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Maternal antidepressants unrelated to autism in offspring
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
These two studies add to the growing literature suggesting that any association between prenatal antidepressant exposure and autism spectrum disorder may not be causal.
Both reports should reassure both parents and clinicians.
And regardless of whether any such association reflects antidepressant effects, the mother’s underlying mental health, or other factors, efforts should focus on promoting optimal child health in ways that harness the child’s inherent developmental plasticity.
Tim F. Oberlander, MD, is in the division of developmental pediatrics at the University of British Columbia and at the British Columbia Children’s Hospital Research Institute, both in Vancouver. Lonnie Zwaigenbaum, MD, is in the department of pediatrics at the University of Alberta, Edmonton. They reported having no relevant financial disclosures. These remarks were excerpted from an editorial accompanying the two reports (JAMA. 2017;317[15]:1533-4).
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in the offspring, according to two separate, population-level cohort studies that used sophisticated statistical techniques to account for numerous confounding factors.
Both studies were reported online April 18 in JAMA.
Some previous studies have reported a possible link between in utero exposure to antidepressants, particularly SSRIs, and autism. But they had limited ability to control for key confounders, notably the mother’s underlying depression.
Overall, 1.1% of these children were diagnosed as having autism spectrum disorder. This prevalence is consistent with current population estimates, indicating that few if any cases of the disorder were missed, said Dr. Brown of Women’s College Research Institute in Toronto and the division of epidemiology, University of Toronto, and her associates.
In initial, unadjusted analyses of the data, the risk of autism was higher in exposed than in nonexposed children. However, that association disappeared once the data were adjusted to account for numerous potential confounders.
Further analysis comparing the exposed children with their unexposed siblings also found that after adjusting for confounding factors, prenatal exposure to antidepressants did not affect the risk of developing autism. In addition, this lack of association also was found in the subgroup of children whose mothers took antidepressants shortly before but not during pregnancy.
Taken together, these findings “suggest that confounding by indication for the medication may explain previously observed associations between in utero serotonergic antidepressant exposure and autism spectrum disorder,” Dr. Brown and her associates said (JAMA. 2017 Apr 18. doi: 10.1001.jama.2017.3415). In the other study, Ayesha C. Sujan and her associates analyzed data in several nationwide Swedish registries to examine whether first trimester exposure to any antidepressants raised the risk of a range of neurodevelopmental problems, including autism. This study involved 1,580,629 offspring, including 22,544 (1.4%) whose mothers took antidepressants during the first trimester.
As with Dr. Brown’s study, the initial unadjusted analysis showed an association between antidepressant exposure and autism, but that association disappeared once the data were adjusted to account for confounding factors. In the final data analysis, first trimester exposure was associated with preterm birth (odds ratio, 1.34) but not with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (hazard ratio, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99), said Ms. Sujan of the department of psychological and brain sciences, Indiana University, Bloomington, and her associates.
“These results are consistent with the hypothesis that genetic factors, familial environmental factors, or both, account for the population-wide associations between first-trimester antidepressant exposure and these outcomes,” they noted (JAMA. 2017 Apr 18. doi: 10.1001/jama.2017.3413).
FROM JAMA
Key clinical point: Maternal use of antidepressants during pregnancy is unrelated to autism spectrum disorder in offspring.
Major finding: Prenatal exposure to antidepressants was not associated with small-for-gestational-age size (OR, 1.01), autism spectrum disorder (HR, 0.83), or attention deficit/hyperactivity disorder (HR, 0.99).
Data source: Two separate retrospective cohort studies involving 35,906 births in Canada and 1,580,629 in Sweden.
Disclosures: Dr. Brown’s study was supported by the Institute for Clinical Evaluative Sciences and the Ontario Ministry of Health and Long-Term Care. Dr. Brown and her associates reported having no relevant financial disclosures. Dr. Sujan’s study was supported by the U.S. National Institute of Mental Health, the National Institute on Drug Abuse, the National Science Foundation, and others. Dr. Sujan reported having no relevant financial disclosures; her associates reported ties to numerous industry sources.
Universal preterm birth screening not ready for prime time
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
FROM JAMA
Key clinical point:
Major finding: With a threshold of transvaginal cervical length of 25 mm or less at 16-22 weeks’ gestation, 247 women would need to be screened to identify one case of spontaneous preterm birth before 37 weeks’ gestation.
Data source: A prospective multicenter observational cohort study involving 9,410 nulliparous women across the United States.
Disclosures: The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. An associate reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
Maternal vitamin E isoform levels possible marker for infant wheezing risk
ATLANTA – Increasing maternal postpartum–plasma alpha-tocopherol isoform concentration was associated with a decreased likelihood of wheezing at age 2 years, defined as wheezing in the past 12 months, use of asthma medications in the past 12 months, or diagnosis of asthma, results from a large analysis showed.
