.2019.02.004.
according to a research letter in EClinicalMedicine.
The research team, led by Kara M. Rood, MD, of the department of obstetrics and gynecology at the Ohio State University, Columbus, said that their pragmatic study in 346 consecutive pregnant patients demonstrated that the test is not only inexpensive, but also easy to use and well received by the nursing staff. A positive Congo Red Dot Rapid Paper Test had 80% sensitivity, 89% specificity, 92% negative predictive value and 87% accuracy to correctly diagnose preeclampsia.
The patients were recruited from the labor and delivery triage unit at the Ohio State University Wexner Medical Center. Certain misfolded proteins typically are found in the urine of women with preeclampsia, so in prior research, the researchers had hypothesized that a urine test that could detect these proteins would carry “diagnostic and prognostic potential for” preeclampsia. The researchers were able to show that this was possible with a laboratory test that used Congo Red dye because those misfolded proteins bind with it. This current study explored the accuracy of a 3-minute, point-of-care urine test that uses a dot of Congo Red dye on a piece of paper.
Other serum and urine tests, which often have been more complicated or time intensive, have failed to gain traction in real-world practice, as well as in low-resource countries where mortality and morbidity from preeclampsia are highest, the authors noted. By contrast, the researchers hope the rapid paper test they studied in the current research will fulfill that unmet need.
The study was funded by the Saving Lives at Birth grant and a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Rood KM et al. EClinicalMedicine. 2019. doi: 10.1016/j.eclinm.2019.02.004.
according to a research letter in EClinicalMedicine.
The research team, led by Kara M. Rood, MD, of the department of obstetrics and gynecology at the Ohio State University, Columbus, said that their pragmatic study in 346 consecutive pregnant patients demonstrated that the test is not only inexpensive, but also easy to use and well received by the nursing staff. A positive Congo Red Dot Rapid Paper Test had 80% sensitivity, 89% specificity, 92% negative predictive value and 87% accuracy to correctly diagnose preeclampsia.
The patients were recruited from the labor and delivery triage unit at the Ohio State University Wexner Medical Center. Certain misfolded proteins typically are found in the urine of women with preeclampsia, so in prior research, the researchers had hypothesized that a urine test that could detect these proteins would carry “diagnostic and prognostic potential for” preeclampsia. The researchers were able to show that this was possible with a laboratory test that used Congo Red dye because those misfolded proteins bind with it. This current study explored the accuracy of a 3-minute, point-of-care urine test that uses a dot of Congo Red dye on a piece of paper.
Other serum and urine tests, which often have been more complicated or time intensive, have failed to gain traction in real-world practice, as well as in low-resource countries where mortality and morbidity from preeclampsia are highest, the authors noted. By contrast, the researchers hope the rapid paper test they studied in the current research will fulfill that unmet need.
The study was funded by the Saving Lives at Birth grant and a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
SOURCE: Rood KM et al. EClinicalMedicine. 2019. doi: 10.1016/j.eclinm.2019.02.004.
FROM ECLINICALMEDICINE
Sex differences in MS: It’s the chromosomes, not just the hormones
DALLAS – Hormonal differences are not the only reason that multiple sclerosis (MS) disease progression and severity differ between the sexes, according to Rhonda Voskuhl, MD, who delivered the Kenneth P. Johnson Memorial Lecture at a meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis.
“Sex differences in disease are widely prevalent across immunological and neurological diseases. For example, lupus affects women 9:1 more frequently, rheumatoid arthritis is about 3:1, and MS is 3:1,” said Dr. Voskuhl, director of the MS program and Jack H. Skirball Chair of Multiple Sclerosis Research at the University of California, Los Angeles.
However, although women are more likely to experience these diseases, men are often more severely affected by them, Dr. Voskuhl said. “Sometimes in neurodegenerative diseases like MS, we’re seeing that the men, although they get it less frequently, they do worse. ... So these are actually two very important sex differences in disease, one affecting susceptibility and frequency, and the other affecting how they do over the long run with respect to their progression and severity.”
This clinically apparent observation, known for decades, prompted Dr. Voskuhl and others to parse why sex differences exist in this gamut of diseases.
A novel animal model – the four-core genotype mouse model – has allowed Dr. Voskuhl and others to discern the contributions of hormonal versus chromosomal influences on disease susceptibility and progression. The model separates the sex chromosome complement (XX or XY) from gonadal influences, and it’s been extremely helpful in revealing the surprising influence that sex chromosomes play in MS and similar diseases, said Dr. Voskuhl in an interview.
Dr. Voskuhl is also the president-elect of the Organization for the Study of Sex Differences.
DALLAS – Hormonal differences are not the only reason that multiple sclerosis (MS) disease progression and severity differ between the sexes, according to Rhonda Voskuhl, MD, who delivered the Kenneth P. Johnson Memorial Lecture at a meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis.
“Sex differences in disease are widely prevalent across immunological and neurological diseases. For example, lupus affects women 9:1 more frequently, rheumatoid arthritis is about 3:1, and MS is 3:1,” said Dr. Voskuhl, director of the MS program and Jack H. Skirball Chair of Multiple Sclerosis Research at the University of California, Los Angeles.
However, although women are more likely to experience these diseases, men are often more severely affected by them, Dr. Voskuhl said. “Sometimes in neurodegenerative diseases like MS, we’re seeing that the men, although they get it less frequently, they do worse. ... So these are actually two very important sex differences in disease, one affecting susceptibility and frequency, and the other affecting how they do over the long run with respect to their progression and severity.”
This clinically apparent observation, known for decades, prompted Dr. Voskuhl and others to parse why sex differences exist in this gamut of diseases.
A novel animal model – the four-core genotype mouse model – has allowed Dr. Voskuhl and others to discern the contributions of hormonal versus chromosomal influences on disease susceptibility and progression. The model separates the sex chromosome complement (XX or XY) from gonadal influences, and it’s been extremely helpful in revealing the surprising influence that sex chromosomes play in MS and similar diseases, said Dr. Voskuhl in an interview.
Dr. Voskuhl is also the president-elect of the Organization for the Study of Sex Differences.
DALLAS – Hormonal differences are not the only reason that multiple sclerosis (MS) disease progression and severity differ between the sexes, according to Rhonda Voskuhl, MD, who delivered the Kenneth P. Johnson Memorial Lecture at a meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis.
“Sex differences in disease are widely prevalent across immunological and neurological diseases. For example, lupus affects women 9:1 more frequently, rheumatoid arthritis is about 3:1, and MS is 3:1,” said Dr. Voskuhl, director of the MS program and Jack H. Skirball Chair of Multiple Sclerosis Research at the University of California, Los Angeles.
However, although women are more likely to experience these diseases, men are often more severely affected by them, Dr. Voskuhl said. “Sometimes in neurodegenerative diseases like MS, we’re seeing that the men, although they get it less frequently, they do worse. ... So these are actually two very important sex differences in disease, one affecting susceptibility and frequency, and the other affecting how they do over the long run with respect to their progression and severity.”
This clinically apparent observation, known for decades, prompted Dr. Voskuhl and others to parse why sex differences exist in this gamut of diseases.
A novel animal model – the four-core genotype mouse model – has allowed Dr. Voskuhl and others to discern the contributions of hormonal versus chromosomal influences on disease susceptibility and progression. The model separates the sex chromosome complement (XX or XY) from gonadal influences, and it’s been extremely helpful in revealing the surprising influence that sex chromosomes play in MS and similar diseases, said Dr. Voskuhl in an interview.
Dr. Voskuhl is also the president-elect of the Organization for the Study of Sex Differences.
REPORTING FROM ACTRIMS FORUM 2019
Financial toxicity may be common in gynecologic cancer patients
HONOLULU – Financial toxicity may be common among gynecologic cancer patients starting a new line of treatment, based on the results of a survey presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
More than half of the 121 patients surveyed reported mild, moderate, or severe financial toxicity, Margaret Liang, MD, of University of Alabama at Birmingham, said in presenting the findings.
Younger age and lower income were both risk factors for financial toxicity, and having insurance did not protect patients from financial toxicity. Dr. Liang noted that insurance coverage “was not protective for financial toxicity, as the majority of those who screened positive for financial toxicity were insured.” Specifically, 89% of patients with financial toxicity and 98% of patients without it were insured (P = .07).
“This finding supports financial toxicity screening regardless of insurance status and may favor universal screening,” Dr. Liang said.
She and her colleagues conducted the survey of 121 gynecologic cancer patients who had started a new line of systemic therapy in the previous 8 weeks.
The patients’ mean age was 59 years (range, 33-80), and 58% were starting their first line of systemic therapy. Half of the patients had a household income below $40,000, and about one-third of the patients were employed. Most had private (74%) or public (20%) insurance, and 7% of patients were uninsured.
To assess financial toxicity, the researchers used the Comprehensive Score for Financial Toxicity (COST). A score of less than 26 was used as a threshold of financial toxicity. The severity of financial toxicity was graded on a scale of 1 to 4, with a lower score indicating worse toxicity.
Patients were most concerned about having enough money to cover the cost of treatment. Patients reported the lowest mean score—0.97—in response to the statement, “I know that I have enough money in savings, retirement, or assets to cover the costs of my treatment.”
Patients were least concerned about losing their job or income. They reported the highest mean score—3.29—in response to the statement, “I am concerned about keeping my job and income, including working at home.” However, as Dr. Liang pointed out, only one-third of patients were employed at baseline.
In all, 54% of patients reported financial toxicity—37% mild, 16% moderate, and 1% severe.
Dr. Liang and her colleagues found that younger age and lower income were associated with an increased risk for financial toxicity. The mean age was 57 years in patients with financial toxicity and 62 years in patients without it (P = .02). Household incomes were below $40,000 in 63% of patients with financial toxicity and 34% of those without it (P less than .01).
The researchers also found that patients with financial toxicity were significantly more likely to say their cancer diagnosis resulted in lost wages, borrowed money, altered spending habits, the need to sacrifice other things, and not paying bills on time (P less than .01 for all).
On the other hand, patients with financial toxicity were not significantly more likely to become unemployed, file for bankruptcy, sell their house, or get a second job due to their cancer diagnosis.
However, it’s important to note that these data were collected within 8 weeks of patients starting their new line of therapy. The final survey results will include follow-up at 3 months and 6 months.
Dr. Liang said the fact that more than half of patients reported financial toxicity within 8 weeks of starting a new line of therapy suggests early interventions are needed to prevent or reduce financial toxicity. This may include counseling patients on anticipated costs of care, screening for financial toxicity, and linking patients to available financial resources.
Dr. Liang had no financial disclosures.
SOURCE: Liang M et al. SGO 2019. Abstract 8.
HONOLULU – Financial toxicity may be common among gynecologic cancer patients starting a new line of treatment, based on the results of a survey presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
More than half of the 121 patients surveyed reported mild, moderate, or severe financial toxicity, Margaret Liang, MD, of University of Alabama at Birmingham, said in presenting the findings.
Younger age and lower income were both risk factors for financial toxicity, and having insurance did not protect patients from financial toxicity. Dr. Liang noted that insurance coverage “was not protective for financial toxicity, as the majority of those who screened positive for financial toxicity were insured.” Specifically, 89% of patients with financial toxicity and 98% of patients without it were insured (P = .07).
“This finding supports financial toxicity screening regardless of insurance status and may favor universal screening,” Dr. Liang said.
She and her colleagues conducted the survey of 121 gynecologic cancer patients who had started a new line of systemic therapy in the previous 8 weeks.
