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Opiate drug detox appears safe in pregnancy
ATLANTA – Contrary to conventional wisdom and standard obstetrical practice, opiate-addicted women can safely undergo detoxification during pregnancy, findings in more than 300 women suggest.
Over a 5-year period, 301 women with opiate addiction were detoxed during pregnancy with no adverse fetal outcomes related to the detox identified, Dr. Jennifer Bell reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Of the women studied, 108 were acutely detoxed while incarcerated, 100 went through inpatient detox, and 93 went through slow outpatient Subutex detox over 6-12 weeks. Relapse rates in those groups were 19%, 71%, and 15%, respectively.
However, among 23 women in the inpatient detox group who had close outpatient follow-up management, the relapse rate was 17% versus the 71% overall relapse rate with inpatient detox, said Dr. Bell, a third-year resident at the University of Tennessee Medical Center, Knoxville.
No cases of intrauterine fetal demise (IUFD) occurred during the course of the study, and the rate of preterm delivery did not differ between detox groups, Dr. Bell noted.
The rate of preterm delivery was 17% overall (51 patients), but 28 of the patients were induced for suspected intrauterine growth restriction. Only 16 had the condition.
Detox was slightly more expensive than drug maintenance in this study, but was cost saving when considered against the cost of treating one newborn with neonatal abstinence syndrome – $63,000 on average nationally.
Standard practice is to not detoxify opiate-addicted pregnant women, based primarily on two case reports from the 1970s that suggested fetal harm from detox. However, in the current study and five other studies published since that time, a total of 684 patients have been detoxed with no cases of IUFD, suggesting that detox is not harmful during pregnancy. And though relapse rates are high, this is typically among women who do not have continual follow-up management, according to Dr. Bell.
Once a patient is drug free, intense patient behavioral health follow-up is needed for success, Dr. Craig V. Towers, the lead author on the study, said in an interview. Such follow-up is costly, but not nearly as costly as caring for infants with neonatal abstinence syndrome, he said.
In Tennessee alone, where approximately 1,000 cases of neonatal abstinence syndrome occur each year, a 50% reduction in these cases could save more than $30 million per year, said Dr. Towers, also of the University of Tennessee Medical Center.
The framework for follow-up management programs for women who undergo detox could be paid for with a portion of those savings, said Dr. Towers, who is currently working with the state health department on developing a plan for such an approach to the problems of opiate addiction in pregnancy.
The current findings represent the first step toward an improved system, as many women who become pregnant while addicted to opiate drugs desire to detox, but aren’t given the option, he said. “We need to get rid of this argument that [detox] is harmful to the baby.”
The researchers reported having no financial disclosures.
ATLANTA – Contrary to conventional wisdom and standard obstetrical practice, opiate-addicted women can safely undergo detoxification during pregnancy, findings in more than 300 women suggest.
Over a 5-year period, 301 women with opiate addiction were detoxed during pregnancy with no adverse fetal outcomes related to the detox identified, Dr. Jennifer Bell reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Of the women studied, 108 were acutely detoxed while incarcerated, 100 went through inpatient detox, and 93 went through slow outpatient Subutex detox over 6-12 weeks. Relapse rates in those groups were 19%, 71%, and 15%, respectively.
However, among 23 women in the inpatient detox group who had close outpatient follow-up management, the relapse rate was 17% versus the 71% overall relapse rate with inpatient detox, said Dr. Bell, a third-year resident at the University of Tennessee Medical Center, Knoxville.
No cases of intrauterine fetal demise (IUFD) occurred during the course of the study, and the rate of preterm delivery did not differ between detox groups, Dr. Bell noted.
The rate of preterm delivery was 17% overall (51 patients), but 28 of the patients were induced for suspected intrauterine growth restriction. Only 16 had the condition.
Detox was slightly more expensive than drug maintenance in this study, but was cost saving when considered against the cost of treating one newborn with neonatal abstinence syndrome – $63,000 on average nationally.
Standard practice is to not detoxify opiate-addicted pregnant women, based primarily on two case reports from the 1970s that suggested fetal harm from detox. However, in the current study and five other studies published since that time, a total of 684 patients have been detoxed with no cases of IUFD, suggesting that detox is not harmful during pregnancy. And though relapse rates are high, this is typically among women who do not have continual follow-up management, according to Dr. Bell.
Once a patient is drug free, intense patient behavioral health follow-up is needed for success, Dr. Craig V. Towers, the lead author on the study, said in an interview. Such follow-up is costly, but not nearly as costly as caring for infants with neonatal abstinence syndrome, he said.
In Tennessee alone, where approximately 1,000 cases of neonatal abstinence syndrome occur each year, a 50% reduction in these cases could save more than $30 million per year, said Dr. Towers, also of the University of Tennessee Medical Center.
The framework for follow-up management programs for women who undergo detox could be paid for with a portion of those savings, said Dr. Towers, who is currently working with the state health department on developing a plan for such an approach to the problems of opiate addiction in pregnancy.
The current findings represent the first step toward an improved system, as many women who become pregnant while addicted to opiate drugs desire to detox, but aren’t given the option, he said. “We need to get rid of this argument that [detox] is harmful to the baby.”
The researchers reported having no financial disclosures.
ATLANTA – Contrary to conventional wisdom and standard obstetrical practice, opiate-addicted women can safely undergo detoxification during pregnancy, findings in more than 300 women suggest.
Over a 5-year period, 301 women with opiate addiction were detoxed during pregnancy with no adverse fetal outcomes related to the detox identified, Dr. Jennifer Bell reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Of the women studied, 108 were acutely detoxed while incarcerated, 100 went through inpatient detox, and 93 went through slow outpatient Subutex detox over 6-12 weeks. Relapse rates in those groups were 19%, 71%, and 15%, respectively.
However, among 23 women in the inpatient detox group who had close outpatient follow-up management, the relapse rate was 17% versus the 71% overall relapse rate with inpatient detox, said Dr. Bell, a third-year resident at the University of Tennessee Medical Center, Knoxville.
No cases of intrauterine fetal demise (IUFD) occurred during the course of the study, and the rate of preterm delivery did not differ between detox groups, Dr. Bell noted.
The rate of preterm delivery was 17% overall (51 patients), but 28 of the patients were induced for suspected intrauterine growth restriction. Only 16 had the condition.
Detox was slightly more expensive than drug maintenance in this study, but was cost saving when considered against the cost of treating one newborn with neonatal abstinence syndrome – $63,000 on average nationally.
Standard practice is to not detoxify opiate-addicted pregnant women, based primarily on two case reports from the 1970s that suggested fetal harm from detox. However, in the current study and five other studies published since that time, a total of 684 patients have been detoxed with no cases of IUFD, suggesting that detox is not harmful during pregnancy. And though relapse rates are high, this is typically among women who do not have continual follow-up management, according to Dr. Bell.
Once a patient is drug free, intense patient behavioral health follow-up is needed for success, Dr. Craig V. Towers, the lead author on the study, said in an interview. Such follow-up is costly, but not nearly as costly as caring for infants with neonatal abstinence syndrome, he said.
In Tennessee alone, where approximately 1,000 cases of neonatal abstinence syndrome occur each year, a 50% reduction in these cases could save more than $30 million per year, said Dr. Towers, also of the University of Tennessee Medical Center.
The framework for follow-up management programs for women who undergo detox could be paid for with a portion of those savings, said Dr. Towers, who is currently working with the state health department on developing a plan for such an approach to the problems of opiate addiction in pregnancy.
The current findings represent the first step toward an improved system, as many women who become pregnant while addicted to opiate drugs desire to detox, but aren’t given the option, he said. “We need to get rid of this argument that [detox] is harmful to the baby.”
The researchers reported having no financial disclosures.
AT THE PREGNANCY MEETING
Key clinical point: Opiate-addicted pregnant women can safely undergo detoxification.
Major finding: There were no cases of intrauterine fetal demise among women who underwent detox.
Data source: A review of detox approaches in 301 opiate-addicted pregnant women.
Disclosures: The researchers reported having no financial disclosures.
Sleep duration linked with gestational weight gain
ATLANTA – Both short and long sleep duration during pregnancy are associated with extremes of gestational weight gain, according to findings from a multicenter prospective cohort study.