“For now, this is an association and not causation,” study author Cosby Stone, MD, MPH, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “We need a clinical trial to evaluate the effect of giving more alpha-tocopherol to mothers during pregnancy before anyone should jump to giving supplements.”
The median age of children at the time of maternal sample collection was 50 days. 47% were female, and 61% were white. Of the 652 children, 167 (26%) met criteria for wheezing at age 2 years. These children had mothers with significantly lower postpartum concentrations of plasma alpha-tocopherol, compared with those who did not meet criteria for wheezing at 2 years (a mean of 69 micromol/L vs. 75 micromol/L, respectively; P = .02). In multivariable regression analysis, the researchers detected a significant interaction between gamma-tocopherol and alpha-tocopherol, where the highest amounts of maternal gamma-tocopherol modified and mitigated the protective association of maternal alpha-tocopherol with risk of wheezing at 2 years (P = .05).
Dr. Stone cautioned that, what is currently labeled as vitamin E or alpha-tocopherol in foods and supplements, “could be any of eight different isoforms, and alpha-tocopherol may not actually be the dominant isoform being provided. In addition, the oils that we eat are the main sources of tocopherols in our diet, and they vary widely in terms of their tocopherol isoforms. Sunflower and safflower oil, for example, provide predominantly alpha-tocopherol as their isoform of vitamin E, while corn and soy oil provide predominantly gamma-tocopherol.”
For now, he continued, correcting maternal alpha-tocopherol deficiency, currently defined by a serum alpha-tocopherol concentration less than 11.6 micromol/L, is certainly reasonable. Down the road, modification of maternal alpha-tocopherol or gamma-tocopherol concentrations through dietary counseling may provide clinicians with a tool to prevent wheezing or asthma in affected children. “In the future there may be a role for checking tocopherol isoforms in pregnant women and then modifying dietary oil consumption to protect the health of their children,” he said.
He acknowledged certain limitations of the study, including that researchers obtained maternal vitamin E isoform measurements at enrollment, when the infants were, on average, 6 weeks post partum, and not during pregnancy. “However, the literature has shown that postpartum vitamin E levels at this time point are very similar to those during the second trimester of pregnancy,” Dr. Stone said. “The literature has also shown that plasma vitamin E isoform concentrations are tightly tied to diet and body stores and do not change very rapidly (such that a woman would not be likely to go from the highest quartile to the lowest, or vice versa). People’s diets don’t tend to change that much, in general.”
INSPIRE is funded by the National Institutes of Health. Dr. Stone is funded by an NIH training grant through Vanderbilt University. He reported having no relevant financial disclosures.
ATLANTA – Increasing maternal postpartum–plasma alpha-tocopherol isoform concentration was associated with a decreased likelihood of wheezing at age 2 years, defined as wheezing in the past 12 months, use of asthma medications in the past 12 months, or diagnosis of asthma, results from a large analysis showed.
“For now, this is an association and not causation,” study author Cosby Stone, MD, MPH, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “We need a clinical trial to evaluate the effect of giving more alpha-tocopherol to mothers during pregnancy before anyone should jump to giving supplements.”
The median age of children at the time of maternal sample collection was 50 days. 47% were female, and 61% were white. Of the 652 children, 167 (26%) met criteria for wheezing at age 2 years. These children had mothers with significantly lower postpartum concentrations of plasma alpha-tocopherol, compared with those who did not meet criteria for wheezing at 2 years (a mean of 69 micromol/L vs. 75 micromol/L, respectively; P = .02). In multivariable regression analysis, the researchers detected a significant interaction between gamma-tocopherol and alpha-tocopherol, where the highest amounts of maternal gamma-tocopherol modified and mitigated the protective association of maternal alpha-tocopherol with risk of wheezing at 2 years (P = .05).
Dr. Stone cautioned that, what is currently labeled as vitamin E or alpha-tocopherol in foods and supplements, “could be any of eight different isoforms, and alpha-tocopherol may not actually be the dominant isoform being provided. In addition, the oils that we eat are the main sources of tocopherols in our diet, and they vary widely in terms of their tocopherol isoforms. Sunflower and safflower oil, for example, provide predominantly alpha-tocopherol as their isoform of vitamin E, while corn and soy oil provide predominantly gamma-tocopherol.”
For now, he continued, correcting maternal alpha-tocopherol deficiency, currently defined by a serum alpha-tocopherol concentration less than 11.6 micromol/L, is certainly reasonable. Down the road, modification of maternal alpha-tocopherol or gamma-tocopherol concentrations through dietary counseling may provide clinicians with a tool to prevent wheezing or asthma in affected children. “In the future there may be a role for checking tocopherol isoforms in pregnant women and then modifying dietary oil consumption to protect the health of their children,” he said.