The patients’ mean age was 59 years (range, 33-80), and 58% were starting their first line of systemic therapy. Half of the patients had a household income below $40,000, and about one-third of the patients were employed. Most had private (74%) or public (20%) insurance, and 7% of patients were uninsured.
To assess financial toxicity, the researchers used the Comprehensive Score for Financial Toxicity (COST). A score of less than 26 was used as a threshold of financial toxicity. The severity of financial toxicity was graded on a scale of 1 to 4, with a lower score indicating worse toxicity.
Patients were most concerned about having enough money to cover the cost of treatment. Patients reported the lowest mean score—0.97—in response to the statement, “I know that I have enough money in savings, retirement, or assets to cover the costs of my treatment.”
Patients were least concerned about losing their job or income. They reported the highest mean score—3.29—in response to the statement, “I am concerned about keeping my job and income, including working at home.” However, as Dr. Liang pointed out, only one-third of patients were employed at baseline.
In all, 54% of patients reported financial toxicity—37% mild, 16% moderate, and 1% severe.
Dr. Liang and her colleagues found that younger age and lower income were associated with an increased risk for financial toxicity. The mean age was 57 years in patients with financial toxicity and 62 years in patients without it (P = .02). Household incomes were below $40,000 in 63% of patients with financial toxicity and 34% of those without it (P less than .01).
The researchers also found that patients with financial toxicity were significantly more likely to say their cancer diagnosis resulted in lost wages, borrowed money, altered spending habits, the need to sacrifice other things, and not paying bills on time (P less than .01 for all).
On the other hand, patients with financial toxicity were not significantly more likely to become unemployed, file for bankruptcy, sell their house, or get a second job due to their cancer diagnosis.
However, it’s important to note that these data were collected within 8 weeks of patients starting their new line of therapy. The final survey results will include follow-up at 3 months and 6 months.
Dr. Liang said the fact that more than half of patients reported financial toxicity within 8 weeks of starting a new line of therapy suggests early interventions are needed to prevent or reduce financial toxicity. This may include counseling patients on anticipated costs of care, screening for financial toxicity, and linking patients to available financial resources.
Dr. Liang had no financial disclosures.
SOURCE: Liang M et al. SGO 2019. Abstract 8.
HONOLULU – Financial toxicity may be common among gynecologic cancer patients starting a new line of treatment, based on the results of a survey presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
More than half of the 121 patients surveyed reported mild, moderate, or severe financial toxicity, Margaret Liang, MD, of University of Alabama at Birmingham, said in presenting the findings.
Younger age and lower income were both risk factors for financial toxicity, and having insurance did not protect patients from financial toxicity. Dr. Liang noted that insurance coverage “was not protective for financial toxicity, as the majority of those who screened positive for financial toxicity were insured.” Specifically, 89% of patients with financial toxicity and 98% of patients without it were insured (P = .07).
“This finding supports financial toxicity screening regardless of insurance status and may favor universal screening,” Dr. Liang said.
She and her colleagues conducted the survey of 121 gynecologic cancer patients who had started a new line of systemic therapy in the previous 8 weeks.
The patients’ mean age was 59 years (range, 33-80), and 58% were starting their first line of systemic therapy. Half of the patients had a household income below $40,000, and about one-third of the patients were employed. Most had private (74%) or public (20%) insurance, and 7% of patients were uninsured.
To assess financial toxicity, the researchers used the Comprehensive Score for Financial Toxicity (COST). A score of less than 26 was used as a threshold of financial toxicity. The severity of financial toxicity was graded on a scale of 1 to 4, with a lower score indicating worse toxicity.
Patients were most concerned about having enough money to cover the cost of treatment. Patients reported the lowest mean score—0.97—in response to the statement, “I know that I have enough money in savings, retirement, or assets to cover the costs of my treatment.”
Patients were least concerned about losing their job or income. They reported the highest mean score—3.29—in response to the statement, “I am concerned about keeping my job and income, including working at home.” However, as Dr. Liang pointed out, only one-third of patients were employed at baseline.
In all, 54% of patients reported financial toxicity—37% mild, 16% moderate, and 1% severe.
Dr. Liang and her colleagues found that younger age and lower income were associated with an increased risk for financial toxicity. The mean age was 57 years in patients with financial toxicity and 62 years in patients without it (P = .02). Household incomes were below $40,000 in 63% of patients with financial toxicity and 34% of those without it (P less than .01).
The researchers also found that patients with financial toxicity were significantly more likely to say their cancer diagnosis resulted in lost wages, borrowed money, altered spending habits, the need to sacrifice other things, and not paying bills on time (P less than .01 for all).
On the other hand, patients with financial toxicity were not significantly more likely to become unemployed, file for bankruptcy, sell their house, or get a second job due to their cancer diagnosis.
However, it’s important to note that these data were collected within 8 weeks of patients starting their new line of therapy. The final survey results will include follow-up at 3 months and 6 months.
Dr. Liang said the fact that more than half of patients reported financial toxicity within 8 weeks of starting a new line of therapy suggests early interventions are needed to prevent or reduce financial toxicity. This may include counseling patients on anticipated costs of care, screening for financial toxicity, and linking patients to available financial resources.
Dr. Liang had no financial disclosures.
SOURCE: Liang M et al. SGO 2019. Abstract 8.
REPORTING FROM SGO 2019
Light physical activity lowers CVD risk in older women
Even light physical activity can significantly reduce the risks of acquiring coronary heart disease specifically and the broad range of cardiovascular diseases in older women, new data suggests.
A paper published in JAMA Network Open reported the outcome of a prospective cohort study in 5,861 women, with a mean age of 78.5 years, who wore accelerometers for 7 days to measure physical activity.
than those in the lowest quartile of activity, who engaged in less than 3.9 hours per day, after adjusting for factors such as comorbidities, lifestyle, and cardiovascular risk.
Similarly, those in the highest quartile had an 18% lower risk of cardiovascular disease than those in the lowest quartile, after adjusting for potential confounders.
Researchers saw a significant dose-dependent decrease in the risk for incident coronary heart disease and cardiovascular disease with increasing light physical activity, such that each 1-hour increment of activity was associated with a 20% decrease in coronary heart disease risk and 10% decrease in cardiovascular disease risk.
Andrea Z. LaCroix, PhD, from the University of California, San Diego, and her coauthors noted that physical activity guidelines for aerobic activity suggest 75 minutes of vigorous physical activity or 150 minutes of moderate activity each day, but only around 25% of U.S. women aged over 75 years are estimated to meet this requirement.
“These guidelines may have discouraged PA [physical activity] when perceived to be unattainable by large segments of the population,” they wrote.
While the majority of active time in older adults is spent doing light physical activity, little is known about the cardiovascular effects of participating in this level of activity. “A major barrier has been that self-reported questionnaires measuring leisure-time PA do not adequately capture light PA that is acquired throughout the day in activities of daily living,” they wrote.
The study also looked at the impact of moderate to vigorous physical activity, finding a significant 46% reduction between the highest to lowest quartiles of activity in coronary heart disease risk and a 31% reduction in cardiovascular disease risk.
Even after adjusting for the use of lipid-lowering medication, antihypertensive medication or healthy eating scores, the results remained unchanged. The researchers also saw no change when women with angina and heart failure at baseline were excluded or when they excluded cardiovascular events that occurred during the first 6 months of follow-up.
The study was supported by the National Heart, Lung, and Blood Institute; the National Institutes of Health; and the Department of Health & Human Services. Six authors reported receiving funding from the study supporters and other research institutions, and one reported membership on the advisory committee for physical activity guidelines. No other conflicts of interest were reported.
SOURCE: LaCroix AZ et al. JAMA Netw Open. 2019 Mar 15. doi: 10.1001/jamanetworkopen.2019.0419.
Older women do not get enough physical activity, so this finding that light physical activity is associated with improved coronary heart disease and cardiovascular disease outcomes supports the recent scientific report by the 2018 Physical Activity Guidelines Advisory Committee. It is also helpful in extending the evidence about the benefits of physical activity in reducing incident coronary heart disease to older women, as previous studies on this topic showed such benefits in men.
These findings should remind health care professionals, systems, and agencies to promote the 2018 Physical Activity Guidelines for Americans to all patients. Otherwise, the future health and well-being of older women is likely to suffer from the consequences of sedentary behavior and inadequate physical activity.
Gregory W. Heath, DHSc, MPH, is from the department of health and human performance at the University of Tennessee, Chattanooga. These comments are adapted from an accompanying editorial (JAMA Netw Open. 2019 Mar 15. doi: 10.1001/jamanetworkopen.2019.0405). No conflicts of interest were reported.
Older women do not get enough physical activity, so this finding that light physical activity is associated with improved coronary heart disease and cardiovascular disease outcomes supports the recent scientific report by the 2018 Physical Activity Guidelines Advisory Committee. It is also helpful in extending the evidence about the benefits of physical activity in reducing incident coronary heart disease to older women, as previous studies on this topic showed such benefits in men.
These findings should remind health care professionals, systems, and agencies to promote the 2018 Physical Activity Guidelines for Americans to all patients. Otherwise, the future health and well-being of older women is likely to suffer from the consequences of sedentary behavior and inadequate physical activity.
Gregory W. Heath, DHSc, MPH, is from the department of health and human performance at the University of Tennessee, Chattanooga. These comments are adapted from an accompanying editorial (JAMA Netw Open. 2019 Mar 15. doi: 10.1001/jamanetworkopen.2019.0405). No conflicts of interest were reported.
Older women do not get enough physical activity, so this finding that light physical activity is associated with improved coronary heart disease and cardiovascular disease outcomes supports the recent scientific report by the 2018 Physical Activity Guidelines Advisory Committee. It is also helpful in extending the evidence about the benefits of physical activity in reducing incident coronary heart disease to older women, as previous studies on this topic showed such benefits in men.
These findings should remind health care professionals, systems, and agencies to promote the 2018 Physical Activity Guidelines for Americans to all patients. Otherwise, the future health and well-being of older women is likely to suffer from the consequences of sedentary behavior and inadequate physical activity.
Gregory W. Heath, DHSc, MPH, is from the department of health and human performance at the University of Tennessee, Chattanooga. These comments are adapted from an accompanying editorial (JAMA Netw Open. 2019 Mar 15. doi: 10.1001/jamanetworkopen.2019.0405). No conflicts of interest were reported.
Even light physical activity can significantly reduce the risks of acquiring coronary heart disease specifically and the broad range of cardiovascular diseases in older women, new data suggests.
A paper published in JAMA Network Open reported the outcome of a prospective cohort study in 5,861 women, with a mean age of 78.5 years, who wore accelerometers for 7 days to measure physical activity.
than those in the lowest quartile of activity, who engaged in less than 3.9 hours per day, after adjusting for factors such as comorbidities, lifestyle, and cardiovascular risk.
Similarly, those in the highest quartile had an 18% lower risk of cardiovascular disease than those in the lowest quartile, after adjusting for potential confounders.
Researchers saw a significant dose-dependent decrease in the risk for incident coronary heart disease and cardiovascular disease with increasing light physical activity, such that each 1-hour increment of activity was associated with a 20% decrease in coronary heart disease risk and 10% decrease in cardiovascular disease risk.
Andrea Z. LaCroix, PhD, from the University of California, San Diego, and her coauthors noted that physical activity guidelines for aerobic activity suggest 75 minutes of vigorous physical activity or 150 minutes of moderate activity each day, but only around 25% of U.S. women aged over 75 years are estimated to meet this requirement.