Among 760 nulliparous women with a singleton gestation who were part of the nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring mothers-to-be) network – a National Institute of Child Health and Human Development cohort of more than 10,000 women – the 2.1% with average sleep duration of fewer than 6 hours and the 5.2% with sleep duration greater than 9 hours had the highest rates of low gestational weight gain (z less than –1). The differences were statistically significant, compared with those with average sleep duration of 7 to fewer than 9 hours, at visits between 16 and 21 weeks and between 22 and 29 weeks (P less than .0001, P = .04, respectively), Dr. Francesca Facco reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
For example, at visit 2, the rate of low gestational weight gain was 18.8% and 35.5% for those with sleep duration fewer than 6 hours and more than 9 hours, respectively, vs. 8.2% for those with sleep duration of 6 to fewer than 7 hours, and 12% for those with 7 to fewer than 8 hours.
The differences were similar in magnitude at the last weight measure prior to delivery but did not reach statistical significance, said Dr. Facco of Magee-Women’s Research Institute, University of Pittsburgh.
“Nonlinear relationships were observed between sleep duration and gestational weight gain,” she said, adding that at all gestational weight gain assessments, high gestational weight gain occurred more frequently as sleep duration shortened.
“We found a U-shaped relationship between sleep and low gestational weight gain; women with the shortest and the longest sleep duration had the highest rates of low gestational weight gain,” she said.
The findings suggest that both long and short sleep duration are associated with extremes of gestational weight gain.
Study subjects were enrolled in the nuMoM2b study and were recruited at the second study visit (16-21 weeks) to wear an actigraph to measure sleep activity for 7 consecutive days. The women, who had a mean age of 27 years, also kept a sleep diary. A little over half (51.5%) were normal weight, 3% were underweight, and 45.5% were overweight or obese. Gestational weight gain was examined using age-standardized z scores, which are a measure of gestational weight gain uncorrelated with gestational age and body mass index.
Sleep is getting more and more attention as an important health behavior, especially in relation to weight and metabolism, Dr. Facco said, noting that short sleep duration has consistently been associated with higher body mass index, and studies show that short sleep duration hinders weight loss efforts.
Data on long sleep duration are less clear but suggest an age-dependent relationship, she said.
The current study was undertaken to evaluate whether the findings in nonpregnant women also apply during pregnancy.
Data from the same cohort, which were presented at the 2015 Pregnancy Meeting, showed that women with sleep duration of fewer than 7 hours had twice the rate of gestational diabetes, compared with those who slept 7 or more hours. The finding remained significant even after adjusting for age and body mass index. Those findings are congruous with the current findings, Dr. Facco said, explaining that the short sleepers were those most likely to have the greatest weight gain, thus putting them at higher risk of gestational diabetes.
“Poor sleep in pregnancy has been linked to adverse pregnancy outcomes, and this association between sleep and gestational weight gain suggests one possible mechanism for this association,” she concluded.
The nuMoM2b study is funded by the National Institutes of Health. Dr. Facco reported having no conflicts of interest.
ATLANTA – Both short and long sleep duration during pregnancy are associated with extremes of gestational weight gain, according to findings from a multicenter prospective cohort study.
Among 760 nulliparous women with a singleton gestation who were part of the nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring mothers-to-be) network – a National Institute of Child Health and Human Development cohort of more than 10,000 women – the 2.1% with average sleep duration of fewer than 6 hours and the 5.2% with sleep duration greater than 9 hours had the highest rates of low gestational weight gain (z less than –1). The differences were statistically significant, compared with those with average sleep duration of 7 to fewer than 9 hours, at visits between 16 and 21 weeks and between 22 and 29 weeks (P less than .0001, P = .04, respectively), Dr. Francesca Facco reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
For example, at visit 2, the rate of low gestational weight gain was 18.8% and 35.5% for those with sleep duration fewer than 6 hours and more than 9 hours, respectively, vs. 8.2% for those with sleep duration of 6 to fewer than 7 hours, and 12% for those with 7 to fewer than 8 hours.
The differences were similar in magnitude at the last weight measure prior to delivery but did not reach statistical significance, said Dr. Facco of Magee-Women’s Research Institute, University of Pittsburgh.
“Nonlinear relationships were observed between sleep duration and gestational weight gain,” she said, adding that at all gestational weight gain assessments, high gestational weight gain occurred more frequently as sleep duration shortened.
“We found a U-shaped relationship between sleep and low gestational weight gain; women with the shortest and the longest sleep duration had the highest rates of low gestational weight gain,” she said.
The findings suggest that both long and short sleep duration are associated with extremes of gestational weight gain.
Study subjects were enrolled in the nuMoM2b study and were recruited at the second study visit (16-21 weeks) to wear an actigraph to measure sleep activity for 7 consecutive days. The women, who had a mean age of 27 years, also kept a sleep diary. A little over half (51.5%) were normal weight, 3% were underweight, and 45.5% were overweight or obese. Gestational weight gain was examined using age-standardized z scores, which are a measure of gestational weight gain uncorrelated with gestational age and body mass index.
Sleep is getting more and more attention as an important health behavior, especially in relation to weight and metabolism, Dr. Facco said, noting that short sleep duration has consistently been associated with higher body mass index, and studies show that short sleep duration hinders weight loss efforts.
Data on long sleep duration are less clear but suggest an age-dependent relationship, she said.
The current study was undertaken to evaluate whether the findings in nonpregnant women also apply during pregnancy.
Data from the same cohort, which were presented at the 2015 Pregnancy Meeting, showed that women with sleep duration of fewer than 7 hours had twice the rate of gestational diabetes, compared with those who slept 7 or more hours. The finding remained significant even after adjusting for age and body mass index. Those findings are congruous with the current findings, Dr. Facco said, explaining that the short sleepers were those most likely to have the greatest weight gain, thus putting them at higher risk of gestational diabetes.
“Poor sleep in pregnancy has been linked to adverse pregnancy outcomes, and this association between sleep and gestational weight gain suggests one possible mechanism for this association,” she concluded.
The nuMoM2b study is funded by the National Institutes of Health. Dr. Facco reported having no conflicts of interest.
ATLANTA – Both short and long sleep duration during pregnancy are associated with extremes of gestational weight gain, according to findings from a multicenter prospective cohort study.
Among 760 nulliparous women with a singleton gestation who were part of the nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring mothers-to-be) network – a National Institute of Child Health and Human Development cohort of more than 10,000 women – the 2.1% with average sleep duration of fewer than 6 hours and the 5.2% with sleep duration greater than 9 hours had the highest rates of low gestational weight gain (z less than –1). The differences were statistically significant, compared with those with average sleep duration of 7 to fewer than 9 hours, at visits between 16 and 21 weeks and between 22 and 29 weeks (P less than .0001, P = .04, respectively), Dr. Francesca Facco reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
For example, at visit 2, the rate of low gestational weight gain was 18.8% and 35.5% for those with sleep duration fewer than 6 hours and more than 9 hours, respectively, vs. 8.2% for those with sleep duration of 6 to fewer than 7 hours, and 12% for those with 7 to fewer than 8 hours.
The differences were similar in magnitude at the last weight measure prior to delivery but did not reach statistical significance, said Dr. Facco of Magee-Women’s Research Institute, University of Pittsburgh.
“Nonlinear relationships were observed between sleep duration and gestational weight gain,” she said, adding that at all gestational weight gain assessments, high gestational weight gain occurred more frequently as sleep duration shortened.
“We found a U-shaped relationship between sleep and low gestational weight gain; women with the shortest and the longest sleep duration had the highest rates of low gestational weight gain,” she said.
The findings suggest that both long and short sleep duration are associated with extremes of gestational weight gain.
Study subjects were enrolled in the nuMoM2b study and were recruited at the second study visit (16-21 weeks) to wear an actigraph to measure sleep activity for 7 consecutive days. The women, who had a mean age of 27 years, also kept a sleep diary. A little over half (51.5%) were normal weight, 3% were underweight, and 45.5% were overweight or obese. Gestational weight gain was examined using age-standardized z scores, which are a measure of gestational weight gain uncorrelated with gestational age and body mass index.
Sleep is getting more and more attention as an important health behavior, especially in relation to weight and metabolism, Dr. Facco said, noting that short sleep duration has consistently been associated with higher body mass index, and studies show that short sleep duration hinders weight loss efforts.
Data on long sleep duration are less clear but suggest an age-dependent relationship, she said.
The current study was undertaken to evaluate whether the findings in nonpregnant women also apply during pregnancy.
Data from the same cohort, which were presented at the 2015 Pregnancy Meeting, showed that women with sleep duration of fewer than 7 hours had twice the rate of gestational diabetes, compared with those who slept 7 or more hours. The finding remained significant even after adjusting for age and body mass index. Those findings are congruous with the current findings, Dr. Facco said, explaining that the short sleepers were those most likely to have the greatest weight gain, thus putting them at higher risk of gestational diabetes.
“Poor sleep in pregnancy has been linked to adverse pregnancy outcomes, and this association between sleep and gestational weight gain suggests one possible mechanism for this association,” she concluded.