He acknowledged certain limitations of the study, including that researchers obtained maternal vitamin E isoform measurements at enrollment, when the infants were, on average, 6 weeks post partum, and not during pregnancy. “However, the literature has shown that postpartum vitamin E levels at this time point are very similar to those during the second trimester of pregnancy,” Dr. Stone said. “The literature has also shown that plasma vitamin E isoform concentrations are tightly tied to diet and body stores and do not change very rapidly (such that a woman would not be likely to go from the highest quartile to the lowest, or vice versa). People’s diets don’t tend to change that much, in general.”
INSPIRE is funded by the National Institutes of Health. Dr. Stone is funded by an NIH training grant through Vanderbilt University. He reported having no relevant financial disclosures.
ATLANTA – Increasing maternal postpartum–plasma alpha-tocopherol isoform concentration was associated with a decreased likelihood of wheezing at age 2 years, defined as wheezing in the past 12 months, use of asthma medications in the past 12 months, or diagnosis of asthma, results from a large analysis showed.
“For now, this is an association and not causation,” study author Cosby Stone, MD, MPH, said in an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “We need a clinical trial to evaluate the effect of giving more alpha-tocopherol to mothers during pregnancy before anyone should jump to giving supplements.”
The median age of children at the time of maternal sample collection was 50 days. 47% were female, and 61% were white. Of the 652 children, 167 (26%) met criteria for wheezing at age 2 years. These children had mothers with significantly lower postpartum concentrations of plasma alpha-tocopherol, compared with those who did not meet criteria for wheezing at 2 years (a mean of 69 micromol/L vs. 75 micromol/L, respectively; P = .02). In multivariable regression analysis, the researchers detected a significant interaction between gamma-tocopherol and alpha-tocopherol, where the highest amounts of maternal gamma-tocopherol modified and mitigated the protective association of maternal alpha-tocopherol with risk of wheezing at 2 years (P = .05).
Dr. Stone cautioned that, what is currently labeled as vitamin E or alpha-tocopherol in foods and supplements, “could be any of eight different isoforms, and alpha-tocopherol may not actually be the dominant isoform being provided. In addition, the oils that we eat are the main sources of tocopherols in our diet, and they vary widely in terms of their tocopherol isoforms. Sunflower and safflower oil, for example, provide predominantly alpha-tocopherol as their isoform of vitamin E, while corn and soy oil provide predominantly gamma-tocopherol.”
For now, he continued, correcting maternal alpha-tocopherol deficiency, currently defined by a serum alpha-tocopherol concentration less than 11.6 micromol/L, is certainly reasonable. Down the road, modification of maternal alpha-tocopherol or gamma-tocopherol concentrations through dietary counseling may provide clinicians with a tool to prevent wheezing or asthma in affected children. “In the future there may be a role for checking tocopherol isoforms in pregnant women and then modifying dietary oil consumption to protect the health of their children,” he said.
He acknowledged certain limitations of the study, including that researchers obtained maternal vitamin E isoform measurements at enrollment, when the infants were, on average, 6 weeks post partum, and not during pregnancy. “However, the literature has shown that postpartum vitamin E levels at this time point are very similar to those during the second trimester of pregnancy,” Dr. Stone said. “The literature has also shown that plasma vitamin E isoform concentrations are tightly tied to diet and body stores and do not change very rapidly (such that a woman would not be likely to go from the highest quartile to the lowest, or vice versa). People’s diets don’t tend to change that much, in general.”
INSPIRE is funded by the National Institutes of Health. Dr. Stone is funded by an NIH training grant through Vanderbilt University. He reported having no relevant financial disclosures.
AT THE 2017 AAAAI ANNUAL MEETING
Key clinical point:
Major finding: Increasing maternal postpartum–plasma alpha-tocopherol concentration was associated with a decreased likelihood of wheezing requiring asthma medications at 2 years (P = .02).
Data source: A prospective evaluation of 652 children with maternal postpartum–plasma vitamin E isoforms measured at study enrollment.
Disclosures: INSPIRE is funded by the National Institutes of Health. Dr. Stone is funded by an NIH training grant through Vanderbilt University. He reported having no relevant financial disclosures.
Pregnancy medical home reduces hospital visits, overall costs
LAS VEGAS – Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.
In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).
The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.
The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.
From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.
Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.
Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.
The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.
The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”
A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.
The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.
Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.
[email protected]
On Twitter @karioakes
LAS VEGAS – Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.
In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).
The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.
The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.
From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.
Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.
Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.
The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.
The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”
A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.
The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.
Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.
[email protected]
On Twitter @karioakes
LAS VEGAS – Women and their newborns who received care through a pregnancy medical home model used the emergency department less and had fewer inpatient stays, resulting in significant cost savings to a state health insurance plan.