“These guidelines may have discouraged PA [physical activity] when perceived to be unattainable by large segments of the population,” they wrote.
While the majority of active time in older adults is spent doing light physical activity, little is known about the cardiovascular effects of participating in this level of activity. “A major barrier has been that self-reported questionnaires measuring leisure-time PA do not adequately capture light PA that is acquired throughout the day in activities of daily living,” they wrote.
The study also looked at the impact of moderate to vigorous physical activity, finding a significant 46% reduction between the highest to lowest quartiles of activity in coronary heart disease risk and a 31% reduction in cardiovascular disease risk.
Even after adjusting for the use of lipid-lowering medication, antihypertensive medication or healthy eating scores, the results remained unchanged. The researchers also saw no change when women with angina and heart failure at baseline were excluded or when they excluded cardiovascular events that occurred during the first 6 months of follow-up.
The study was supported by the National Heart, Lung, and Blood Institute; the National Institutes of Health; and the Department of Health & Human Services. Six authors reported receiving funding from the study supporters and other research institutions, and one reported membership on the advisory committee for physical activity guidelines. No other conflicts of interest were reported.
SOURCE: LaCroix AZ et al. JAMA Netw Open. 2019 Mar 15. doi: 10.1001/jamanetworkopen.2019.0419.
Even light physical activity can significantly reduce the risks of acquiring coronary heart disease specifically and the broad range of cardiovascular diseases in older women, new data suggests.
A paper published in JAMA Network Open reported the outcome of a prospective cohort study in 5,861 women, with a mean age of 78.5 years, who wore accelerometers for 7 days to measure physical activity.
than those in the lowest quartile of activity, who engaged in less than 3.9 hours per day, after adjusting for factors such as comorbidities, lifestyle, and cardiovascular risk.
Similarly, those in the highest quartile had an 18% lower risk of cardiovascular disease than those in the lowest quartile, after adjusting for potential confounders.
Researchers saw a significant dose-dependent decrease in the risk for incident coronary heart disease and cardiovascular disease with increasing light physical activity, such that each 1-hour increment of activity was associated with a 20% decrease in coronary heart disease risk and 10% decrease in cardiovascular disease risk.
Andrea Z. LaCroix, PhD, from the University of California, San Diego, and her coauthors noted that physical activity guidelines for aerobic activity suggest 75 minutes of vigorous physical activity or 150 minutes of moderate activity each day, but only around 25% of U.S. women aged over 75 years are estimated to meet this requirement.
“These guidelines may have discouraged PA [physical activity] when perceived to be unattainable by large segments of the population,” they wrote.
While the majority of active time in older adults is spent doing light physical activity, little is known about the cardiovascular effects of participating in this level of activity. “A major barrier has been that self-reported questionnaires measuring leisure-time PA do not adequately capture light PA that is acquired throughout the day in activities of daily living,” they wrote.
The study also looked at the impact of moderate to vigorous physical activity, finding a significant 46% reduction between the highest to lowest quartiles of activity in coronary heart disease risk and a 31% reduction in cardiovascular disease risk.
Even after adjusting for the use of lipid-lowering medication, antihypertensive medication or healthy eating scores, the results remained unchanged. The researchers also saw no change when women with angina and heart failure at baseline were excluded or when they excluded cardiovascular events that occurred during the first 6 months of follow-up.
The study was supported by the National Heart, Lung, and Blood Institute; the National Institutes of Health; and the Department of Health & Human Services. Six authors reported receiving funding from the study supporters and other research institutions, and one reported membership on the advisory committee for physical activity guidelines. No other conflicts of interest were reported.
SOURCE: LaCroix AZ et al. JAMA Netw Open. 2019 Mar 15. doi: 10.1001/jamanetworkopen.2019.0419.
FROM JAMA NETWORK OPEN
‘The birth of a mother is a complex process’
Softening the blow to women and families of severe perinatal, postpartum psychiatric disorders
Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.
“But this was not what I expected!” That’s a statement I have heard from countless new mothers.
Women often envision pregnancy and the postpartum period as a time of pure joy. The glow of an expectant woman and the excitement of the arrival of a new baby masks the reality that many women struggle emotionally when transitioning to motherhood. Like the birth of a child, the birth of a mother is a complex process. Upholding the myth that all women seamlessly transform into mothers can have devastating effects and hinder access to mental health care.
As a psychiatrist working on a women’s inpatient unit with a perinatal program, I treat women at times of crisis. What may have begun as mild anxiety or depression sometimes quickly spirals into severe psychiatric illness. The sheer force of these severe perinatal and postpartum psychiatric disorders often leaves women and families shocked and confused, wondering what happened to their crumbled dreams of early motherhood.
What must general psychiatrists know about perinatal and postpartum psychiatric disorders? Why is maternal mental health so important? What are the barriers to treatment for these women? How can general psychiatrists best support and treat these new mothers and their families?
What data show
Maternal depression is now known to be one of the most common complications of pregnancy. Studies have suggested that about 11% of women experience depression during pregnancy1 and approximately 17% of women are depressed in the postpartum period.2 Perinatal generalized anxiety disorder has been shown to have a prevalence of 8.5%-10.5% during pregnancy with a wider variance post partum.3 Approximately 3% of women in the general community develop PTSD symptoms following childbirth.4 Research suggests that about 2% of women develop obsessive-compulsive disorder symptoms in the postpartum period.5 Postpartum psychosis, a rare but potentially devastating illness, occurs after 0.1%-0.2% of births.6
Importance of maternal mental health
There is a growing body of literature supporting both obstetric and pediatric adverse outcomes related to untreated psychiatric illness. Untreated maternal depression has been associated with obstetric complications, such as preterm delivery, preeclampsia, low birth weight, as well as the child’s developing cognitive function.7 Anxiety during pregnancy has been associated with both a shorter gestational period and adverse implications for fetal neurodevelopment.
These adverse effects were found to be even more potent in “pregnancy anxiety,” or anxiety specifically focused on the pregnancy, the birth experience, and the transition to motherhood.8 The psychotic symptoms occurring during postpartum psychosis can jeopardize the lives of both a woman and her child and carries a 4% risk of infanticide.9 Although there are limited data about the long-term effects of postpartum obsessive-compulsive disorders and PTSD, it is reasonable to assume that they might carry negative long-term implications for the mother and possibly her child.
Barriers to treatment
Despite the significant rates of mental illness, pregnant and new mothers often face barriers to receiving treatment. Many psychiatrists are hesitant to prescribe psychiatric medication to pregnant women because of concerns about teratogenic potential of psychiatric medications; similar concerns exist for newborn babies when prescribing medications to lactating mothers. In addition, the field of reproductive psychiatry is evolving at a rapid pace, making it difficult for busy psychiatrists to keep up with the ever-growing literature.
Also, it is hard to imagine a population that has more barriers to attending outpatient appointments. For many new mothers, the exhaustion and all-consuming work involved with taking care of a newborn are insurmountable barriers to obtaining mental health care. In addition, despite the awareness that new mothers often are more emotional, families can be slow to recognize the developing severity of a psychiatric illness during the peripartum and postpartum periods.
Supporting and treating new mothers
As general psychiatrists, there are several ways to directly help these women.
1. Expect the expected. Even in women with no prior psychiatric history, a significant percentage of expectant and postpartum women will develop acute psychiatric symptoms. Learn about the different presentations and treatments of perinatal and postpartum psychiatric disorders. For example, a woman might have thoughts of harming her baby in both postpartum psychosis and obsessive-compulsive disorder. However, the acuity and treatment of these two conditions drastically differ.
2. Learn more about psychiatric medications. Several apps and websites are available to psychiatrists to learn about the safety profile of psychiatric medications, such as Reprotox.org, mothertobaby.org, lactmed, and womensmentalhealth.org. Many medications are considered to be relatively safe during pregnancy and breastfeeding. It is important for psychiatrists to appreciate the risks when choosing not to prescribe to pregnant and postpartum women. Sometimes a known risk of a specific medication may be preferable to the unknown risk of leaving a woman susceptible to a severe psychiatric decompensation.
3. Involve all members of the family. A mother’s mental health has significant implications for the entire family. Psychoeducation for the family as well as frequent family sessions are key tools when treating this population. In addition, prescribing to pregnant women provides the opportunity for a psychiatrist to refine skills in joint decision making; it is crucial to involve both a patient and her spouse when discussing psychiatric medications.
4. Provide ready access and collaborate care. It is important to understand the potential rapid onset of psychiatric symptoms during the pregnancy and postpartum period. Psychiatrists should be prepared to collaborate care with other specialties. It is important to establish relationships with community psychotherapists specializing in maternal mental health, pediatricians, as well as obstetricians.
5. Learn when to seek a higher level of care. Although many women with perinatal and postpartum psychiatric symptoms can be managed as outpatients, women at times need a higher level of care. Similar to general psychiatry, women who are acutely suicidal or homicidal or have a sudden onset of psychotic and manic symptoms all should be evaluated immediately for inpatient hospitalization. Women with less severe symptoms but who require a higher level of care than typically offered in standard outpatient treatment should be candidates for partial hospitalization programs.
General intensive programs usually can accommodate these women, but it is ideal to refer this population to perinatal intensive programs. Postpartum Support International (postpartum.net) lists the nationwide inpatient and partial perinatal programs as well as regional and local services. An example of inpatient perinatal care is the women’s unit at Zucker Hillside Hospital (Northwell Health System, Glen Oaks, N.Y.), which houses an inpatient perinatal program. As a psychiatrist on the unit, I treat acute symptoms such as depression, anxiety, psychosis, mania, and catatonia that occur during the perinatal and postpartum periods. Given the severity of symptoms, I use a wide range of psychiatric medications with the possibility of electroconvulsive therapy when indicated. Psychotherapy staff on the unit offer specialized perinatal, mothers, and dialectical behavioral therapy groups. Breast pumps are available for women who wish to breastfeed. Accommodations are made for babies and children to visit their mother when clinically appropriate. Once discharged, women often are referred to Zucker Hillside’s own perinatal outpatient clinic for continued treatment. Similar models exist in select inpatient units as well as an increasing number of partial programs across the United States.
Conclusion
Psychiatric care for pregnant and new mothers can be challenging, but it is also immensely rewarding. Restoring a mother’s mental health usually leads to increased emotional stability for her entire family. Given the prevalence of maternal mental health disorders, psychiatrists in nearly every setting will encounter this population of women. With dedicated time devoted to reviewing the literature and learning about local resources, psychiatrists can feel comfortable treating women throughout the childbearing experience.
References
1. J Affect Disord. 2017 Sep;219:86-92.
2. J Psychiatr Res. 2018 Sep;104:235-48.
3. J Womens Health. (Larchmt). 2015 Sep;24(9):762-70.
4. Clin Psychol Rev. 2014 Jul;34(5):389-401.
5. Compr Psychiatry. 2009 Nov-Dec;50(6):503-9.
6. Int Rev Psychiatry. 2003 Aug;15(3):231-42.
7. Clin Obstet Gynecol. 2018 Sep;61(3):533-43.
8. Curr Opinion Psychiatry. 2012 Mar;25(2):141-8.
9. Am J Psychiatry. 2009 Apr;166(4):405-8.
Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine, New York, after graduating from the Albert Einstein College of Medicine and Yeshiva University, New York, with a BA in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.
Softening the blow to women and families of severe perinatal, postpartum psychiatric disorders
Softening the blow to women and families of severe perinatal, postpartum psychiatric disorders
Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.
“But this was not what I expected!” That’s a statement I have heard from countless new mothers.