The nuMoM2b study is funded by the National Institutes of Health. Dr. Facco reported having no conflicts of interest.
AT THE PREGNANCY MEETING
Key clinical point: Both short and long sleep duration during pregnancy are associated with extremes of gestational weight gain, according to findings from a multicenter prospective cohort study.
Major finding: Women with average sleep duration less than 6 hours and greater than 9 hours had the highest rates of low gestational weight gain (18.8% and 35.5%, respectively, vs. 8.2% for those with 6 to under 7 hours, and 12% for those with 7 to under 8 hours).
Data source: A study of 760 women from a large prospective cohort.
Disclosures: The nuMoM2b study is funded by the National Institutes of Health. Dr. Facco reported having no conflicts of interest.
Treating maternal subclinical hypothyroidism doesn’t improve childhood IQ
ATLANTA – Prenatal treatment of maternal subclinical hypothyroidism or hypothyroxinemia conferred no cognitive, behavioral, or neurodevelopmental benefit to children up to age 5.
The findings of two parallel randomized trials suggest that prenatal screening for these conditions is not necessary, Dr. Brian Casey said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. The data also support the American College of Obstetricians and Gynecologists’ 2007 recommendation against routine screening, said Dr. Casey, chief of maternal-fetal medicine and obstetrics at the University of Texas Southwestern Medical Center, Dallas.
The issue of whether to treat pregnant women for subclinical hypothyroidism has been debated for years. Studies in the early 2000s suggested that prenatal levothyroxine did improve child neurocognitive outcomes, but more recent studies, including a 2012 randomized trial, do not.
These data have led both the American College of Obstetricians and Gynecologists and the Endocrine Society to recommend against screening for subclinical hypothyroidism in pregnant women.
Dr. Casey and his colleagues conducted two large parallel randomized studies, one in women with subclinical hypothyroidism and another in women with hypothyroxinemia. Subclinical hypothyroidism was defined as a thyroid stimulating hormone (TSH) level of at least 4 mU/L with normal free T4. Hypothyroxinemia was defined as a normal TSH but a free T4 of less than 0.86 ng/dL.
The primary outcome in each group was child IQ at 5 years. Secondary outcomes were scores on neurodevelopmental and behavioral measures, including the presence of attention deficit hyperactivity disorder, conducted at ages 3, 4, and 5 years.
All women in the trials had a singleton pregnancy of less than 20 weeks’ gestation, with no known history of thyroid disease.
The subclinical hypothyroidism group comprised 677 women. They were a mean of 27 years old, with a mean gestational age of 16.5 weeks. Baseline TSH was 4.5 mU/L; baseline free T4 was 1 ng/dL. All had normal urinary iodide. They were randomized to placebo or to daily 100 mcg levothyroxine. The treatment goal was a TSH of 0.1-2.5 mU/L. Most (93%) achieved this by 21 weeks’ gestation.
There was no significant difference in the primary outcome of child IQ at 5 years between the treated and untreated groups (97 vs. 94). On the Bayley Scales of Infant and Toddler Development, scores of cognition, motor skills, and language were similar in each group at both 12 and 24 months. The Differential Ability Scales scores at 3 and 4 years were also similar. The Child Behavior Checklist scores at ages 4 years and 5 years were similar. There was no indication of an increase in ADHD.
The hypothyroxinemia trial comprised 467 women. They were randomized to placebo or to 50 mcg levothyroxine. These women were a mean of 28 years old with a mean gestational age of 18 weeks. Their baseline TSH was 1.5 mU/L, and baseline free T4 was 0.8 ng/dL. All had normal urinary iodide. The treatment goal was a free T4 of between 0.86 and 1.90 ng/dL. Most (83%) achieved this by 23 weeks’ gestation.
There was no difference on the primary outcome of child IQ at 5 years (94 vs. 91). On the Bayley Scales of Infant and Toddler Development, scores of cognition, motor skills, and language were similar in each group at both 12 and 24 months. The Differential Ability Scales scores at 3 years and 4 years were also similar. The Child Behavior Checklist scores at ages 4years and 5 years were similar. There was no indication of an increase in ADHD.
Dr. Casey added that there was no interaction between gestational age at baseline and treatment outcomes, suggesting that there may be little foundation to the argument that treating earlier in pregnancy is key.
He had no financial disclosures.
ATLANTA – Prenatal treatment of maternal subclinical hypothyroidism or hypothyroxinemia conferred no cognitive, behavioral, or neurodevelopmental benefit to children up to age 5.
The findings of two parallel randomized trials suggest that prenatal screening for these conditions is not necessary, Dr. Brian Casey said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. The data also support the American College of Obstetricians and Gynecologists’ 2007 recommendation against routine screening, said Dr. Casey, chief of maternal-fetal medicine and obstetrics at the University of Texas Southwestern Medical Center, Dallas.
The issue of whether to treat pregnant women for subclinical hypothyroidism has been debated for years. Studies in the early 2000s suggested that prenatal levothyroxine did improve child neurocognitive outcomes, but more recent studies, including a 2012 randomized trial, do not.
These data have led both the American College of Obstetricians and Gynecologists and the Endocrine Society to recommend against screening for subclinical hypothyroidism in pregnant women.
Dr. Casey and his colleagues conducted two large parallel randomized studies, one in women with subclinical hypothyroidism and another in women with hypothyroxinemia. Subclinical hypothyroidism was defined as a thyroid stimulating hormone (TSH) level of at least 4 mU/L with normal free T4. Hypothyroxinemia was defined as a normal TSH but a free T4 of less than 0.86 ng/dL.
The primary outcome in each group was child IQ at 5 years. Secondary outcomes were scores on neurodevelopmental and behavioral measures, including the presence of attention deficit hyperactivity disorder, conducted at ages 3, 4, and 5 years.
All women in the trials had a singleton pregnancy of less than 20 weeks’ gestation, with no known history of thyroid disease.
The subclinical hypothyroidism group comprised 677 women. They were a mean of 27 years old, with a mean gestational age of 16.5 weeks. Baseline TSH was 4.5 mU/L; baseline free T4 was 1 ng/dL. All had normal urinary iodide. They were randomized to placebo or to daily 100 mcg levothyroxine. The treatment goal was a TSH of 0.1-2.5 mU/L. Most (93%) achieved this by 21 weeks’ gestation.
There was no significant difference in the primary outcome of child IQ at 5 years between the treated and untreated groups (97 vs. 94). On the Bayley Scales of Infant and Toddler Development, scores of cognition, motor skills, and language were similar in each group at both 12 and 24 months. The Differential Ability Scales scores at 3 and 4 years were also similar. The Child Behavior Checklist scores at ages 4 years and 5 years were similar. There was no indication of an increase in ADHD.
The hypothyroxinemia trial comprised 467 women. They were randomized to placebo or to 50 mcg levothyroxine. These women were a mean of 28 years old with a mean gestational age of 18 weeks. Their baseline TSH was 1.5 mU/L, and baseline free T4 was 0.8 ng/dL. All had normal urinary iodide. The treatment goal was a free T4 of between 0.86 and 1.90 ng/dL. Most (83%) achieved this by 23 weeks’ gestation.
There was no difference on the primary outcome of child IQ at 5 years (94 vs. 91). On the Bayley Scales of Infant and Toddler Development, scores of cognition, motor skills, and language were similar in each group at both 12 and 24 months. The Differential Ability Scales scores at 3 years and 4 years were also similar. The Child Behavior Checklist scores at ages 4years and 5 years were similar. There was no indication of an increase in ADHD.
Dr. Casey added that there was no interaction between gestational age at baseline and treatment outcomes, suggesting that there may be little foundation to the argument that treating earlier in pregnancy is key.
He had no financial disclosures.
ATLANTA – Prenatal treatment of maternal subclinical hypothyroidism or hypothyroxinemia conferred no cognitive, behavioral, or neurodevelopmental benefit to children up to age 5.
The findings of two parallel randomized trials suggest that prenatal screening for these conditions is not necessary, Dr. Brian Casey said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. The data also support the American College of Obstetricians and Gynecologists’ 2007 recommendation against routine screening, said Dr. Casey, chief of maternal-fetal medicine and obstetrics at the University of Texas Southwestern Medical Center, Dallas.
The issue of whether to treat pregnant women for subclinical hypothyroidism has been debated for years. Studies in the early 2000s suggested that prenatal levothyroxine did improve child neurocognitive outcomes, but more recent studies, including a 2012 randomized trial, do not.
These data have led both the American College of Obstetricians and Gynecologists and the Endocrine Society to recommend against screening for subclinical hypothyroidism in pregnant women.