In the single-center, retrospective cohort study, women who had at least one medical home visit had 897 emergency department visits per 1,000 member months, compared with 1,969/1,000 member months for patients who had no medical home visits (P less than .01). Newborns in the medical home group had fewer inpatient days per 1,000 member months as well, compared with non–medical home infants (698 vs. 1,799 days/member month, P less than .01). Inpatient stays for pregnant women receiving medical home care were also reduced (4,279 vs. 2,939 inpatient days, P less than .01).
The pregnancy medical home project was conducted jointly by the Texas Children’s Health Plan and Baylor College of Medicine. The care delivery model, offered from the Baylor Center for Children and Women, gave pregnant women enhanced access, used evidence-based protocols for treatment, and emphasized both quality care and the patient experience, said Dr. Suhag, professor of ob.gyn. at Baylor College of Medicine, Houston.
The pregnancy medical home includes extended hours, walk-in appointments, 24-hour nurse availability for triage, and a laborist model for hospital coverage.
From a payment perspective, the medical home is a fully capitated, full-risk model. “Our center is paid on a monthly basis to provide care to members of our panel,” Dr. Suhag said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The primary outcomes measured by the study were the number of inpatient days and the rate of emergency department usage among pregnancy medical home participants, compared with nonparticipating pregnant women and newborns seen at the Center for Children and Women. Annualized cost savings for the pregnancy medical home model was a secondary outcome measure.
Over a 1-year period, the study examined claims data for pregnant women and newborns who were enrolled in the Texas Children’s Health Plan and were assigned to the pregnancy medical home panel. In total, 27,912 member months (including care for both women and newborns) were examined; of these, about 37% (10,402) were for women and newborns who had at least one medical home visit, and 63% (17,510) of the member months accrued to patients who had no medical home visits. Women and their infants were excluded from the cohort if they received care billed to another health plan.
Participation in the medical home group resulted in lower costs, with annualized estimated emergency department cost savings of $330,161 and $30,739 for pregnant women and newborns, respectively. The reduced number of inpatient days in the medical home group resulted in a total savings of $494,313 for pregnant women and $1,606,392 for newborns in this cohort.
The integrated care model, which used a care coordinator and provided care from multiple specialties at a single site, was likely the key to success, Dr. Suhag said. “With this access, 40% of our pregnant moms were able to access prenatal care in the first trimester, which likely improved outcomes and contributed to the cost savings,” she said.
The control group in the study was made up of individuals who had been randomized to the medical home, but who had chosen care from another provider instead. Because the researchers were relying on health claims data, they were not able to perform a detailed comparison between the two groups, leaving open the possibility that patient characteristics may have accounted for part of the differences in outcomes. Women “could self-select to receive care at the Center for Children and Women,” Dr. Suhag said in an interview. “It is possible that they are different than the women who did not choose care in our clinic.”
A strength of the study, Dr. Suhag said, is that it evaluated outcomes from the medical home model by comparing it to several other medical practices caring for a similar demographic in the same geographic area.
The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.
Dr. Suhag reported having no outside sources of funding beyond the study’s two sponsoring organizations and no conflicts of interest.
[email protected]
On Twitter @karioakes
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: Medical home patients had 897 emergency department visits, compared with 1,969 per 1,000 member months for non–medical home patients (P less than .01).
Data source: A retrospective cohort study of 27,912 patient member months comparing pregnancy medical home patients with non–medical home patients.
Disclosures: The study was conducted by the Texas Children’s Health Plan and Baylor College of Medicine. Dr. Suhag reported having no other outside sources of funding or conflicts of interest.
Weekend births linked to higher maternal-fetal mortality
LAS VEGAS – Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.
“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.
Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.
In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.
On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).
A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).
Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .
Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.
“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.
For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).
Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.
The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).
Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
LAS VEGAS – Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.
“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.
Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.
In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.
On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).
A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).
Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .
Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.
“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.
For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).
Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.
The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).
Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
LAS VEGAS – Weekend deliveries were associated with a significantly increased risk of maternal-fetal morbidity and death, according to a review of all U.S. deliveries over the past decade.
“Maternal morbidity and mortality were increased on weekends, compared to weekdays, and stillbirth and neonatal morbidity were also increased in infants delivered on weekends. Both of these findings occur against a background of lower intrinsic risk among weekend deliveries,” Amirhossein Moaddab, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
Study objectives included measuring both maternal and fetal mortality ratios by the day and month of death or delivery; the study also tracked maternal and neonatal morbidities according to the day of the week the delivery occurred.
Using publicly available data sets (the National Vital Statistics System and the Centers for Disease Control and Prevention WONDER online database), Dr. Moaddab and his colleagues examined all live births and all maternal and fetal deaths in all 50 states and the District of Columbia for the period from 2004 to 2014.
In total, there were 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths during this period.