Women often envision pregnancy and the postpartum period as a time of pure joy. The glow of an expectant woman and the excitement of the arrival of a new baby masks the reality that many women struggle emotionally when transitioning to motherhood. Like the birth of a child, the birth of a mother is a complex process. Upholding the myth that all women seamlessly transform into mothers can have devastating effects and hinder access to mental health care.
As a psychiatrist working on a women’s inpatient unit with a perinatal program, I treat women at times of crisis. What may have begun as mild anxiety or depression sometimes quickly spirals into severe psychiatric illness. The sheer force of these severe perinatal and postpartum psychiatric disorders often leaves women and families shocked and confused, wondering what happened to their crumbled dreams of early motherhood.
What must general psychiatrists know about perinatal and postpartum psychiatric disorders? Why is maternal mental health so important? What are the barriers to treatment for these women? How can general psychiatrists best support and treat these new mothers and their families?
What data show
Maternal depression is now known to be one of the most common complications of pregnancy. Studies have suggested that about 11% of women experience depression during pregnancy1 and approximately 17% of women are depressed in the postpartum period.2 Perinatal generalized anxiety disorder has been shown to have a prevalence of 8.5%-10.5% during pregnancy with a wider variance post partum.3 Approximately 3% of women in the general community develop PTSD symptoms following childbirth.4 Research suggests that about 2% of women develop obsessive-compulsive disorder symptoms in the postpartum period.5 Postpartum psychosis, a rare but potentially devastating illness, occurs after 0.1%-0.2% of births.6
Importance of maternal mental health
There is a growing body of literature supporting both obstetric and pediatric adverse outcomes related to untreated psychiatric illness. Untreated maternal depression has been associated with obstetric complications, such as preterm delivery, preeclampsia, low birth weight, as well as the child’s developing cognitive function.7 Anxiety during pregnancy has been associated with both a shorter gestational period and adverse implications for fetal neurodevelopment.
These adverse effects were found to be even more potent in “pregnancy anxiety,” or anxiety specifically focused on the pregnancy, the birth experience, and the transition to motherhood.8 The psychotic symptoms occurring during postpartum psychosis can jeopardize the lives of both a woman and her child and carries a 4% risk of infanticide.9 Although there are limited data about the long-term effects of postpartum obsessive-compulsive disorders and PTSD, it is reasonable to assume that they might carry negative long-term implications for the mother and possibly her child.
Barriers to treatment
Despite the significant rates of mental illness, pregnant and new mothers often face barriers to receiving treatment. Many psychiatrists are hesitant to prescribe psychiatric medication to pregnant women because of concerns about teratogenic potential of psychiatric medications; similar concerns exist for newborn babies when prescribing medications to lactating mothers. In addition, the field of reproductive psychiatry is evolving at a rapid pace, making it difficult for busy psychiatrists to keep up with the ever-growing literature.
Also, it is hard to imagine a population that has more barriers to attending outpatient appointments. For many new mothers, the exhaustion and all-consuming work involved with taking care of a newborn are insurmountable barriers to obtaining mental health care. In addition, despite the awareness that new mothers often are more emotional, families can be slow to recognize the developing severity of a psychiatric illness during the peripartum and postpartum periods.
Supporting and treating new mothers
As general psychiatrists, there are several ways to directly help these women.
1. Expect the expected. Even in women with no prior psychiatric history, a significant percentage of expectant and postpartum women will develop acute psychiatric symptoms. Learn about the different presentations and treatments of perinatal and postpartum psychiatric disorders. For example, a woman might have thoughts of harming her baby in both postpartum psychosis and obsessive-compulsive disorder. However, the acuity and treatment of these two conditions drastically differ.
2. Learn more about psychiatric medications. Several apps and websites are available to psychiatrists to learn about the safety profile of psychiatric medications, such as Reprotox.org, mothertobaby.org, lactmed, and womensmentalhealth.org. Many medications are considered to be relatively safe during pregnancy and breastfeeding. It is important for psychiatrists to appreciate the risks when choosing not to prescribe to pregnant and postpartum women. Sometimes a known risk of a specific medication may be preferable to the unknown risk of leaving a woman susceptible to a severe psychiatric decompensation.
3. Involve all members of the family. A mother’s mental health has significant implications for the entire family. Psychoeducation for the family as well as frequent family sessions are key tools when treating this population. In addition, prescribing to pregnant women provides the opportunity for a psychiatrist to refine skills in joint decision making; it is crucial to involve both a patient and her spouse when discussing psychiatric medications.
4. Provide ready access and collaborate care. It is important to understand the potential rapid onset of psychiatric symptoms during the pregnancy and postpartum period. Psychiatrists should be prepared to collaborate care with other specialties. It is important to establish relationships with community psychotherapists specializing in maternal mental health, pediatricians, as well as obstetricians.
5. Learn when to seek a higher level of care. Although many women with perinatal and postpartum psychiatric symptoms can be managed as outpatients, women at times need a higher level of care. Similar to general psychiatry, women who are acutely suicidal or homicidal or have a sudden onset of psychotic and manic symptoms all should be evaluated immediately for inpatient hospitalization. Women with less severe symptoms but who require a higher level of care than typically offered in standard outpatient treatment should be candidates for partial hospitalization programs.
General intensive programs usually can accommodate these women, but it is ideal to refer this population to perinatal intensive programs. Postpartum Support International (postpartum.net) lists the nationwide inpatient and partial perinatal programs as well as regional and local services. An example of inpatient perinatal care is the women’s unit at Zucker Hillside Hospital (Northwell Health System, Glen Oaks, N.Y.), which houses an inpatient perinatal program. As a psychiatrist on the unit, I treat acute symptoms such as depression, anxiety, psychosis, mania, and catatonia that occur during the perinatal and postpartum periods. Given the severity of symptoms, I use a wide range of psychiatric medications with the possibility of electroconvulsive therapy when indicated. Psychotherapy staff on the unit offer specialized perinatal, mothers, and dialectical behavioral therapy groups. Breast pumps are available for women who wish to breastfeed. Accommodations are made for babies and children to visit their mother when clinically appropriate. Once discharged, women often are referred to Zucker Hillside’s own perinatal outpatient clinic for continued treatment. Similar models exist in select inpatient units as well as an increasing number of partial programs across the United States.
Conclusion
Psychiatric care for pregnant and new mothers can be challenging, but it is also immensely rewarding. Restoring a mother’s mental health usually leads to increased emotional stability for her entire family. Given the prevalence of maternal mental health disorders, psychiatrists in nearly every setting will encounter this population of women. With dedicated time devoted to reviewing the literature and learning about local resources, psychiatrists can feel comfortable treating women throughout the childbearing experience.
References
1. J Affect Disord. 2017 Sep;219:86-92.
2. J Psychiatr Res. 2018 Sep;104:235-48.
3. J Womens Health. (Larchmt). 2015 Sep;24(9):762-70.
4. Clin Psychol Rev. 2014 Jul;34(5):389-401.
5. Compr Psychiatry. 2009 Nov-Dec;50(6):503-9.
6. Int Rev Psychiatry. 2003 Aug;15(3):231-42.
7. Clin Obstet Gynecol. 2018 Sep;61(3):533-43.
8. Curr Opinion Psychiatry. 2012 Mar;25(2):141-8.
9. Am J Psychiatry. 2009 Apr;166(4):405-8.
Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine, New York, after graduating from the Albert Einstein College of Medicine and Yeshiva University, New York, with a BA in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.
Editor’s Note: Alison M. Heru, MD, the Families in Psychiatry columnist, invited Dr. Reinstein to address this topic.
“But this was not what I expected!” That’s a statement I have heard from countless new mothers.
Women often envision pregnancy and the postpartum period as a time of pure joy. The glow of an expectant woman and the excitement of the arrival of a new baby masks the reality that many women struggle emotionally when transitioning to motherhood. Like the birth of a child, the birth of a mother is a complex process. Upholding the myth that all women seamlessly transform into mothers can have devastating effects and hinder access to mental health care.
As a psychiatrist working on a women’s inpatient unit with a perinatal program, I treat women at times of crisis. What may have begun as mild anxiety or depression sometimes quickly spirals into severe psychiatric illness. The sheer force of these severe perinatal and postpartum psychiatric disorders often leaves women and families shocked and confused, wondering what happened to their crumbled dreams of early motherhood.
What must general psychiatrists know about perinatal and postpartum psychiatric disorders? Why is maternal mental health so important? What are the barriers to treatment for these women? How can general psychiatrists best support and treat these new mothers and their families?
What data show
Maternal depression is now known to be one of the most common complications of pregnancy. Studies have suggested that about 11% of women experience depression during pregnancy1 and approximately 17% of women are depressed in the postpartum period.2 Perinatal generalized anxiety disorder has been shown to have a prevalence of 8.5%-10.5% during pregnancy with a wider variance post partum.3 Approximately 3% of women in the general community develop PTSD symptoms following childbirth.4 Research suggests that about 2% of women develop obsessive-compulsive disorder symptoms in the postpartum period.5 Postpartum psychosis, a rare but potentially devastating illness, occurs after 0.1%-0.2% of births.6
Importance of maternal mental health
There is a growing body of literature supporting both obstetric and pediatric adverse outcomes related to untreated psychiatric illness. Untreated maternal depression has been associated with obstetric complications, such as preterm delivery, preeclampsia, low birth weight, as well as the child’s developing cognitive function.7 Anxiety during pregnancy has been associated with both a shorter gestational period and adverse implications for fetal neurodevelopment.
These adverse effects were found to be even more potent in “pregnancy anxiety,” or anxiety specifically focused on the pregnancy, the birth experience, and the transition to motherhood.8 The psychotic symptoms occurring during postpartum psychosis can jeopardize the lives of both a woman and her child and carries a 4% risk of infanticide.9 Although there are limited data about the long-term effects of postpartum obsessive-compulsive disorders and PTSD, it is reasonable to assume that they might carry negative long-term implications for the mother and possibly her child.
Barriers to treatment
Despite the significant rates of mental illness, pregnant and new mothers often face barriers to receiving treatment. Many psychiatrists are hesitant to prescribe psychiatric medication to pregnant women because of concerns about teratogenic potential of psychiatric medications; similar concerns exist for newborn babies when prescribing medications to lactating mothers. In addition, the field of reproductive psychiatry is evolving at a rapid pace, making it difficult for busy psychiatrists to keep up with the ever-growing literature.
Also, it is hard to imagine a population that has more barriers to attending outpatient appointments. For many new mothers, the exhaustion and all-consuming work involved with taking care of a newborn are insurmountable barriers to obtaining mental health care. In addition, despite the awareness that new mothers often are more emotional, families can be slow to recognize the developing severity of a psychiatric illness during the peripartum and postpartum periods.
Supporting and treating new mothers
As general psychiatrists, there are several ways to directly help these women.
1. Expect the expected. Even in women with no prior psychiatric history, a significant percentage of expectant and postpartum women will develop acute psychiatric symptoms. Learn about the different presentations and treatments of perinatal and postpartum psychiatric disorders. For example, a woman might have thoughts of harming her baby in both postpartum psychosis and obsessive-compulsive disorder. However, the acuity and treatment of these two conditions drastically differ.
2. Learn more about psychiatric medications. Several apps and websites are available to psychiatrists to learn about the safety profile of psychiatric medications, such as Reprotox.org, mothertobaby.org, lactmed, and womensmentalhealth.org. Many medications are considered to be relatively safe during pregnancy and breastfeeding. It is important for psychiatrists to appreciate the risks when choosing not to prescribe to pregnant and postpartum women. Sometimes a known risk of a specific medication may be preferable to the unknown risk of leaving a woman susceptible to a severe psychiatric decompensation.