Dr. Casey and his colleagues conducted two large parallel randomized studies, one in women with subclinical hypothyroidism and another in women with hypothyroxinemia. Subclinical hypothyroidism was defined as a thyroid stimulating hormone (TSH) level of at least 4 mU/L with normal free T4. Hypothyroxinemia was defined as a normal TSH but a free T4 of less than 0.86 ng/dL.
The primary outcome in each group was child IQ at 5 years. Secondary outcomes were scores on neurodevelopmental and behavioral measures, including the presence of attention deficit hyperactivity disorder, conducted at ages 3, 4, and 5 years.
All women in the trials had a singleton pregnancy of less than 20 weeks’ gestation, with no known history of thyroid disease.
The subclinical hypothyroidism group comprised 677 women. They were a mean of 27 years old, with a mean gestational age of 16.5 weeks. Baseline TSH was 4.5 mU/L; baseline free T4 was 1 ng/dL. All had normal urinary iodide. They were randomized to placebo or to daily 100 mcg levothyroxine. The treatment goal was a TSH of 0.1-2.5 mU/L. Most (93%) achieved this by 21 weeks’ gestation.
There was no significant difference in the primary outcome of child IQ at 5 years between the treated and untreated groups (97 vs. 94). On the Bayley Scales of Infant and Toddler Development, scores of cognition, motor skills, and language were similar in each group at both 12 and 24 months. The Differential Ability Scales scores at 3 and 4 years were also similar. The Child Behavior Checklist scores at ages 4 years and 5 years were similar. There was no indication of an increase in ADHD.
The hypothyroxinemia trial comprised 467 women. They were randomized to placebo or to 50 mcg levothyroxine. These women were a mean of 28 years old with a mean gestational age of 18 weeks. Their baseline TSH was 1.5 mU/L, and baseline free T4 was 0.8 ng/dL. All had normal urinary iodide. The treatment goal was a free T4 of between 0.86 and 1.90 ng/dL. Most (83%) achieved this by 23 weeks’ gestation.
There was no difference on the primary outcome of child IQ at 5 years (94 vs. 91). On the Bayley Scales of Infant and Toddler Development, scores of cognition, motor skills, and language were similar in each group at both 12 and 24 months. The Differential Ability Scales scores at 3 years and 4 years were also similar. The Child Behavior Checklist scores at ages 4years and 5 years were similar. There was no indication of an increase in ADHD.
Dr. Casey added that there was no interaction between gestational age at baseline and treatment outcomes, suggesting that there may be little foundation to the argument that treating earlier in pregnancy is key.
He had no financial disclosures.
AT THE PREGNANCY MEETING
Key clinical point: Levothyroxine for women with subclinical hypothyroidism didn’t boost childhood cognition.
Major finding: Child IQ at 5 years old was 97 in the treated group and 94 in the placebo group – not a significant difference.
Data source: The parallel randomized controlled trials comprised a total of 1,144 women.
Disclosures: Dr. Casey had no financial disclosures.
VIDEO: Could noninvasive prenatal testing mean gene profiling for every pregnancy?
ATLANTA – The decision of whether to screen a pregnancy for genetic anomalies should not be taken lightly, especially in light of the invasive procedures required. But what if a simple maternal blood test could provide everything we needed to know about a fetus’ genetic health?
At the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Ronald J. Wapner of Columbia University, New York, said that time is quickly approaching, and that cell-free fetal DNA testing should – and will – become a routine part of prenatal care.
Watch an interview with Dr. Wapner here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ATLANTA – The decision of whether to screen a pregnancy for genetic anomalies should not be taken lightly, especially in light of the invasive procedures required. But what if a simple maternal blood test could provide everything we needed to know about a fetus’ genetic health?
At the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Ronald J. Wapner of Columbia University, New York, said that time is quickly approaching, and that cell-free fetal DNA testing should – and will – become a routine part of prenatal care.
Watch an interview with Dr. Wapner here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ATLANTA – The decision of whether to screen a pregnancy for genetic anomalies should not be taken lightly, especially in light of the invasive procedures required. But what if a simple maternal blood test could provide everything we needed to know about a fetus’ genetic health?
At the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Ronald J. Wapner of Columbia University, New York, said that time is quickly approaching, and that cell-free fetal DNA testing should – and will – become a routine part of prenatal care.
Watch an interview with Dr. Wapner here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE PREGNANCY MEETING
VIDEO: To optimize children’s oral health, take care of moms first
ATLANTA – Oral health – whether poor or good – seems to run in families. Is it behavior, biology, or both?
At the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Renee Samelson, a maternal-fetal medicine specialist with a certification in preventive medicine, said that taking care of moms’ teeth and gums, even before pregnancy, gives children the best shot at maintaining a healthy mouth from infancy to old age.
Watch an interview with Dr. Samelson here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ATLANTA – Oral health – whether poor or good – seems to run in families. Is it behavior, biology, or both?
At the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Renee Samelson, a maternal-fetal medicine specialist with a certification in preventive medicine, said that taking care of moms’ teeth and gums, even before pregnancy, gives children the best shot at maintaining a healthy mouth from infancy to old age.
Watch an interview with Dr. Samelson here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ATLANTA – Oral health – whether poor or good – seems to run in families. Is it behavior, biology, or both?
At the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, Dr. Renee Samelson, a maternal-fetal medicine specialist with a certification in preventive medicine, said that taking care of moms’ teeth and gums, even before pregnancy, gives children the best shot at maintaining a healthy mouth from infancy to old age.
Watch an interview with Dr. Samelson here.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE PREGNANCY MEETING
Evidence-based bundles reduced shoulder dystocia rates
ATLANTA – Implementation of evidence-based practice bundles was associated with significant reductions in shoulder dystocia, brachial plexus injury, and operative vaginal delivery in a large multicenter hospital system.
From the 18 months prior to implementation of the bundles – which included a planned vaginal delivery tool to assess for shoulder dystocia risk – to the 36 months after implementation, the rate of shoulder dystocia decreased from 1.7 to 1.4 per 100 births, Dr. Laura Sienas reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“This is a 17.6% reduction in the rate of shoulder dystocia. There was a statistically significant association with increasing bundle compliance of both bundles with a decrease in shoulder dystocia,” said Dr. Sienas, a 3rd-year resident at the University of California, Davis.
Additionally, the rate of brachial plexus injury decreased significantly from 2.1 to 1.5 per 1,000 births (a 29% reduction), and the rate of operative vaginal deliveries also decreased significantly, from 6.1 to 5.0 per 100 births (an 18% reduction).
At the same time, there was no significant change in the primary and total Cesarean section rates: 16.5 per 100 births and 30.1 per 100 births, respectively, she noted.
Key elements of the evidence-based practice bundles included an admission risk assessment, and a review and timeout prior to operative vaginal delivery. Low-fidelity shoulder dystocia drills were also introduced for nurses and physicians. While the drills improved teamwork and communication, they did not result in decreased brachial plexus injury rates, Dr. Sienas noted.
Future research should consider whether high-fidelity drills would lower the rate of brachial plexus injury, she added.
Data for this study was collected from 29 maternal centers, with size ranging from small and rural with fewer than 200 deliveries each year, to large urban hospitals with about 5,000 annual births. Baseline data included all singleton vertex births over 34 weeks’ gestation – about 169,000 total births. After all participating centers attained 90% compliance with the evidence-based practice bundles, about 103,000 deliveries occurred. Compliance with the bundles was scored as all or none.
The 29 hospitals in the health system where this study took place have average delivery volumes between 150 and 5,000 births per year, suggesting that the current findings would be applicable to nearly all delivery units in the United States, she said.
Dr. Sienas reported having no financial disclosures.
ATLANTA – Implementation of evidence-based practice bundles was associated with significant reductions in shoulder dystocia, brachial plexus injury, and operative vaginal delivery in a large multicenter hospital system.
From the 18 months prior to implementation of the bundles – which included a planned vaginal delivery tool to assess for shoulder dystocia risk – to the 36 months after implementation, the rate of shoulder dystocia decreased from 1.7 to 1.4 per 100 births, Dr. Laura Sienas reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“This is a 17.6% reduction in the rate of shoulder dystocia. There was a statistically significant association with increasing bundle compliance of both bundles with a decrease in shoulder dystocia,” said Dr. Sienas, a 3rd-year resident at the University of California, Davis.
Additionally, the rate of brachial plexus injury decreased significantly from 2.1 to 1.5 per 1,000 births (a 29% reduction), and the rate of operative vaginal deliveries also decreased significantly, from 6.1 to 5.0 per 100 births (an 18% reduction).