On weekdays, the maternal mortality rate was 15.3/100,000 live births; the rate rose to 22.8 maternal deaths per 100,000 live births on the weekends (P less than .001). Fetal mortality followed a similar pattern: The weekday fetal mortality rate was 5.85/1,000 live births, compared with 7.21/1,000 live births on the weekends (P less than .001).
A wide range of maternal and fetal morbidities were also more common when deliveries happened on the weekend. For mothers, the adjusted relative risk (aRR) ranged from 1.41 for maternal transfusion to 1.166 for perineal lacerations with Saturday or Sunday deliveries. Unplanned hysterectomy, however, was less likely on the weekend (aRR, 0.810).
Neonatal morbidities with a higher adjusted relative risk included gestational age less than 28 weeks (aRR, 1.481), a 5-minute Apgar score less than 7 (aRR, 1.251), and being placed on a ventilator or admitted to the neonatal intensive care unit (aRRs, 1.219 and 1.199, respectively). The odds of having a chromosomal abnormality were lower for infants delivered on weekends (aRR, 0.864), a result consistent with the increased likelihood of planned delivery for fetuses whose chromosomal status was known, said Dr. Moaddab, a postdoctoral fellow in obstetrics and gynecology at the Baylor College of Medicine, Houston .
Examining maternal characteristics, Dr. Moaddab and his colleagues did find some significant differences between those delivering on weekdays and weekends. However, because the weekend group was healthier overall than the weekday group, these differences were not likely to account for the worse weekend outcomes.
“We were able to control for pregnancy complications, and found that most women with pregnancy complications known to lead to death actually deliver on weekdays, suggesting that the total problem with weekend deliveries is even greater,” said Dr. Clark, professor of ob.gyn. at Baylor College of Medicine.
For example, women delivering on weekends were less likely to be smokers, have diabetes or gestational diabetes, or have chronic or gestational hypertension; they were also less likely to have had a previous cesarean delivery (all P equal to or less than .0001). They were, however, more likely to be nulliparous and to have eclampsia (P equal to or less than .0001).
Dr. Moaddab said that his group’s examination of monthly variations in maternal and fetal morbidity and mortality showed no sign of the “July phenomenon,” the worsening in outcomes seen in some specialties when new interns take to the wards and clinics.
The “weekend effect,” said Dr. Moaddab, has been documented elsewhere as well. In the United Kingdom, a recent observational study of obstetric outcomes found “increases in the rates of death and other complications for both women and babies born at weekends,” he said (BMJ. 2015;351:h5774).
Though Dr. Moaddab’s descriptive study couldn’t get at underlying causes, he said that there are many possible culprits. These can include the divided physician attention and reduced provider availability that can come with weekend staffing, as well as the possibility that the experience level of both physician and nurse staff drops on weekends. Long work hours that come with call may also contribute, he said.
The study authors reported no outside sources of funding and no conflicts of interest.
[email protected]
On Twitter @karioakes
AT THE PREGNANCY MEETING
Key clinical point:
Major finding: On weekends, the maternal death rate was 22.8/100,000 live births, compared with a weekday rate of 15.3/100,000 (P less than .001).
Data source: A retrospective study of U.S. publicly available maternal-fetal data, including 45,036,622 live births, 7,551 maternal deaths, and 275,914 stillbirths from 2004 to 2014.
Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.
CDC: More preterm births after fertility treatments
Infants conceived through assisted reproductive technology (ART) represented less than 2% of all children born in the United States in 2014, but they experienced disproportionately large shares of adverse perinatal outcomes, according to the Centers for Disease Control and Prevention.
Of the 4.02 million children born in the United States in 2014, a total of 65,296 (1.6%) were conceived with ART procedures. ART-conceived children, however, represented 5.5% of all low-birth-weight infants (less than 2,500 g) and 5.6% of all very-low-birth-weight infants (less than 1,500 g). ART-conceived children also represented 4.7% of all preterm births (less than 37 weeks) in 2014 and 5.0% of all very preterm (less than 32 weeks) infants nationally, the CDC reported (MMWR Surveill Summ. 2017;66[SS-6]:1-24).
These poor outcomes are related, at least in part, to the effect of infertility treatment on multiple births. The percentage of triplets or higher-order infants among ART-conceived infants has decreased since 2000, but “the percentage of twin infants has remained persistently high,” the CDC noted. Multiple-birth infants represent 39.4% of all ART infants but only 3.5% of all infants, and ART-conceived multiple-birth infants represent 18.3% of all multiple-birth infants, the CDC said.
The multiple-birth effect varied considerably by state, however. In Hawaii, ART-conceived multiple-birth infants accounted for 37.3% of all multiple births in 2014, while Alaska and West Virginia both had rates of 5.5%. Poor outcomes also varied by state: In Massachusetts, ART infants represented 14.2% of all low-birth-weight infants, compared with 1.2% in West Virginia. Massachusetts had the highest rate of ART preterm infants to all infants, 13.4%, and Puerto Rico had the lowest, 1.2%, according to the CDC report, which was based on data from the National ART Surveillance System.