3. Involve all members of the family. A mother’s mental health has significant implications for the entire family. Psychoeducation for the family as well as frequent family sessions are key tools when treating this population. In addition, prescribing to pregnant women provides the opportunity for a psychiatrist to refine skills in joint decision making; it is crucial to involve both a patient and her spouse when discussing psychiatric medications.
4. Provide ready access and collaborate care. It is important to understand the potential rapid onset of psychiatric symptoms during the pregnancy and postpartum period. Psychiatrists should be prepared to collaborate care with other specialties. It is important to establish relationships with community psychotherapists specializing in maternal mental health, pediatricians, as well as obstetricians.
5. Learn when to seek a higher level of care. Although many women with perinatal and postpartum psychiatric symptoms can be managed as outpatients, women at times need a higher level of care. Similar to general psychiatry, women who are acutely suicidal or homicidal or have a sudden onset of psychotic and manic symptoms all should be evaluated immediately for inpatient hospitalization. Women with less severe symptoms but who require a higher level of care than typically offered in standard outpatient treatment should be candidates for partial hospitalization programs.
General intensive programs usually can accommodate these women, but it is ideal to refer this population to perinatal intensive programs. Postpartum Support International (postpartum.net) lists the nationwide inpatient and partial perinatal programs as well as regional and local services. An example of inpatient perinatal care is the women’s unit at Zucker Hillside Hospital (Northwell Health System, Glen Oaks, N.Y.), which houses an inpatient perinatal program. As a psychiatrist on the unit, I treat acute symptoms such as depression, anxiety, psychosis, mania, and catatonia that occur during the perinatal and postpartum periods. Given the severity of symptoms, I use a wide range of psychiatric medications with the possibility of electroconvulsive therapy when indicated. Psychotherapy staff on the unit offer specialized perinatal, mothers, and dialectical behavioral therapy groups. Breast pumps are available for women who wish to breastfeed. Accommodations are made for babies and children to visit their mother when clinically appropriate. Once discharged, women often are referred to Zucker Hillside’s own perinatal outpatient clinic for continued treatment. Similar models exist in select inpatient units as well as an increasing number of partial programs across the United States.
Conclusion
Psychiatric care for pregnant and new mothers can be challenging, but it is also immensely rewarding. Restoring a mother’s mental health usually leads to increased emotional stability for her entire family. Given the prevalence of maternal mental health disorders, psychiatrists in nearly every setting will encounter this population of women. With dedicated time devoted to reviewing the literature and learning about local resources, psychiatrists can feel comfortable treating women throughout the childbearing experience.
References
1. J Affect Disord. 2017 Sep;219:86-92.
2. J Psychiatr Res. 2018 Sep;104:235-48.
3. J Womens Health. (Larchmt). 2015 Sep;24(9):762-70.
4. Clin Psychol Rev. 2014 Jul;34(5):389-401.
5. Compr Psychiatry. 2009 Nov-Dec;50(6):503-9.
6. Int Rev Psychiatry. 2003 Aug;15(3):231-42.
7. Clin Obstet Gynecol. 2018 Sep;61(3):533-43.
8. Curr Opinion Psychiatry. 2012 Mar;25(2):141-8.
9. Am J Psychiatry. 2009 Apr;166(4):405-8.
Dr. Reinstein is a psychiatry attending at Zucker Hillside Hospital. Her clinical interests include reproductive psychiatry and family therapy, with a specific focus on maternal mental health. Dr. Reinstein completed her adult psychiatry residency training at Montefiore Hospital/Albert Einstein College of Medicine, New York, after graduating from the Albert Einstein College of Medicine and Yeshiva University, New York, with a BA in biology. She is one of the recipients of the 4th Annual Resident Recognition Award for Excellence in Family Oriented Care.
Survey of MS patients reveals numerous pregnancy-related concerns
DALLAS – When it comes to family planning and pregnancy-related decisions such as breastfeeding and medication management, patients with multiple sclerosis (MS) receive a wide variety of advice, guidance, and engagement from their health care providers, results from a single-center survey demonstrated.
“We want our patients to feel comfortable when they come to us in their 20s or 30s and they get diagnosed, they’re scared, and it’s all new to them,” one of the study authors, Casey E. Engel said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We want them to know that family planning is something to consider and that they can proceed with having a family with our help and guidance.”
In an effort to collect patient-experience data around family planning, pregnancy, and breastfeeding post-MS diagnosis, Ms. Engel and senior author Myla D. Goldman, MD, mailed a survey to 1,000 women with confirmed MS diagnosis who had received care at the University of Virginia Medical Center in Charlottesville. The researchers reported findings from 173 respondents, of whom 70% were receiving specialty care for MS. Most of the survey participants (137) did not become pregnant following their diagnosis, while 36 did.
Of the 137 respondents who did not become pregnant following diagnosis, 22 (16%) indicated that their decision was driven by MS-related concerns, including MS worsening with pregnancy (64%), ability to care for child secondary to MS (46%), lack of knowledge about options for pregnancy and MS (18%), passing MS onto child (18%), and stopping disease-modifying therapy (DMT) to attempt pregnancy (9%).
Of the 36 women who had a pregnancy following diagnosis, 20% reported postpartum depression or anxiety, higher than the national average of 10%-15%. In addition, 79% reported not being on DMT at the time of conception, 9% were on either glatiramer acetate injection or interferon beta-1a at time of conception, and 3% were on fingolimod (Gilenya) at time of conception. The majority reported receiving inconsistent advice about when to discontinue DMT before attempting pregnancy (a range from 0 to 6 months).
“It’s also noteworthy that 20% took a year to achieve pregnancy,” said Dr. Goldman, a neurologist who directs the university’s MS clinic. “If these women stop [their DMT] 6 months in advance and they take a year to achieve pregnancy, that’s 18 months without therapeutic coverage. That’s a concern to bring to light.”
Breastfeeding was reported in 71% of mothers in postdiagnosis pregnancy with a range between 1 week and 10 months, driven in part by variable guidelines regarding DMT reinitiation. In the meantime, respondents who did not breastfeed made this decision due to fear of relapse, glucocorticoids, or desire to reinitiate medication.
“Though our study was limited by low survey response, we hope that our work may highlight the difficulty our patients face and foster discussions within the MS community around these issues to improve the individual patient experience,” the researchers wrote in their poster.
Ms. Engel worked on the study while an undergraduate at the University of Virginia. The study was supported by the ziMS Foundation.
SOURCE: Engel CE et al. ACTRIMS Forum 2019, Poster 307.
DALLAS – When it comes to family planning and pregnancy-related decisions such as breastfeeding and medication management, patients with multiple sclerosis (MS) receive a wide variety of advice, guidance, and engagement from their health care providers, results from a single-center survey demonstrated.
“We want our patients to feel comfortable when they come to us in their 20s or 30s and they get diagnosed, they’re scared, and it’s all new to them,” one of the study authors, Casey E. Engel said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We want them to know that family planning is something to consider and that they can proceed with having a family with our help and guidance.”
In an effort to collect patient-experience data around family planning, pregnancy, and breastfeeding post-MS diagnosis, Ms. Engel and senior author Myla D. Goldman, MD, mailed a survey to 1,000 women with confirmed MS diagnosis who had received care at the University of Virginia Medical Center in Charlottesville. The researchers reported findings from 173 respondents, of whom 70% were receiving specialty care for MS. Most of the survey participants (137) did not become pregnant following their diagnosis, while 36 did.
Of the 137 respondents who did not become pregnant following diagnosis, 22 (16%) indicated that their decision was driven by MS-related concerns, including MS worsening with pregnancy (64%), ability to care for child secondary to MS (46%), lack of knowledge about options for pregnancy and MS (18%), passing MS onto child (18%), and stopping disease-modifying therapy (DMT) to attempt pregnancy (9%).
Of the 36 women who had a pregnancy following diagnosis, 20% reported postpartum depression or anxiety, higher than the national average of 10%-15%. In addition, 79% reported not being on DMT at the time of conception, 9% were on either glatiramer acetate injection or interferon beta-1a at time of conception, and 3% were on fingolimod (Gilenya) at time of conception. The majority reported receiving inconsistent advice about when to discontinue DMT before attempting pregnancy (a range from 0 to 6 months).
“It’s also noteworthy that 20% took a year to achieve pregnancy,” said Dr. Goldman, a neurologist who directs the university’s MS clinic. “If these women stop [their DMT] 6 months in advance and they take a year to achieve pregnancy, that’s 18 months without therapeutic coverage. That’s a concern to bring to light.”
Breastfeeding was reported in 71% of mothers in postdiagnosis pregnancy with a range between 1 week and 10 months, driven in part by variable guidelines regarding DMT reinitiation. In the meantime, respondents who did not breastfeed made this decision due to fear of relapse, glucocorticoids, or desire to reinitiate medication.
“Though our study was limited by low survey response, we hope that our work may highlight the difficulty our patients face and foster discussions within the MS community around these issues to improve the individual patient experience,” the researchers wrote in their poster.
Ms. Engel worked on the study while an undergraduate at the University of Virginia. The study was supported by the ziMS Foundation.
SOURCE: Engel CE et al. ACTRIMS Forum 2019, Poster 307.
DALLAS – When it comes to family planning and pregnancy-related decisions such as breastfeeding and medication management, patients with multiple sclerosis (MS) receive a wide variety of advice, guidance, and engagement from their health care providers, results from a single-center survey demonstrated.
“We want our patients to feel comfortable when they come to us in their 20s or 30s and they get diagnosed, they’re scared, and it’s all new to them,” one of the study authors, Casey E. Engel said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “We want them to know that family planning is something to consider and that they can proceed with having a family with our help and guidance.”
In an effort to collect patient-experience data around family planning, pregnancy, and breastfeeding post-MS diagnosis, Ms. Engel and senior author Myla D. Goldman, MD, mailed a survey to 1,000 women with confirmed MS diagnosis who had received care at the University of Virginia Medical Center in Charlottesville. The researchers reported findings from 173 respondents, of whom 70% were receiving specialty care for MS. Most of the survey participants (137) did not become pregnant following their diagnosis, while 36 did.
Of the 137 respondents who did not become pregnant following diagnosis, 22 (16%) indicated that their decision was driven by MS-related concerns, including MS worsening with pregnancy (64%), ability to care for child secondary to MS (46%), lack of knowledge about options for pregnancy and MS (18%), passing MS onto child (18%), and stopping disease-modifying therapy (DMT) to attempt pregnancy (9%).
Of the 36 women who had a pregnancy following diagnosis, 20% reported postpartum depression or anxiety, higher than the national average of 10%-15%. In addition, 79% reported not being on DMT at the time of conception, 9% were on either glatiramer acetate injection or interferon beta-1a at time of conception, and 3% were on fingolimod (Gilenya) at time of conception. The majority reported receiving inconsistent advice about when to discontinue DMT before attempting pregnancy (a range from 0 to 6 months).
“It’s also noteworthy that 20% took a year to achieve pregnancy,” said Dr. Goldman, a neurologist who directs the university’s MS clinic. “If these women stop [their DMT] 6 months in advance and they take a year to achieve pregnancy, that’s 18 months without therapeutic coverage. That’s a concern to bring to light.”