At the same time, there was no significant change in the primary and total Cesarean section rates: 16.5 per 100 births and 30.1 per 100 births, respectively, she noted.
Key elements of the evidence-based practice bundles included an admission risk assessment, and a review and timeout prior to operative vaginal delivery. Low-fidelity shoulder dystocia drills were also introduced for nurses and physicians. While the drills improved teamwork and communication, they did not result in decreased brachial plexus injury rates, Dr. Sienas noted.
Future research should consider whether high-fidelity drills would lower the rate of brachial plexus injury, she added.
Data for this study was collected from 29 maternal centers, with size ranging from small and rural with fewer than 200 deliveries each year, to large urban hospitals with about 5,000 annual births. Baseline data included all singleton vertex births over 34 weeks’ gestation – about 169,000 total births. After all participating centers attained 90% compliance with the evidence-based practice bundles, about 103,000 deliveries occurred. Compliance with the bundles was scored as all or none.
The 29 hospitals in the health system where this study took place have average delivery volumes between 150 and 5,000 births per year, suggesting that the current findings would be applicable to nearly all delivery units in the United States, she said.
Dr. Sienas reported having no financial disclosures.
ATLANTA – Implementation of evidence-based practice bundles was associated with significant reductions in shoulder dystocia, brachial plexus injury, and operative vaginal delivery in a large multicenter hospital system.
From the 18 months prior to implementation of the bundles – which included a planned vaginal delivery tool to assess for shoulder dystocia risk – to the 36 months after implementation, the rate of shoulder dystocia decreased from 1.7 to 1.4 per 100 births, Dr. Laura Sienas reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“This is a 17.6% reduction in the rate of shoulder dystocia. There was a statistically significant association with increasing bundle compliance of both bundles with a decrease in shoulder dystocia,” said Dr. Sienas, a 3rd-year resident at the University of California, Davis.
Additionally, the rate of brachial plexus injury decreased significantly from 2.1 to 1.5 per 1,000 births (a 29% reduction), and the rate of operative vaginal deliveries also decreased significantly, from 6.1 to 5.0 per 100 births (an 18% reduction).
At the same time, there was no significant change in the primary and total Cesarean section rates: 16.5 per 100 births and 30.1 per 100 births, respectively, she noted.
Key elements of the evidence-based practice bundles included an admission risk assessment, and a review and timeout prior to operative vaginal delivery. Low-fidelity shoulder dystocia drills were also introduced for nurses and physicians. While the drills improved teamwork and communication, they did not result in decreased brachial plexus injury rates, Dr. Sienas noted.
Future research should consider whether high-fidelity drills would lower the rate of brachial plexus injury, she added.
Data for this study was collected from 29 maternal centers, with size ranging from small and rural with fewer than 200 deliveries each year, to large urban hospitals with about 5,000 annual births. Baseline data included all singleton vertex births over 34 weeks’ gestation – about 169,000 total births. After all participating centers attained 90% compliance with the evidence-based practice bundles, about 103,000 deliveries occurred. Compliance with the bundles was scored as all or none.
The 29 hospitals in the health system where this study took place have average delivery volumes between 150 and 5,000 births per year, suggesting that the current findings would be applicable to nearly all delivery units in the United States, she said.
Dr. Sienas reported having no financial disclosures.
AT THE PREGNANCY MEETING
Key clinical point: Use of evidence-based practice bundles helped reduce rates of shoulder dystocia, brachial plexus injury, and operative vaginal delivery.
Major finding: Shoulder dystocia rates dropped by 17.6% and brachial plexus injuries by 29% with implementation of the bundles.
Data source: A multicenter prospective study of more than 100,000 births.
Disclosures: Dr. Sienas reported having no financial disclosures.
VIDEO: SMFM panelist addresses Zika virus testing
ATLANTA – Information about managing pregnant patients who have potential exposure to the Zika virus is evolving rapidly, and in light of new recommendations on sexual transmission of the infection, officials from the Society for Maternal-Fetal Medicine convened an expert panel to address the matter.
Leaders from the society joined officials from the Centers for Disease Control and Prevention to discuss the updated guidance – particularly a new recommendation for initially conducting serologic testing in pregnant women who have traveled to endemic areas.
Panel members advised physicians to keep a log of patients with possible Zika virus exposure, so those women can be managed properly in the event of future changes to the guidelines.
In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, panelist Dr. Brenna Hughes of Brown University, Providence, R.I., stressed the need to work with state health officials to develop local guidelines and testing mechanisms. “It will take a little time to build up the infrastructure for that kind of testing,” she said, adding that it is important to avoid delays.
Dr. Hughes reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ATLANTA – Information about managing pregnant patients who have potential exposure to the Zika virus is evolving rapidly, and in light of new recommendations on sexual transmission of the infection, officials from the Society for Maternal-Fetal Medicine convened an expert panel to address the matter.
Leaders from the society joined officials from the Centers for Disease Control and Prevention to discuss the updated guidance – particularly a new recommendation for initially conducting serologic testing in pregnant women who have traveled to endemic areas.
Panel members advised physicians to keep a log of patients with possible Zika virus exposure, so those women can be managed properly in the event of future changes to the guidelines.
In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, panelist Dr. Brenna Hughes of Brown University, Providence, R.I., stressed the need to work with state health officials to develop local guidelines and testing mechanisms. “It will take a little time to build up the infrastructure for that kind of testing,” she said, adding that it is important to avoid delays.
Dr. Hughes reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ATLANTA – Information about managing pregnant patients who have potential exposure to the Zika virus is evolving rapidly, and in light of new recommendations on sexual transmission of the infection, officials from the Society for Maternal-Fetal Medicine convened an expert panel to address the matter.
Leaders from the society joined officials from the Centers for Disease Control and Prevention to discuss the updated guidance – particularly a new recommendation for initially conducting serologic testing in pregnant women who have traveled to endemic areas.
Panel members advised physicians to keep a log of patients with possible Zika virus exposure, so those women can be managed properly in the event of future changes to the guidelines.
In an interview at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine, panelist Dr. Brenna Hughes of Brown University, Providence, R.I., stressed the need to work with state health officials to develop local guidelines and testing mechanisms. “It will take a little time to build up the infrastructure for that kind of testing,” she said, adding that it is important to avoid delays.
Dr. Hughes reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE PREGNANCY MEETING
OPPTIMUM Trial: No benefit found for vaginal progesterone in preterm birth prevention
ATLANTA – Vaginal progesterone confers no obstetrical or neonatal benefit, and no long-term benefit with respect to cognitive and neurosensory outcomes in children when used to prevent preterm birth, according to findings from the randomized, controlled, double-blind OPPTIMUM trial.
The findings from OPPTIMUM – the largest trial to date looking at progesterone for the prevention of preterm birth – have important implications for current practice. Vaginal progesterone is not currently approved for the prevention of preterm birth in the United States, but is commonly used off label for this purpose.
Prior studies have demonstrated a benefit with respect to progesterone for the prevention of preterm birth, particularly in women with a short cervix, but no studies have looked at long-term outcomes, Dr. Jane E. Norman of the University of Edinburgh reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
In OPPTIMUM, the rate of the primary obstetric outcome of preterm birth or fetal death before 34 weeks’ gestation did not differ significantly for 618 women at risk for preterm birth who were randomized to receive 200 mg of vaginal progesterone daily starting at 22-24 weeks and continuing to 34 weeks’ gestation, compared with 600 women who received placebo (16% vs. 18%; odds ratio, 0.86), Dr. Norman said.
The rate of the primary neonatal composite outcome of death or major morbidity (brain injury or bronchopulmonary dysplasia) also did not differ significantly between the progesterone and placebo groups after a prespecified multiple comparisons procedure (6% vs. 10%; odds ratio, 0.62).
A secondary analysis looking at the individual components of the composite neonatal outcomes showed that progesterone reduced the risk of brain injury and neonatal death, but not bronchopulmonary dysplasia, she said.
Further, no difference was seen in Bayley III cognitive scores (with values imputed for deaths) at 2 years of age in 439 and 430 children born to mothers in the progesterone and placebo groups, respectively (average scores, 97.7 and 97.3; odds ratio, 0.48).
On secondary analyses, some safety signals were noted with respect to neurodevelopmental outcomes.
“We were really surprised that we didn’t show that progesterone prevented preterm birth, and we became concerned that perhaps our cutoff of 34 weeks was just the wrong time to choose a cutoff,” Dr. Norman said, noting that a post hoc survival curve analysis was performed to look at the trajectory to delivery, and a “very marginal benefit” was seen with progesterone, but the difference was not statistically significant.