Puerto Rico’s rate of 364 ART procedures per 1 million women aged 15-44 years was the lowest in the country, and the highest rate belonged to Massachusetts at 6,726 per 1 million women aged 15-44 years.
Infants conceived through assisted reproductive technology (ART) represented less than 2% of all children born in the United States in 2014, but they experienced disproportionately large shares of adverse perinatal outcomes, according to the Centers for Disease Control and Prevention.
Of the 4.02 million children born in the United States in 2014, a total of 65,296 (1.6%) were conceived with ART procedures. ART-conceived children, however, represented 5.5% of all low-birth-weight infants (less than 2,500 g) and 5.6% of all very-low-birth-weight infants (less than 1,500 g). ART-conceived children also represented 4.7% of all preterm births (less than 37 weeks) in 2014 and 5.0% of all very preterm (less than 32 weeks) infants nationally, the CDC reported (MMWR Surveill Summ. 2017;66[SS-6]:1-24).
These poor outcomes are related, at least in part, to the effect of infertility treatment on multiple births. The percentage of triplets or higher-order infants among ART-conceived infants has decreased since 2000, but “the percentage of twin infants has remained persistently high,” the CDC noted. Multiple-birth infants represent 39.4% of all ART infants but only 3.5% of all infants, and ART-conceived multiple-birth infants represent 18.3% of all multiple-birth infants, the CDC said.
The multiple-birth effect varied considerably by state, however. In Hawaii, ART-conceived multiple-birth infants accounted for 37.3% of all multiple births in 2014, while Alaska and West Virginia both had rates of 5.5%. Poor outcomes also varied by state: In Massachusetts, ART infants represented 14.2% of all low-birth-weight infants, compared with 1.2% in West Virginia. Massachusetts had the highest rate of ART preterm infants to all infants, 13.4%, and Puerto Rico had the lowest, 1.2%, according to the CDC report, which was based on data from the National ART Surveillance System.
Puerto Rico’s rate of 364 ART procedures per 1 million women aged 15-44 years was the lowest in the country, and the highest rate belonged to Massachusetts at 6,726 per 1 million women aged 15-44 years.
Infants conceived through assisted reproductive technology (ART) represented less than 2% of all children born in the United States in 2014, but they experienced disproportionately large shares of adverse perinatal outcomes, according to the Centers for Disease Control and Prevention.
Of the 4.02 million children born in the United States in 2014, a total of 65,296 (1.6%) were conceived with ART procedures. ART-conceived children, however, represented 5.5% of all low-birth-weight infants (less than 2,500 g) and 5.6% of all very-low-birth-weight infants (less than 1,500 g). ART-conceived children also represented 4.7% of all preterm births (less than 37 weeks) in 2014 and 5.0% of all very preterm (less than 32 weeks) infants nationally, the CDC reported (MMWR Surveill Summ. 2017;66[SS-6]:1-24).
These poor outcomes are related, at least in part, to the effect of infertility treatment on multiple births. The percentage of triplets or higher-order infants among ART-conceived infants has decreased since 2000, but “the percentage of twin infants has remained persistently high,” the CDC noted. Multiple-birth infants represent 39.4% of all ART infants but only 3.5% of all infants, and ART-conceived multiple-birth infants represent 18.3% of all multiple-birth infants, the CDC said.
The multiple-birth effect varied considerably by state, however. In Hawaii, ART-conceived multiple-birth infants accounted for 37.3% of all multiple births in 2014, while Alaska and West Virginia both had rates of 5.5%. Poor outcomes also varied by state: In Massachusetts, ART infants represented 14.2% of all low-birth-weight infants, compared with 1.2% in West Virginia. Massachusetts had the highest rate of ART preterm infants to all infants, 13.4%, and Puerto Rico had the lowest, 1.2%, according to the CDC report, which was based on data from the National ART Surveillance System.
Puerto Rico’s rate of 364 ART procedures per 1 million women aged 15-44 years was the lowest in the country, and the highest rate belonged to Massachusetts at 6,726 per 1 million women aged 15-44 years.
FROM MMWR SURVEILLANCE SUMMARIES
More periviable infants survive without neurodevelopmental impairment
Among periviable infants born at 11 tertiary care centers in 2000 through 2011, the rate of survival without neurodevelopmental impairment increased a small but significant 4%, according to a report published online Feb. 16 in the New England Journal of Medicine.
The rate of survival with neurodevelopmental impairment also increased, although to a lesser extent (1%).
“These findings are important for guiding counseling and decision making with respect to periviable birth. Prognosis continues to be guarded; in the most recent epoch [time period in our study], mortality was 64%, and 43% of surviving infants had neurodevelopmental impairment,” they noted.