Breastfeeding was reported in 71% of mothers in postdiagnosis pregnancy with a range between 1 week and 10 months, driven in part by variable guidelines regarding DMT reinitiation. In the meantime, respondents who did not breastfeed made this decision due to fear of relapse, glucocorticoids, or desire to reinitiate medication.
“Though our study was limited by low survey response, we hope that our work may highlight the difficulty our patients face and foster discussions within the MS community around these issues to improve the individual patient experience,” the researchers wrote in their poster.
Ms. Engel worked on the study while an undergraduate at the University of Virginia. The study was supported by the ziMS Foundation.
SOURCE: Engel CE et al. ACTRIMS Forum 2019, Poster 307.
REPORTING FROM ACTRIMS FORUM 2019
Teriflunomide transmission can occur in female partners of men taking the drug
DALLAS – Low or undetectable levels of teriflunomide (Aubagio) occur in women who are sexually active with men taking the drug for relapsing multiple sclerosis, results from a small study demonstrated.
“One of the issues with this particular drug is that it carries a strong pregnancy warning because in animal studies the drug has been teratogenic,” Joseph B. Guarnaccia, MD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other issue is that it remains detectable in the body for some time. The issue of females taking this drug and conception are well known. There are strong warnings that, if a woman wants to become pregnant, the drug should be removed quickly from the system. But if their male partner is on the drug, does that pose a risk to their female partner? That question has never been addressed in a human study.”
The Food and Drug Administration prescribing information recommends that men wishing to father a child should discontinue use of teriflunomide and undergo the accelerated elimination procedure. It also recommends that female partners wishing to become pregnant should discontinue the drug and undergo an accelerated elimination procedure to verify that the plasma teriflunomide concentration is less than 0.020 mcg/mL.
In an effort to test the risk of female exposure to potentially teratogenic levels of teriflunomide through sexual intercourse, Dr. Guarnaccia, a neurologist with the Multiple Sclerosis Treatment Center at Griffin Hospital in Derby, Conn., and his colleagues recruited 10 couples and compared serum levels of teriflunomide in men with relapsing multiple sclerosis with those of their female partners. Enrollment criteria for men included a diagnosis of relapsing multiple sclerosis, age between 18 and 55 years, treatment with teriflunomide for at least 2 months prior to study entry, and frequency of sexual intercourse with their female partners at least twice a month. Pregnancy was excluded in females, and couples could not use barrier or withdrawal methods of contraception. The couples completed a brief questionnaire and underwent a one-time blood draw for teriflunomide levels either at the investigator’s office or at a LabCorp facility.
The mean age of study participants was 47 years and the mean frequency of intercourse was seven episodes per month. The mean teriflunomide concentration in men was 42.30 mcg/mL (ranged from 10.07 to 142.84 mcg/mL). Six women had teriflunomide below detection levels (0.020 mcg/mL). However, four women had detectable levels that averaged 0.045 mcg/mL (ranging from 0.022 to 0.077 mcg/mL).
“This small study demonstrates that low or undetectable levels of teriflunomide occur in females who are sexually active with males taking teriflunomide for relapsing multiple sclerosis,” the researchers wrote in their poster. They found that women who had low detectable levels of teriflunomide, compared with women with undetectable levels, did not engage in more frequent sexual intercourse nor were their levels associated with higher levels of teriflunomide in their male partners.
“Indeed, one might have expected a positive correlation between serum levels of teriflunomide in females and the frequency or concentration of inoculation in semen from their partners,” the researchers wrote. “While semen levels of teriflunomide were not measured in this study, it might be assumed that serum and semen concentrations of small molecules like teriflunomide are similar.”
The study was supported by a investigator-sponsored research grant from Sanofi-Genzyme. Dr. Guarnaccia reported that he has received speaking honoraria and educational grants from Sanofi-Genzyme, Biogen, Teva, Acorda Therapeutics, Bayer, EMD Serono, and Genentech.
SOURCE: Guarnaccia JB et al. ACTRIMS Forum 2019, Poster 115.
DALLAS – Low or undetectable levels of teriflunomide (Aubagio) occur in women who are sexually active with men taking the drug for relapsing multiple sclerosis, results from a small study demonstrated.
“One of the issues with this particular drug is that it carries a strong pregnancy warning because in animal studies the drug has been teratogenic,” Joseph B. Guarnaccia, MD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other issue is that it remains detectable in the body for some time. The issue of females taking this drug and conception are well known. There are strong warnings that, if a woman wants to become pregnant, the drug should be removed quickly from the system. But if their male partner is on the drug, does that pose a risk to their female partner? That question has never been addressed in a human study.”
The Food and Drug Administration prescribing information recommends that men wishing to father a child should discontinue use of teriflunomide and undergo the accelerated elimination procedure. It also recommends that female partners wishing to become pregnant should discontinue the drug and undergo an accelerated elimination procedure to verify that the plasma teriflunomide concentration is less than 0.020 mcg/mL.
In an effort to test the risk of female exposure to potentially teratogenic levels of teriflunomide through sexual intercourse, Dr. Guarnaccia, a neurologist with the Multiple Sclerosis Treatment Center at Griffin Hospital in Derby, Conn., and his colleagues recruited 10 couples and compared serum levels of teriflunomide in men with relapsing multiple sclerosis with those of their female partners. Enrollment criteria for men included a diagnosis of relapsing multiple sclerosis, age between 18 and 55 years, treatment with teriflunomide for at least 2 months prior to study entry, and frequency of sexual intercourse with their female partners at least twice a month. Pregnancy was excluded in females, and couples could not use barrier or withdrawal methods of contraception. The couples completed a brief questionnaire and underwent a one-time blood draw for teriflunomide levels either at the investigator’s office or at a LabCorp facility.
The mean age of study participants was 47 years and the mean frequency of intercourse was seven episodes per month. The mean teriflunomide concentration in men was 42.30 mcg/mL (ranged from 10.07 to 142.84 mcg/mL). Six women had teriflunomide below detection levels (0.020 mcg/mL). However, four women had detectable levels that averaged 0.045 mcg/mL (ranging from 0.022 to 0.077 mcg/mL).
“This small study demonstrates that low or undetectable levels of teriflunomide occur in females who are sexually active with males taking teriflunomide for relapsing multiple sclerosis,” the researchers wrote in their poster. They found that women who had low detectable levels of teriflunomide, compared with women with undetectable levels, did not engage in more frequent sexual intercourse nor were their levels associated with higher levels of teriflunomide in their male partners.
“Indeed, one might have expected a positive correlation between serum levels of teriflunomide in females and the frequency or concentration of inoculation in semen from their partners,” the researchers wrote. “While semen levels of teriflunomide were not measured in this study, it might be assumed that serum and semen concentrations of small molecules like teriflunomide are similar.”
The study was supported by a investigator-sponsored research grant from Sanofi-Genzyme. Dr. Guarnaccia reported that he has received speaking honoraria and educational grants from Sanofi-Genzyme, Biogen, Teva, Acorda Therapeutics, Bayer, EMD Serono, and Genentech.
SOURCE: Guarnaccia JB et al. ACTRIMS Forum 2019, Poster 115.
DALLAS – Low or undetectable levels of teriflunomide (Aubagio) occur in women who are sexually active with men taking the drug for relapsing multiple sclerosis, results from a small study demonstrated.
“One of the issues with this particular drug is that it carries a strong pregnancy warning because in animal studies the drug has been teratogenic,” Joseph B. Guarnaccia, MD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other issue is that it remains detectable in the body for some time. The issue of females taking this drug and conception are well known. There are strong warnings that, if a woman wants to become pregnant, the drug should be removed quickly from the system. But if their male partner is on the drug, does that pose a risk to their female partner? That question has never been addressed in a human study.”
The Food and Drug Administration prescribing information recommends that men wishing to father a child should discontinue use of teriflunomide and undergo the accelerated elimination procedure. It also recommends that female partners wishing to become pregnant should discontinue the drug and undergo an accelerated elimination procedure to verify that the plasma teriflunomide concentration is less than 0.020 mcg/mL.
In an effort to test the risk of female exposure to potentially teratogenic levels of teriflunomide through sexual intercourse, Dr. Guarnaccia, a neurologist with the Multiple Sclerosis Treatment Center at Griffin Hospital in Derby, Conn., and his colleagues recruited 10 couples and compared serum levels of teriflunomide in men with relapsing multiple sclerosis with those of their female partners. Enrollment criteria for men included a diagnosis of relapsing multiple sclerosis, age between 18 and 55 years, treatment with teriflunomide for at least 2 months prior to study entry, and frequency of sexual intercourse with their female partners at least twice a month. Pregnancy was excluded in females, and couples could not use barrier or withdrawal methods of contraception. The couples completed a brief questionnaire and underwent a one-time blood draw for teriflunomide levels either at the investigator’s office or at a LabCorp facility.
The mean age of study participants was 47 years and the mean frequency of intercourse was seven episodes per month. The mean teriflunomide concentration in men was 42.30 mcg/mL (ranged from 10.07 to 142.84 mcg/mL). Six women had teriflunomide below detection levels (0.020 mcg/mL). However, four women had detectable levels that averaged 0.045 mcg/mL (ranging from 0.022 to 0.077 mcg/mL).
“This small study demonstrates that low or undetectable levels of teriflunomide occur in females who are sexually active with males taking teriflunomide for relapsing multiple sclerosis,” the researchers wrote in their poster. They found that women who had low detectable levels of teriflunomide, compared with women with undetectable levels, did not engage in more frequent sexual intercourse nor were their levels associated with higher levels of teriflunomide in their male partners.
“Indeed, one might have expected a positive correlation between serum levels of teriflunomide in females and the frequency or concentration of inoculation in semen from their partners,” the researchers wrote. “While semen levels of teriflunomide were not measured in this study, it might be assumed that serum and semen concentrations of small molecules like teriflunomide are similar.”
The study was supported by a investigator-sponsored research grant from Sanofi-Genzyme. Dr. Guarnaccia reported that he has received speaking honoraria and educational grants from Sanofi-Genzyme, Biogen, Teva, Acorda Therapeutics, Bayer, EMD Serono, and Genentech.
SOURCE: Guarnaccia JB et al. ACTRIMS Forum 2019, Poster 115.
REPORTING FROM ACTRIMS FORUM 2019
Tight intrapartum glucose control doesn’t improve neonatal outcomes
LAS VEGAS – There was no difference in first neonatal glucose level or glucose levels within the first 24 hours of life when women with gestational diabetes received strict, rather than liberalized, glucose management in labor.
In a study of 76 women with gestational diabetes mellitus (GDM), the mean first blood glucose level was 53 mg/dL for neonates born to the 38 mothers who received tight glucose control during labor; for those born to the 38 women who received liberalized control, mean first glucose level was 56 mg/dL (interquartile ranges, 22-85 mg/dL and 27-126 mg/dL, respectively; P = .56).
Secondary outcomes tracked in the study included the proportion of neonates whose glucose levels were low (defined as less than 40 mg/dL) at birth. This figure was identical in both groups, at 24%.
These findings ran counter to the hypothesis that Maureen Hamel, MD, and her colleagues at Brown University, Providence, R.I., had formulated – that neonates whose mothers had tight intrapartum glucose control would have lower rates of neonatal hypoglycemia than those born to women with liberalized intrapartum control.
Although the differences did not reach statistical significance, numerically more infants in the tight-control group required any intervention for hypoglycemia (45% vs. 32%; P = .35) or intravenous intervention for hypoglycemia (11% vs 0%; P = .35). Neonatal ICU admission was required for 13% of the tight-control neonates versus 3% of the liberalized-control group (P = .20).