In addition, subgroup analyses showed no significant benefit of progesterone on obstetrical, neonatal, or childhood outcomes. For example, in women with a short cervix, no evidence was seen that progesterone was more or less effective than in women with a longer cervix. Other subgroups studied included fibronectin-positive and fibronectin-negative women and women with a history of preterm birth. Progesterone was no more or less effective in any of the subgroups, Dr. Norman said.
OPPTIMUM study subjects were women at risk of preterm birth because of a positive fetal fibronectin test result, a history of spontaneous preterm birth at or before 34 weeks’ gestation, or a short cervix (25 mm or less).
All outcomes were adjusted for a previous pregnancy of 14 weeks’ gestation or greater, with study center as a random effect.
“OPPTIMUM is the largest trial of progesterone to prevent preterm birth, and after adjusting for multiple comparisons as we planned, we did not disprove the null hypothesis that progesterone doesn’t prevent preterm birth, it doesn’t reduce adverse neonatal outcomes, and it doesn’t have a beneficial effect on childhood outcomes,” Dr. Norman said, concluding that “there is a remaining unmet need for a safe and effective agent to prevent preterm birth.”
Asked about the safety of progesterone given the findings from secondary analyses in OPPTIMUM, she said, “I would not advise my daughter to take progesterone if she’s pregnant.”
The study drug and placebo were donated by Besins, but the company was not involved in study design or analysis. Funding was provided by the Medical Research Council. Dr. Norman reported having no relevant financial disclosures.
ATLANTA – Vaginal progesterone confers no obstetrical or neonatal benefit, and no long-term benefit with respect to cognitive and neurosensory outcomes in children when used to prevent preterm birth, according to findings from the randomized, controlled, double-blind OPPTIMUM trial.
The findings from OPPTIMUM – the largest trial to date looking at progesterone for the prevention of preterm birth – have important implications for current practice. Vaginal progesterone is not currently approved for the prevention of preterm birth in the United States, but is commonly used off label for this purpose.
Prior studies have demonstrated a benefit with respect to progesterone for the prevention of preterm birth, particularly in women with a short cervix, but no studies have looked at long-term outcomes, Dr. Jane E. Norman of the University of Edinburgh reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
In OPPTIMUM, the rate of the primary obstetric outcome of preterm birth or fetal death before 34 weeks’ gestation did not differ significantly for 618 women at risk for preterm birth who were randomized to receive 200 mg of vaginal progesterone daily starting at 22-24 weeks and continuing to 34 weeks’ gestation, compared with 600 women who received placebo (16% vs. 18%; odds ratio, 0.86), Dr. Norman said.
The rate of the primary neonatal composite outcome of death or major morbidity (brain injury or bronchopulmonary dysplasia) also did not differ significantly between the progesterone and placebo groups after a prespecified multiple comparisons procedure (6% vs. 10%; odds ratio, 0.62).
A secondary analysis looking at the individual components of the composite neonatal outcomes showed that progesterone reduced the risk of brain injury and neonatal death, but not bronchopulmonary dysplasia, she said.
Further, no difference was seen in Bayley III cognitive scores (with values imputed for deaths) at 2 years of age in 439 and 430 children born to mothers in the progesterone and placebo groups, respectively (average scores, 97.7 and 97.3; odds ratio, 0.48).
On secondary analyses, some safety signals were noted with respect to neurodevelopmental outcomes.
“We were really surprised that we didn’t show that progesterone prevented preterm birth, and we became concerned that perhaps our cutoff of 34 weeks was just the wrong time to choose a cutoff,” Dr. Norman said, noting that a post hoc survival curve analysis was performed to look at the trajectory to delivery, and a “very marginal benefit” was seen with progesterone, but the difference was not statistically significant.
In addition, subgroup analyses showed no significant benefit of progesterone on obstetrical, neonatal, or childhood outcomes. For example, in women with a short cervix, no evidence was seen that progesterone was more or less effective than in women with a longer cervix. Other subgroups studied included fibronectin-positive and fibronectin-negative women and women with a history of preterm birth. Progesterone was no more or less effective in any of the subgroups, Dr. Norman said.
OPPTIMUM study subjects were women at risk of preterm birth because of a positive fetal fibronectin test result, a history of spontaneous preterm birth at or before 34 weeks’ gestation, or a short cervix (25 mm or less).
All outcomes were adjusted for a previous pregnancy of 14 weeks’ gestation or greater, with study center as a random effect.
“OPPTIMUM is the largest trial of progesterone to prevent preterm birth, and after adjusting for multiple comparisons as we planned, we did not disprove the null hypothesis that progesterone doesn’t prevent preterm birth, it doesn’t reduce adverse neonatal outcomes, and it doesn’t have a beneficial effect on childhood outcomes,” Dr. Norman said, concluding that “there is a remaining unmet need for a safe and effective agent to prevent preterm birth.”
Asked about the safety of progesterone given the findings from secondary analyses in OPPTIMUM, she said, “I would not advise my daughter to take progesterone if she’s pregnant.”
The study drug and placebo were donated by Besins, but the company was not involved in study design or analysis. Funding was provided by the Medical Research Council. Dr. Norman reported having no relevant financial disclosures.
ATLANTA – Vaginal progesterone confers no obstetrical or neonatal benefit, and no long-term benefit with respect to cognitive and neurosensory outcomes in children when used to prevent preterm birth, according to findings from the randomized, controlled, double-blind OPPTIMUM trial.
The findings from OPPTIMUM – the largest trial to date looking at progesterone for the prevention of preterm birth – have important implications for current practice. Vaginal progesterone is not currently approved for the prevention of preterm birth in the United States, but is commonly used off label for this purpose.
Prior studies have demonstrated a benefit with respect to progesterone for the prevention of preterm birth, particularly in women with a short cervix, but no studies have looked at long-term outcomes, Dr. Jane E. Norman of the University of Edinburgh reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
In OPPTIMUM, the rate of the primary obstetric outcome of preterm birth or fetal death before 34 weeks’ gestation did not differ significantly for 618 women at risk for preterm birth who were randomized to receive 200 mg of vaginal progesterone daily starting at 22-24 weeks and continuing to 34 weeks’ gestation, compared with 600 women who received placebo (16% vs. 18%; odds ratio, 0.86), Dr. Norman said.
The rate of the primary neonatal composite outcome of death or major morbidity (brain injury or bronchopulmonary dysplasia) also did not differ significantly between the progesterone and placebo groups after a prespecified multiple comparisons procedure (6% vs. 10%; odds ratio, 0.62).
A secondary analysis looking at the individual components of the composite neonatal outcomes showed that progesterone reduced the risk of brain injury and neonatal death, but not bronchopulmonary dysplasia, she said.
Further, no difference was seen in Bayley III cognitive scores (with values imputed for deaths) at 2 years of age in 439 and 430 children born to mothers in the progesterone and placebo groups, respectively (average scores, 97.7 and 97.3; odds ratio, 0.48).
On secondary analyses, some safety signals were noted with respect to neurodevelopmental outcomes.
“We were really surprised that we didn’t show that progesterone prevented preterm birth, and we became concerned that perhaps our cutoff of 34 weeks was just the wrong time to choose a cutoff,” Dr. Norman said, noting that a post hoc survival curve analysis was performed to look at the trajectory to delivery, and a “very marginal benefit” was seen with progesterone, but the difference was not statistically significant.
In addition, subgroup analyses showed no significant benefit of progesterone on obstetrical, neonatal, or childhood outcomes. For example, in women with a short cervix, no evidence was seen that progesterone was more or less effective than in women with a longer cervix. Other subgroups studied included fibronectin-positive and fibronectin-negative women and women with a history of preterm birth. Progesterone was no more or less effective in any of the subgroups, Dr. Norman said.
OPPTIMUM study subjects were women at risk of preterm birth because of a positive fetal fibronectin test result, a history of spontaneous preterm birth at or before 34 weeks’ gestation, or a short cervix (25 mm or less).
All outcomes were adjusted for a previous pregnancy of 14 weeks’ gestation or greater, with study center as a random effect.
“OPPTIMUM is the largest trial of progesterone to prevent preterm birth, and after adjusting for multiple comparisons as we planned, we did not disprove the null hypothesis that progesterone doesn’t prevent preterm birth, it doesn’t reduce adverse neonatal outcomes, and it doesn’t have a beneficial effect on childhood outcomes,” Dr. Norman said, concluding that “there is a remaining unmet need for a safe and effective agent to prevent preterm birth.”
Asked about the safety of progesterone given the findings from secondary analyses in OPPTIMUM, she said, “I would not advise my daughter to take progesterone if she’s pregnant.”