The investigators defined such impairment as moderate or severe cerebral palsy, Gross Motor Function Classification System level of at least 2 on a scale of 1-5, profound hearing loss requiring amplification in both ears, profound visual impairment in both eyes, or cognitive impairment such as a Mental Developmental Index score of less than 70 or a Cognitive Composite score of less than 85.
To examine time trends in the outcomes of periviable infants, Dr. Younge of Duke University, Durham, N.C., and her associates analyzed data from the network’s registry of births at 11 academic tertiary care centers nationwide. They focused on 4,274 infants who were born during 3 epochs – 2000-2003, 2004-2007, and 2008-2011 – and were evaluated for motor function, sensory impairment, and cognitive delay at a corrected age of 18-22 months.
The percentage of infants who survived without neurodevelopmental impairment increased over time, from 16% during the first epoch to 20% during the third epoch. However, the percentage who survived with neurodevelopmental impairment also increased, from 15% during the first epoch to 16% during the third epoch (New Engl. J. Med. 2017 Feb 16. doi: 10.1056/NEJMoa1605566).
The rates of active treatment of these periviable infants didn’t change significantly over time. Overall, 22% of infants born at 22 weeks, 71% of those born at 23 weeks, and 95% of those born at 24 weeks received active treatment at birth. Therefore, the overall decrease in mortality and the 4% improvement in neurodevelopmental outcomes wasn’t attributable to greater use of active treatment for periviable infants over time, said Dr. Younge and her associates.
Despite these small but significant improvements in outcomes, “the incidence of death, neurodevelopmental impairment, and other adverse outcomes remains high in this population,” they noted.
This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, the National Center for Research Resources, and the National Center for Advancing Translational Sciences for the Neonatal Research Network’s Generic Database and Follow-up Studies. Dr. Younge reported having no relevant financial disclosures; two of her associates reported ties to Pediatrix Medical Group and rEVO Biologics.
The study by Younge et al. was limited in that it only included infants born in 11 academic tertiary care medical centers.
This study population represents only 4%-5% of periviable infants born in the United States, so the findings are not generalizable.
Prakesh S. Shah, MD, is in the department of pediatrics and the Institute of Health Policy, Management, and Evaluation at Mount Sinai Hospital, Toronto, and the University of Toronto. He reported having no relevant financial disclosures. Dr. Shah made these remarks in an editorial accompanying Dr. Younge’s report (N Engl J Med. 2017 Feb 16. doi: 10.1056/NEJMe1616539).
The study by Younge et al. was limited in that it only included infants born in 11 academic tertiary care medical centers.
This study population represents only 4%-5% of periviable infants born in the United States, so the findings are not generalizable.
Prakesh S. Shah, MD, is in the department of pediatrics and the Institute of Health Policy, Management, and Evaluation at Mount Sinai Hospital, Toronto, and the University of Toronto. He reported having no relevant financial disclosures. Dr. Shah made these remarks in an editorial accompanying Dr. Younge’s report (N Engl J Med. 2017 Feb 16. doi: 10.1056/NEJMe1616539).
The study by Younge et al. was limited in that it only included infants born in 11 academic tertiary care medical centers.
This study population represents only 4%-5% of periviable infants born in the United States, so the findings are not generalizable.
Prakesh S. Shah, MD, is in the department of pediatrics and the Institute of Health Policy, Management, and Evaluation at Mount Sinai Hospital, Toronto, and the University of Toronto. He reported having no relevant financial disclosures. Dr. Shah made these remarks in an editorial accompanying Dr. Younge’s report (N Engl J Med. 2017 Feb 16. doi: 10.1056/NEJMe1616539).
Among periviable infants born at 11 tertiary care centers in 2000 through 2011, the rate of survival without neurodevelopmental impairment increased a small but significant 4%, according to a report published online Feb. 16 in the New England Journal of Medicine.
The rate of survival with neurodevelopmental impairment also increased, although to a lesser extent (1%).
“These findings are important for guiding counseling and decision making with respect to periviable birth. Prognosis continues to be guarded; in the most recent epoch [time period in our study], mortality was 64%, and 43% of surviving infants had neurodevelopmental impairment,” they noted.
The investigators defined such impairment as moderate or severe cerebral palsy, Gross Motor Function Classification System level of at least 2 on a scale of 1-5, profound hearing loss requiring amplification in both ears, profound visual impairment in both eyes, or cognitive impairment such as a Mental Developmental Index score of less than 70 or a Cognitive Composite score of less than 85.
To examine time trends in the outcomes of periviable infants, Dr. Younge of Duke University, Durham, N.C., and her associates analyzed data from the network’s registry of births at 11 academic tertiary care centers nationwide. They focused on 4,274 infants who were born during 3 epochs – 2000-2003, 2004-2007, and 2008-2011 – and were evaluated for motor function, sensory impairment, and cognitive delay at a corrected age of 18-22 months.