“A protocol aimed at tight maternal glucose management in labor, compared to liberalized management, for women with GDM, did not result in a lower rate of neonatal hypoglycemia and was associated with mean neonatal glucose closer to hypoglycemia [40 mg/dL] in the first 24 hours of life,” said Dr. Hamel, discussing the findings of her award-winning abstract at the meeting presented by the Society for Maternal-Fetal Medicine.
Women were included if they were at least 18 years old with a singleton pregnancy and a diagnosis of gestational diabetes. Participants received care through a specialized program for pregnant women with diabetes; they were considered to have GDM if they had at least two abnormal values from a 100-g, 3-hour glucose tolerance test (GTT) or had a blood glucose reading of at least 200 mg/dL from a 1-hour 50-g GTT. About two-thirds of women required medical management of GDM; about 80% received labor induction at 39 weeks’ gestation.
At 36 weeks’ gestation, participants were block-randomized 1:1 to receive tight or liberalized intrapartum blood glucose control, with allocation unknown to both providers and patients until participants were admitted for delivery. Neonatal providers were blinded as to allocation throughout the admission. “In the tight glucose control group, point-of-care glucose was assessed hourly,” said Dr. Hamel. “Goal glucose levels were 70-100 [mg/dL], and treatment was initiated for a single maternal glucose greater than 100 and less than 60 [mg/dL].”
Those in the liberalized group had blood sugar checked every 4 hours in the absence of symptoms, with a goal blood glucose range of 70-120 mg/dL and treatment initiated for blood glucose over 120 or less than 60 mg/dL.
The increase in older women giving birth partly underlies the increase in GDM, said Dr. Hamel. By 35 years of age, about 15% of women will develop GDM, compared with under 6% for women giving birth between 20 and 24 years of age.
Neonatal hypoglycemia, with associated risks for neonatal ICU admission, seizures, and neurologic injury, is more common in women with GDM, said Dr. Hamel, a maternal-fetal medicine fellow.
There’s wide institutional and geographic variation in intrapartum maternal glucose management, said Dr. Hamel. Even within her own institution, blood sugar might be checked just once in labor, every 2 hours, or every hour, and the threshold for treatment might be set at a maternal blood glucose level over 100, 120, or even 200 mg/dL.
The study benefited from the fact that there was standardized antepartum GDM management in place and that 100% of outcome data were available. Also, the a priori sample size to detect significant between-group differences was obtained, and neonatal providers were blinded as to maternal glucose control strategy. Replication of the study should be both easy and feasible, said Dr. Hamel.
However, only very short-term outcomes were tracked, and the study was not powered to detect differences in such less-frequent neonatal outcomes as neonatal ICU admission.
“There is no benefit to tight maternal glucose control in labor among women with GDM,” concluded Dr. Hamel. “Our findings support glucose assessment every 4 hours, with intervention for blood glucose levels less than 60 or higher than 120 [mg/dL].”
Dr. Hamel reported no outside sources of funding and no conflicts of interest.
SOURCE: Hamel M et al. Am J Obstet Gynecol. 2019 Jan. 220;1:S36, Abstract 44.
LAS VEGAS – There was no difference in first neonatal glucose level or glucose levels within the first 24 hours of life when women with gestational diabetes received strict, rather than liberalized, glucose management in labor.
In a study of 76 women with gestational diabetes mellitus (GDM), the mean first blood glucose level was 53 mg/dL for neonates born to the 38 mothers who received tight glucose control during labor; for those born to the 38 women who received liberalized control, mean first glucose level was 56 mg/dL (interquartile ranges, 22-85 mg/dL and 27-126 mg/dL, respectively; P = .56).
Secondary outcomes tracked in the study included the proportion of neonates whose glucose levels were low (defined as less than 40 mg/dL) at birth. This figure was identical in both groups, at 24%.
These findings ran counter to the hypothesis that Maureen Hamel, MD, and her colleagues at Brown University, Providence, R.I., had formulated – that neonates whose mothers had tight intrapartum glucose control would have lower rates of neonatal hypoglycemia than those born to women with liberalized intrapartum control.
Although the differences did not reach statistical significance, numerically more infants in the tight-control group required any intervention for hypoglycemia (45% vs. 32%; P = .35) or intravenous intervention for hypoglycemia (11% vs 0%; P = .35). Neonatal ICU admission was required for 13% of the tight-control neonates versus 3% of the liberalized-control group (P = .20).
“A protocol aimed at tight maternal glucose management in labor, compared to liberalized management, for women with GDM, did not result in a lower rate of neonatal hypoglycemia and was associated with mean neonatal glucose closer to hypoglycemia [40 mg/dL] in the first 24 hours of life,” said Dr. Hamel, discussing the findings of her award-winning abstract at the meeting presented by the Society for Maternal-Fetal Medicine.
Women were included if they were at least 18 years old with a singleton pregnancy and a diagnosis of gestational diabetes. Participants received care through a specialized program for pregnant women with diabetes; they were considered to have GDM if they had at least two abnormal values from a 100-g, 3-hour glucose tolerance test (GTT) or had a blood glucose reading of at least 200 mg/dL from a 1-hour 50-g GTT. About two-thirds of women required medical management of GDM; about 80% received labor induction at 39 weeks’ gestation.
At 36 weeks’ gestation, participants were block-randomized 1:1 to receive tight or liberalized intrapartum blood glucose control, with allocation unknown to both providers and patients until participants were admitted for delivery. Neonatal providers were blinded as to allocation throughout the admission. “In the tight glucose control group, point-of-care glucose was assessed hourly,” said Dr. Hamel. “Goal glucose levels were 70-100 [mg/dL], and treatment was initiated for a single maternal glucose greater than 100 and less than 60 [mg/dL].”
Those in the liberalized group had blood sugar checked every 4 hours in the absence of symptoms, with a goal blood glucose range of 70-120 mg/dL and treatment initiated for blood glucose over 120 or less than 60 mg/dL.
The increase in older women giving birth partly underlies the increase in GDM, said Dr. Hamel. By 35 years of age, about 15% of women will develop GDM, compared with under 6% for women giving birth between 20 and 24 years of age.
Neonatal hypoglycemia, with associated risks for neonatal ICU admission, seizures, and neurologic injury, is more common in women with GDM, said Dr. Hamel, a maternal-fetal medicine fellow.
There’s wide institutional and geographic variation in intrapartum maternal glucose management, said Dr. Hamel. Even within her own institution, blood sugar might be checked just once in labor, every 2 hours, or every hour, and the threshold for treatment might be set at a maternal blood glucose level over 100, 120, or even 200 mg/dL.
The study benefited from the fact that there was standardized antepartum GDM management in place and that 100% of outcome data were available. Also, the a priori sample size to detect significant between-group differences was obtained, and neonatal providers were blinded as to maternal glucose control strategy. Replication of the study should be both easy and feasible, said Dr. Hamel.
However, only very short-term outcomes were tracked, and the study was not powered to detect differences in such less-frequent neonatal outcomes as neonatal ICU admission.
“There is no benefit to tight maternal glucose control in labor among women with GDM,” concluded Dr. Hamel. “Our findings support glucose assessment every 4 hours, with intervention for blood glucose levels less than 60 or higher than 120 [mg/dL].”
Dr. Hamel reported no outside sources of funding and no conflicts of interest.
SOURCE: Hamel M et al. Am J Obstet Gynecol. 2019 Jan. 220;1:S36, Abstract 44.
LAS VEGAS – There was no difference in first neonatal glucose level or glucose levels within the first 24 hours of life when women with gestational diabetes received strict, rather than liberalized, glucose management in labor.
In a study of 76 women with gestational diabetes mellitus (GDM), the mean first blood glucose level was 53 mg/dL for neonates born to the 38 mothers who received tight glucose control during labor; for those born to the 38 women who received liberalized control, mean first glucose level was 56 mg/dL (interquartile ranges, 22-85 mg/dL and 27-126 mg/dL, respectively; P = .56).
Secondary outcomes tracked in the study included the proportion of neonates whose glucose levels were low (defined as less than 40 mg/dL) at birth. This figure was identical in both groups, at 24%.
These findings ran counter to the hypothesis that Maureen Hamel, MD, and her colleagues at Brown University, Providence, R.I., had formulated – that neonates whose mothers had tight intrapartum glucose control would have lower rates of neonatal hypoglycemia than those born to women with liberalized intrapartum control.
Although the differences did not reach statistical significance, numerically more infants in the tight-control group required any intervention for hypoglycemia (45% vs. 32%; P = .35) or intravenous intervention for hypoglycemia (11% vs 0%; P = .35). Neonatal ICU admission was required for 13% of the tight-control neonates versus 3% of the liberalized-control group (P = .20).
“A protocol aimed at tight maternal glucose management in labor, compared to liberalized management, for women with GDM, did not result in a lower rate of neonatal hypoglycemia and was associated with mean neonatal glucose closer to hypoglycemia [40 mg/dL] in the first 24 hours of life,” said Dr. Hamel, discussing the findings of her award-winning abstract at the meeting presented by the Society for Maternal-Fetal Medicine.
Women were included if they were at least 18 years old with a singleton pregnancy and a diagnosis of gestational diabetes. Participants received care through a specialized program for pregnant women with diabetes; they were considered to have GDM if they had at least two abnormal values from a 100-g, 3-hour glucose tolerance test (GTT) or had a blood glucose reading of at least 200 mg/dL from a 1-hour 50-g GTT. About two-thirds of women required medical management of GDM; about 80% received labor induction at 39 weeks’ gestation.
At 36 weeks’ gestation, participants were block-randomized 1:1 to receive tight or liberalized intrapartum blood glucose control, with allocation unknown to both providers and patients until participants were admitted for delivery. Neonatal providers were blinded as to allocation throughout the admission. “In the tight glucose control group, point-of-care glucose was assessed hourly,” said Dr. Hamel. “Goal glucose levels were 70-100 [mg/dL], and treatment was initiated for a single maternal glucose greater than 100 and less than 60 [mg/dL].”
Those in the liberalized group had blood sugar checked every 4 hours in the absence of symptoms, with a goal blood glucose range of 70-120 mg/dL and treatment initiated for blood glucose over 120 or less than 60 mg/dL.
The increase in older women giving birth partly underlies the increase in GDM, said Dr. Hamel. By 35 years of age, about 15% of women will develop GDM, compared with under 6% for women giving birth between 20 and 24 years of age.
Neonatal hypoglycemia, with associated risks for neonatal ICU admission, seizures, and neurologic injury, is more common in women with GDM, said Dr. Hamel, a maternal-fetal medicine fellow.
There’s wide institutional and geographic variation in intrapartum maternal glucose management, said Dr. Hamel. Even within her own institution, blood sugar might be checked just once in labor, every 2 hours, or every hour, and the threshold for treatment might be set at a maternal blood glucose level over 100, 120, or even 200 mg/dL.
The study benefited from the fact that there was standardized antepartum GDM management in place and that 100% of outcome data were available. Also, the a priori sample size to detect significant between-group differences was obtained, and neonatal providers were blinded as to maternal glucose control strategy. Replication of the study should be both easy and feasible, said Dr. Hamel.
However, only very short-term outcomes were tracked, and the study was not powered to detect differences in such less-frequent neonatal outcomes as neonatal ICU admission.
“There is no benefit to tight maternal glucose control in labor among women with GDM,” concluded Dr. Hamel. “Our findings support glucose assessment every 4 hours, with intervention for blood glucose levels less than 60 or higher than 120 [mg/dL].”