The study drug and placebo were donated by Besins, but the company was not involved in study design or analysis. Funding was provided by the Medical Research Council. Dr. Norman reported having no relevant financial disclosures.
AT THE PREGNANCY MEETING
Key clinical point: Vaginal progesterone had no obstetrical or neonatal benefit when used to prevent preterm birth.
Major finding: The rate of preterm birth or fetal death before 34 weeks’ gestation did not differ significantly in women treated with vaginal progesterone and those who received placebo (16% vs. 18%; odds ratio, 0.86).
Data source: The randomized, double-blind, placebo-controlled multicenter OPPTIMUM trial.
Disclosures: The study drug and placebo were donated by Besins, but the company was not involved in study design or analysis. Funding was provided by the Medical Research Council. Dr. Norman reported having no relevant financial disclosures.
Congo Red Dot Point-of-care Test Detects Preeclampsia
ATLANTA – A novel, noninvasive, “red dye on paper” diagnostic test allows for rapid screening and identification of preeclampsia at the point of care, according to findings from a prospective clinical study.
Of 343 women enrolled consecutively from a labor and delivery triage unit, 112 had a clinical diagnosis of preeclampsia. The diagnostic test – the Congo Red Dot (CRD) paper test – had an 86% rate of accuracy for detecting preeclampsia, which was superior to several other biochemical tests that were also evaluated, Dr. Kara Rood reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Among the comparator tests, which were conducted using stored urine samples to strengthen the final diagnosis, were the laboratory “gold standard” CRD nitrocellulose test, as well as Protein/Creatinine ratio, and urine and serum placental growth factor (PlGF), sFlt-1, and urine sFlt-1/PlGF (uFP) ratio. Accuracy rates ranged from 60% to 83%, said Dr. Rood, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus.
The CRD point-of-care test was developed by researchers at Ohio State and Nationwide Children’s Hospital, also in Columbus, in an effort to reduce morbidity among expecting mothers and their unborn children. The current study is the first to test the affordable tool, and the findings promise to have an important impact on the health of women and children, she said.
Study subjects were consecutive women evaluated for preeclampsia at Wexner Medical Center. The CRD test was performed using 0.45 cc of fresh crude urine, and results were scored by trained clinical nurses at the bedside.
The average latency period between a positive paper-based CRD test and delivery was 14 days, which was significantly shorter than the interval for those who tested negative, Dr. Rood said.
The CRD test was developed based on previous findings by Dr. Irina A. Buhimschi of the Center for Perinatal Research in the the Research Institute at Nationwide Children’s Hospital and her colleagues, who discovered that preeclampsia may result from a collection of misfolded proteins that are identifiable in the urine of pregnant women. Congo Red is a dye used by pathologists to identify amyloid plaques in the brains of patients with Alzheimer’s disease, and it was found to bind and incorporate into the abnormally folded proteins in the urine of pregnant women with preeclampsia. The initial CRD test for preeclampsia had an 89% accuracy rate, according to preliminary findings published in 2014.
“This new point-of-care test is a more user-friendly version than the one in the [2014] publication, and can help identify preeclampsia even before clinical symptoms appear,” Dr. Buhimschi said in a press statement, which also noted that the research team is “currently investigating how each misfolded protein collection affects pregnant women. The answer might assist with developing an effective treatment or even preventing preeclampsia.”
Dr. Rood disclosed that concepts outlined during her presentation are the subject of patents and patent applications filed by Yale University and licensed to private entities for development and commercialization. Some of the study authors are named as inventors of the Congo Red Dot test.
ATLANTA – A novel, noninvasive, “red dye on paper” diagnostic test allows for rapid screening and identification of preeclampsia at the point of care, according to findings from a prospective clinical study.
Of 343 women enrolled consecutively from a labor and delivery triage unit, 112 had a clinical diagnosis of preeclampsia. The diagnostic test – the Congo Red Dot (CRD) paper test – had an 86% rate of accuracy for detecting preeclampsia, which was superior to several other biochemical tests that were also evaluated, Dr. Kara Rood reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Among the comparator tests, which were conducted using stored urine samples to strengthen the final diagnosis, were the laboratory “gold standard” CRD nitrocellulose test, as well as Protein/Creatinine ratio, and urine and serum placental growth factor (PlGF), sFlt-1, and urine sFlt-1/PlGF (uFP) ratio. Accuracy rates ranged from 60% to 83%, said Dr. Rood, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus.
The CRD point-of-care test was developed by researchers at Ohio State and Nationwide Children’s Hospital, also in Columbus, in an effort to reduce morbidity among expecting mothers and their unborn children. The current study is the first to test the affordable tool, and the findings promise to have an important impact on the health of women and children, she said.
Study subjects were consecutive women evaluated for preeclampsia at Wexner Medical Center. The CRD test was performed using 0.45 cc of fresh crude urine, and results were scored by trained clinical nurses at the bedside.
The average latency period between a positive paper-based CRD test and delivery was 14 days, which was significantly shorter than the interval for those who tested negative, Dr. Rood said.
The CRD test was developed based on previous findings by Dr. Irina A. Buhimschi of the Center for Perinatal Research in the the Research Institute at Nationwide Children’s Hospital and her colleagues, who discovered that preeclampsia may result from a collection of misfolded proteins that are identifiable in the urine of pregnant women. Congo Red is a dye used by pathologists to identify amyloid plaques in the brains of patients with Alzheimer’s disease, and it was found to bind and incorporate into the abnormally folded proteins in the urine of pregnant women with preeclampsia. The initial CRD test for preeclampsia had an 89% accuracy rate, according to preliminary findings published in 2014.
“This new point-of-care test is a more user-friendly version than the one in the [2014] publication, and can help identify preeclampsia even before clinical symptoms appear,” Dr. Buhimschi said in a press statement, which also noted that the research team is “currently investigating how each misfolded protein collection affects pregnant women. The answer might assist with developing an effective treatment or even preventing preeclampsia.”
Dr. Rood disclosed that concepts outlined during her presentation are the subject of patents and patent applications filed by Yale University and licensed to private entities for development and commercialization. Some of the study authors are named as inventors of the Congo Red Dot test.
ATLANTA – A novel, noninvasive, “red dye on paper” diagnostic test allows for rapid screening and identification of preeclampsia at the point of care, according to findings from a prospective clinical study.
Of 343 women enrolled consecutively from a labor and delivery triage unit, 112 had a clinical diagnosis of preeclampsia. The diagnostic test – the Congo Red Dot (CRD) paper test – had an 86% rate of accuracy for detecting preeclampsia, which was superior to several other biochemical tests that were also evaluated, Dr. Kara Rood reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Among the comparator tests, which were conducted using stored urine samples to strengthen the final diagnosis, were the laboratory “gold standard” CRD nitrocellulose test, as well as Protein/Creatinine ratio, and urine and serum placental growth factor (PlGF), sFlt-1, and urine sFlt-1/PlGF (uFP) ratio. Accuracy rates ranged from 60% to 83%, said Dr. Rood, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus.
The CRD point-of-care test was developed by researchers at Ohio State and Nationwide Children’s Hospital, also in Columbus, in an effort to reduce morbidity among expecting mothers and their unborn children. The current study is the first to test the affordable tool, and the findings promise to have an important impact on the health of women and children, she said.
Study subjects were consecutive women evaluated for preeclampsia at Wexner Medical Center. The CRD test was performed using 0.45 cc of fresh crude urine, and results were scored by trained clinical nurses at the bedside.
The average latency period between a positive paper-based CRD test and delivery was 14 days, which was significantly shorter than the interval for those who tested negative, Dr. Rood said.
The CRD test was developed based on previous findings by Dr. Irina A. Buhimschi of the Center for Perinatal Research in the the Research Institute at Nationwide Children’s Hospital and her colleagues, who discovered that preeclampsia may result from a collection of misfolded proteins that are identifiable in the urine of pregnant women. Congo Red is a dye used by pathologists to identify amyloid plaques in the brains of patients with Alzheimer’s disease, and it was found to bind and incorporate into the abnormally folded proteins in the urine of pregnant women with preeclampsia. The initial CRD test for preeclampsia had an 89% accuracy rate, according to preliminary findings published in 2014.
“This new point-of-care test is a more user-friendly version than the one in the [2014] publication, and can help identify preeclampsia even before clinical symptoms appear,” Dr. Buhimschi said in a press statement, which also noted that the research team is “currently investigating how each misfolded protein collection affects pregnant women. The answer might assist with developing an effective treatment or even preventing preeclampsia.”
Dr. Rood disclosed that concepts outlined during her presentation are the subject of patents and patent applications filed by Yale University and licensed to private entities for development and commercialization. Some of the study authors are named as inventors of the Congo Red Dot test.