Dr. Hamel reported no outside sources of funding and no conflicts of interest.
SOURCE: Hamel M et al. Am J Obstet Gynecol. 2019 Jan. 220;1:S36, Abstract 44.
REPORTING FROM THE PREGNANCY MEETING
Prenatal betamethasone not linked to later adverse neurocognitive problems
Administering prenatal corticosteroids to women at risk for preterm birth does not appear to contribute to adverse neurocognitive function in children 6-8 years later, regardless of whether they had fetal growth restriction, a new study found.
Women at less than 32 weeks’ gestation are recommended to receive multiple betamethasone doses if they have a high ongoing risk of preterm birth. However, concern existed regarding possible effects of these steroid doses on the infant in later childhood, particularly in cases of fetal growth restriction (FGR) because of “animal studies suggesting long-term adverse effects of treatment on neurosensory function,” Robert D. Cartwright of the University of Auckland (New Zealand), and his associates reported in JAMA Network Open.
Yet no such effects were identified in this preplanned follow-up analysis of the placebo-controlled, randomized Australasian Collaborative Trial of Repeat Doses of Corticosteroids (ACTORDS). “Physicians should use repeated doses of antenatal corticosteroids when indicated before preterm birth, regardless of fetal growth restriction, in view of the associated neonatal benefits and absence of later adverse effects,” the authors concluded.
The original ACTORDS study involved 982 women pregnant with 1,146 fetuses at 23 hospitals throughout Australia and New Zealand, enrolled from April 1998 to July 2004. All enrolled women were less than 32 weeks’ gestation, had received an initial course of corticosteroids, and had an ongoing risk of preterm birth at least 7 days later.
Women were randomly assigned to receive an intramuscular dose of betamethasone or saline placebo weekly until birth or preterm birth risk abated. The current follow-up, when children were 6-8 years old, was planned during the 2-year follow-up. Children underwent a pediatrician’s physical and neurologic exam, vision and hearing screening, and fine and gross motor testing. A psychologist tested children’s IQ, attention, executive function, and academic skills using standardized, validated assessment tools. Caregivers also rated children’s behavioral and emotional problems, executive function abilities, and attention in questionnaires.
Among 988 of 1,059 surviving children assessed, FGR occurred in 28% of children exposed to betamethasone and 25% in the placebo group.
For the primary outcomes, rates of disability-free survival were similar in both the placebo and betamethasone groups for children with (odds ratio, 1.1) and without FGR (OR, 1.0). Rates also were similar for death or survival with moderate to severe disability (FGR: OR, 0.9; and non-FGR: OR, 0.8).
“Some evidence suggested a differential effect for several secondary outcomes, with better scores for selective and divided attention after exposure to repeated antenatal betamethasone in children with FGR, but poorer scores for impulse control in children without FGR,” Dr. Cartwright and his associates reported. “These effects were small and of uncertain clinical significance and may reflect type I error.
“For all other measures of neurocognitive function and learning, exposure to repeated antenatal betamethasone treatment did not alter performance in midchildhood, even in the presence of FGR,” they added.
Children with FGR had an increased risk of death or moderate to severe disability, compared with children without FGR, regardless of treatment group. Those with FGR also had greater risk of motor impairment.
One possible reason for not finding adverse neurocognitive effects in the betamethasone group is “that infants with fetal growth restriction appeared to have greater benefit from repeated antenatal corticosteroid therapy, with a nearly twofold reduction in serious neonatal morbidity,” the authors surmised. “Thus, the decrease in serious postnatal complications may have counteracted any potential adverse effects of corticosteroid exposure.” But they noted a continuing concern about whether “repeated antenatal corticosteroids in FGR could increase the risk of ADHD.”
The research was funded by the National Health Medical Research Council of Australia, the Health Research Council of New Zealand and the Auckland Medical Research Foundation. One coauthor reported receiving grants from National Health and Medical Research Council of Australia, and a second coauthor received grants from the Auckland Medical Research Foundation.
SOURCE: Cartwright RD et al. JAMA Netw Open. 2019 Feb 1. doi:10.1001/jamanetworkopen.2018.7636.
Administering prenatal corticosteroids to women at risk for preterm birth does not appear to contribute to adverse neurocognitive function in children 6-8 years later, regardless of whether they had fetal growth restriction, a new study found.
Women at less than 32 weeks’ gestation are recommended to receive multiple betamethasone doses if they have a high ongoing risk of preterm birth. However, concern existed regarding possible effects of these steroid doses on the infant in later childhood, particularly in cases of fetal growth restriction (FGR) because of “animal studies suggesting long-term adverse effects of treatment on neurosensory function,” Robert D. Cartwright of the University of Auckland (New Zealand), and his associates reported in JAMA Network Open.
Yet no such effects were identified in this preplanned follow-up analysis of the placebo-controlled, randomized Australasian Collaborative Trial of Repeat Doses of Corticosteroids (ACTORDS). “Physicians should use repeated doses of antenatal corticosteroids when indicated before preterm birth, regardless of fetal growth restriction, in view of the associated neonatal benefits and absence of later adverse effects,” the authors concluded.
The original ACTORDS study involved 982 women pregnant with 1,146 fetuses at 23 hospitals throughout Australia and New Zealand, enrolled from April 1998 to July 2004. All enrolled women were less than 32 weeks’ gestation, had received an initial course of corticosteroids, and had an ongoing risk of preterm birth at least 7 days later.
Women were randomly assigned to receive an intramuscular dose of betamethasone or saline placebo weekly until birth or preterm birth risk abated. The current follow-up, when children were 6-8 years old, was planned during the 2-year follow-up. Children underwent a pediatrician’s physical and neurologic exam, vision and hearing screening, and fine and gross motor testing. A psychologist tested children’s IQ, attention, executive function, and academic skills using standardized, validated assessment tools. Caregivers also rated children’s behavioral and emotional problems, executive function abilities, and attention in questionnaires.
Among 988 of 1,059 surviving children assessed, FGR occurred in 28% of children exposed to betamethasone and 25% in the placebo group.
For the primary outcomes, rates of disability-free survival were similar in both the placebo and betamethasone groups for children with (odds ratio, 1.1) and without FGR (OR, 1.0). Rates also were similar for death or survival with moderate to severe disability (FGR: OR, 0.9; and non-FGR: OR, 0.8).
“Some evidence suggested a differential effect for several secondary outcomes, with better scores for selective and divided attention after exposure to repeated antenatal betamethasone in children with FGR, but poorer scores for impulse control in children without FGR,” Dr. Cartwright and his associates reported. “These effects were small and of uncertain clinical significance and may reflect type I error.
“For all other measures of neurocognitive function and learning, exposure to repeated antenatal betamethasone treatment did not alter performance in midchildhood, even in the presence of FGR,” they added.
Children with FGR had an increased risk of death or moderate to severe disability, compared with children without FGR, regardless of treatment group. Those with FGR also had greater risk of motor impairment.
One possible reason for not finding adverse neurocognitive effects in the betamethasone group is “that infants with fetal growth restriction appeared to have greater benefit from repeated antenatal corticosteroid therapy, with a nearly twofold reduction in serious neonatal morbidity,” the authors surmised. “Thus, the decrease in serious postnatal complications may have counteracted any potential adverse effects of corticosteroid exposure.” But they noted a continuing concern about whether “repeated antenatal corticosteroids in FGR could increase the risk of ADHD.”
The research was funded by the National Health Medical Research Council of Australia, the Health Research Council of New Zealand and the Auckland Medical Research Foundation. One coauthor reported receiving grants from National Health and Medical Research Council of Australia, and a second coauthor received grants from the Auckland Medical Research Foundation.
SOURCE: Cartwright RD et al. JAMA Netw Open. 2019 Feb 1. doi:10.1001/jamanetworkopen.2018.7636.
Administering prenatal corticosteroids to women at risk for preterm birth does not appear to contribute to adverse neurocognitive function in children 6-8 years later, regardless of whether they had fetal growth restriction, a new study found.
Women at less than 32 weeks’ gestation are recommended to receive multiple betamethasone doses if they have a high ongoing risk of preterm birth. However, concern existed regarding possible effects of these steroid doses on the infant in later childhood, particularly in cases of fetal growth restriction (FGR) because of “animal studies suggesting long-term adverse effects of treatment on neurosensory function,” Robert D. Cartwright of the University of Auckland (New Zealand), and his associates reported in JAMA Network Open.
Yet no such effects were identified in this preplanned follow-up analysis of the placebo-controlled, randomized Australasian Collaborative Trial of Repeat Doses of Corticosteroids (ACTORDS). “Physicians should use repeated doses of antenatal corticosteroids when indicated before preterm birth, regardless of fetal growth restriction, in view of the associated neonatal benefits and absence of later adverse effects,” the authors concluded.
The original ACTORDS study involved 982 women pregnant with 1,146 fetuses at 23 hospitals throughout Australia and New Zealand, enrolled from April 1998 to July 2004. All enrolled women were less than 32 weeks’ gestation, had received an initial course of corticosteroids, and had an ongoing risk of preterm birth at least 7 days later.
Women were randomly assigned to receive an intramuscular dose of betamethasone or saline placebo weekly until birth or preterm birth risk abated. The current follow-up, when children were 6-8 years old, was planned during the 2-year follow-up. Children underwent a pediatrician’s physical and neurologic exam, vision and hearing screening, and fine and gross motor testing. A psychologist tested children’s IQ, attention, executive function, and academic skills using standardized, validated assessment tools. Caregivers also rated children’s behavioral and emotional problems, executive function abilities, and attention in questionnaires.
Among 988 of 1,059 surviving children assessed, FGR occurred in 28% of children exposed to betamethasone and 25% in the placebo group.
For the primary outcomes, rates of disability-free survival were similar in both the placebo and betamethasone groups for children with (odds ratio, 1.1) and without FGR (OR, 1.0). Rates also were similar for death or survival with moderate to severe disability (FGR: OR, 0.9; and non-FGR: OR, 0.8).
“Some evidence suggested a differential effect for several secondary outcomes, with better scores for selective and divided attention after exposure to repeated antenatal betamethasone in children with FGR, but poorer scores for impulse control in children without FGR,” Dr. Cartwright and his associates reported. “These effects were small and of uncertain clinical significance and may reflect type I error.
“For all other measures of neurocognitive function and learning, exposure to repeated antenatal betamethasone treatment did not alter performance in midchildhood, even in the presence of FGR,” they added.
Children with FGR had an increased risk of death or moderate to severe disability, compared with children without FGR, regardless of treatment group. Those with FGR also had greater risk of motor impairment.
One possible reason for not finding adverse neurocognitive effects in the betamethasone group is “that infants with fetal growth restriction appeared to have greater benefit from repeated antenatal corticosteroid therapy, with a nearly twofold reduction in serious neonatal morbidity,” the authors surmised. “Thus, the decrease in serious postnatal complications may have counteracted any potential adverse effects of corticosteroid exposure.” But they noted a continuing concern about whether “repeated antenatal corticosteroids in FGR could increase the risk of ADHD.”
The research was funded by the National Health Medical Research Council of Australia, the Health Research Council of New Zealand and the Auckland Medical Research Foundation. One coauthor reported receiving grants from National Health and Medical Research Council of Australia, and a second coauthor received grants from the Auckland Medical Research Foundation.
SOURCE: Cartwright RD et al. JAMA Netw Open. 2019 Feb 1. doi:10.1001/jamanetworkopen.2018.7636.
FROM JAMA NETWORK OPEN