AT THE PREGNANCY MEETING
Congo Red Dot point-of-care test detects preeclampsia
ATLANTA – A novel, noninvasive, “red dye on paper” diagnostic test allows for rapid screening and identification of preeclampsia at the point of care, according to findings from a prospective clinical study.
Of 343 women enrolled consecutively from a labor and delivery triage unit, 112 had a clinical diagnosis of preeclampsia. The diagnostic test – the Congo Red Dot (CRD) paper test – had an 86% rate of accuracy for detecting preeclampsia, which was superior to several other biochemical tests that were also evaluated, Dr. Kara Rood reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Among the comparator tests, which were conducted using stored urine samples to strengthen the final diagnosis, were the laboratory “gold standard” CRD nitrocellulose test, as well as Protein/Creatinine ratio, and urine and serum placental growth factor (PlGF), sFlt-1, and urine sFlt-1/PlGF (uFP) ratio. Accuracy rates ranged from 60% to 83%, said Dr. Rood, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus.
The CRD point-of-care test was developed by researchers at Ohio State and Nationwide Children’s Hospital, also in Columbus, in an effort to reduce morbidity among expecting mothers and their unborn children. The current study is the first to test the affordable tool, and the findings promise to have an important impact on the health of women and children, she said.
Study subjects were consecutive women evaluated for preeclampsia at Wexner Medical Center. The CRD test was performed using 0.45 cc of fresh crude urine, and results were scored by trained clinical nurses at the bedside.
The average latency period between a positive paper-based CRD test and delivery was 14 days, which was significantly shorter than the interval for those who tested negative, Dr. Rood said.
The CRD test was developed based on previous findings by Dr. Irina A. Buhimschi of the Center for Perinatal Research in the the Research Institute at Nationwide Children’s Hospital and her colleagues, who discovered that preeclampsia may result from a collection of misfolded proteins that are identifiable in the urine of pregnant women. Congo Red is a dye used by pathologists to identify amyloid plaques in the brains of patients with Alzheimer’s disease, and it was found to bind and incorporate into the abnormally folded proteins in the urine of pregnant women with preeclampsia. The initial CRD test for preeclampsia had an 89% accuracy rate, according to preliminary findings published in 2014.
“This new point-of-care test is a more user-friendly version than the one in the [2014] publication, and can help identify preeclampsia even before clinical symptoms appear,” Dr. Buhimschi said in a press statement, which also noted that the research team is “currently investigating how each misfolded protein collection affects pregnant women. The answer might assist with developing an effective treatment or even preventing preeclampsia.”
Dr. Rood disclosed that concepts outlined during her presentation are the subject of patents and patent applications filed by Yale University and licensed to private entities for development and commercialization. Some of the study authors are named as inventors of the Congo Red Dot test.
ATLANTA – A novel, noninvasive, “red dye on paper” diagnostic test allows for rapid screening and identification of preeclampsia at the point of care, according to findings from a prospective clinical study.
Of 343 women enrolled consecutively from a labor and delivery triage unit, 112 had a clinical diagnosis of preeclampsia. The diagnostic test – the Congo Red Dot (CRD) paper test – had an 86% rate of accuracy for detecting preeclampsia, which was superior to several other biochemical tests that were also evaluated, Dr. Kara Rood reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Among the comparator tests, which were conducted using stored urine samples to strengthen the final diagnosis, were the laboratory “gold standard” CRD nitrocellulose test, as well as Protein/Creatinine ratio, and urine and serum placental growth factor (PlGF), sFlt-1, and urine sFlt-1/PlGF (uFP) ratio. Accuracy rates ranged from 60% to 83%, said Dr. Rood, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus.
The CRD point-of-care test was developed by researchers at Ohio State and Nationwide Children’s Hospital, also in Columbus, in an effort to reduce morbidity among expecting mothers and their unborn children. The current study is the first to test the affordable tool, and the findings promise to have an important impact on the health of women and children, she said.
Study subjects were consecutive women evaluated for preeclampsia at Wexner Medical Center. The CRD test was performed using 0.45 cc of fresh crude urine, and results were scored by trained clinical nurses at the bedside.
The average latency period between a positive paper-based CRD test and delivery was 14 days, which was significantly shorter than the interval for those who tested negative, Dr. Rood said.
The CRD test was developed based on previous findings by Dr. Irina A. Buhimschi of the Center for Perinatal Research in the the Research Institute at Nationwide Children’s Hospital and her colleagues, who discovered that preeclampsia may result from a collection of misfolded proteins that are identifiable in the urine of pregnant women. Congo Red is a dye used by pathologists to identify amyloid plaques in the brains of patients with Alzheimer’s disease, and it was found to bind and incorporate into the abnormally folded proteins in the urine of pregnant women with preeclampsia. The initial CRD test for preeclampsia had an 89% accuracy rate, according to preliminary findings published in 2014.
“This new point-of-care test is a more user-friendly version than the one in the [2014] publication, and can help identify preeclampsia even before clinical symptoms appear,” Dr. Buhimschi said in a press statement, which also noted that the research team is “currently investigating how each misfolded protein collection affects pregnant women. The answer might assist with developing an effective treatment or even preventing preeclampsia.”
Dr. Rood disclosed that concepts outlined during her presentation are the subject of patents and patent applications filed by Yale University and licensed to private entities for development and commercialization. Some of the study authors are named as inventors of the Congo Red Dot test.
ATLANTA – A novel, noninvasive, “red dye on paper” diagnostic test allows for rapid screening and identification of preeclampsia at the point of care, according to findings from a prospective clinical study.
Of 343 women enrolled consecutively from a labor and delivery triage unit, 112 had a clinical diagnosis of preeclampsia. The diagnostic test – the Congo Red Dot (CRD) paper test – had an 86% rate of accuracy for detecting preeclampsia, which was superior to several other biochemical tests that were also evaluated, Dr. Kara Rood reported at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Among the comparator tests, which were conducted using stored urine samples to strengthen the final diagnosis, were the laboratory “gold standard” CRD nitrocellulose test, as well as Protein/Creatinine ratio, and urine and serum placental growth factor (PlGF), sFlt-1, and urine sFlt-1/PlGF (uFP) ratio. Accuracy rates ranged from 60% to 83%, said Dr. Rood, a maternal-fetal medicine fellow at the Ohio State University Wexner Medical Center, Columbus.
The CRD point-of-care test was developed by researchers at Ohio State and Nationwide Children’s Hospital, also in Columbus, in an effort to reduce morbidity among expecting mothers and their unborn children. The current study is the first to test the affordable tool, and the findings promise to have an important impact on the health of women and children, she said.
Study subjects were consecutive women evaluated for preeclampsia at Wexner Medical Center. The CRD test was performed using 0.45 cc of fresh crude urine, and results were scored by trained clinical nurses at the bedside.
The average latency period between a positive paper-based CRD test and delivery was 14 days, which was significantly shorter than the interval for those who tested negative, Dr. Rood said.
The CRD test was developed based on previous findings by Dr. Irina A. Buhimschi of the Center for Perinatal Research in the the Research Institute at Nationwide Children’s Hospital and her colleagues, who discovered that preeclampsia may result from a collection of misfolded proteins that are identifiable in the urine of pregnant women. Congo Red is a dye used by pathologists to identify amyloid plaques in the brains of patients with Alzheimer’s disease, and it was found to bind and incorporate into the abnormally folded proteins in the urine of pregnant women with preeclampsia. The initial CRD test for preeclampsia had an 89% accuracy rate, according to preliminary findings published in 2014.
“This new point-of-care test is a more user-friendly version than the one in the [2014] publication, and can help identify preeclampsia even before clinical symptoms appear,” Dr. Buhimschi said in a press statement, which also noted that the research team is “currently investigating how each misfolded protein collection affects pregnant women. The answer might assist with developing an effective treatment or even preventing preeclampsia.”
Dr. Rood disclosed that concepts outlined during her presentation are the subject of patents and patent applications filed by Yale University and licensed to private entities for development and commercialization. Some of the study authors are named as inventors of the Congo Red Dot test.
AT THE PREGNANCY MEETING
Key clinical point: A noninvasive, “red dye on paper” diagnostic test was effective for rapid screening of preeclampsia.
Major finding: The Congo Red Dot (CRD) paper test had an 86% rate of accuracy for detecting preeclampsia.
Data source: A prospective clinical study of 343 women.
Disclosures: Dr. Rood disclosed that concepts outlined during her presentation are the subject of patents and patent applications filed by Yale University and licensed to private entities for development and commercialization. Some of the study authors are named as inventors of the Congo Red Dot test.