The percentage of infants who survived without neurodevelopmental impairment increased over time, from 16% during the first epoch to 20% during the third epoch. However, the percentage who survived with neurodevelopmental impairment also increased, from 15% during the first epoch to 16% during the third epoch (New Engl. J. Med. 2017 Feb 16. doi: 10.1056/NEJMoa1605566).
The rates of active treatment of these periviable infants didn’t change significantly over time. Overall, 22% of infants born at 22 weeks, 71% of those born at 23 weeks, and 95% of those born at 24 weeks received active treatment at birth. Therefore, the overall decrease in mortality and the 4% improvement in neurodevelopmental outcomes wasn’t attributable to greater use of active treatment for periviable infants over time, said Dr. Younge and her associates.
Despite these small but significant improvements in outcomes, “the incidence of death, neurodevelopmental impairment, and other adverse outcomes remains high in this population,” they noted.
This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, the National Center for Research Resources, and the National Center for Advancing Translational Sciences for the Neonatal Research Network’s Generic Database and Follow-up Studies. Dr. Younge reported having no relevant financial disclosures; two of her associates reported ties to Pediatrix Medical Group and rEVO Biologics.
Among periviable infants born at 11 tertiary care centers in 2000 through 2011, the rate of survival without neurodevelopmental impairment increased a small but significant 4%, according to a report published online Feb. 16 in the New England Journal of Medicine.
The rate of survival with neurodevelopmental impairment also increased, although to a lesser extent (1%).
“These findings are important for guiding counseling and decision making with respect to periviable birth. Prognosis continues to be guarded; in the most recent epoch [time period in our study], mortality was 64%, and 43% of surviving infants had neurodevelopmental impairment,” they noted.
The investigators defined such impairment as moderate or severe cerebral palsy, Gross Motor Function Classification System level of at least 2 on a scale of 1-5, profound hearing loss requiring amplification in both ears, profound visual impairment in both eyes, or cognitive impairment such as a Mental Developmental Index score of less than 70 or a Cognitive Composite score of less than 85.
To examine time trends in the outcomes of periviable infants, Dr. Younge of Duke University, Durham, N.C., and her associates analyzed data from the network’s registry of births at 11 academic tertiary care centers nationwide. They focused on 4,274 infants who were born during 3 epochs – 2000-2003, 2004-2007, and 2008-2011 – and were evaluated for motor function, sensory impairment, and cognitive delay at a corrected age of 18-22 months.
The percentage of infants who survived without neurodevelopmental impairment increased over time, from 16% during the first epoch to 20% during the third epoch. However, the percentage who survived with neurodevelopmental impairment also increased, from 15% during the first epoch to 16% during the third epoch (New Engl. J. Med. 2017 Feb 16. doi: 10.1056/NEJMoa1605566).
The rates of active treatment of these periviable infants didn’t change significantly over time. Overall, 22% of infants born at 22 weeks, 71% of those born at 23 weeks, and 95% of those born at 24 weeks received active treatment at birth. Therefore, the overall decrease in mortality and the 4% improvement in neurodevelopmental outcomes wasn’t attributable to greater use of active treatment for periviable infants over time, said Dr. Younge and her associates.
Despite these small but significant improvements in outcomes, “the incidence of death, neurodevelopmental impairment, and other adverse outcomes remains high in this population,” they noted.
This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, the National Center for Research Resources, and the National Center for Advancing Translational Sciences for the Neonatal Research Network’s Generic Database and Follow-up Studies. Dr. Younge reported having no relevant financial disclosures; two of her associates reported ties to Pediatrix Medical Group and rEVO Biologics.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: The percentage of infants who survived without neurodevelopmental impairment increased over time, from 16% to 20%, as did the percentage who survived with neurodevelopmental impairment, from 15% to 16%.
Data source: A cohort study involving 4,274 infants in an NIH registry born at 22-24 weeks’ gestation and evaluated for neurodevelopmental impairment at a corrected age of 18-22 months.
Disclosures: This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, the National Center for Research Resources, and the National Center for Advancing Translational Sciences for the Neonatal Research Network’s Generic Database and Follow-up Studies. Dr. Younge reported having no relevant financial disclosures; two of her associates reported ties to Pediatrix Medical Group and rEVO Biologics.
Toddlers’ neurodevelopmental deficits linked with maternal diabetes
LAS VEGAS – Children born to obese women with insulin resistance during pregnancy showed significantly impaired neurodevelopment at 2 years of age, compared with children born to obese mothers without insulin resistance in a prospective observational study with 75 pregnant women.
The neurodevelopmental deficits were specific for the domains of motor function and attention, and the deficits correlated with several markers of abnormal glucose and fat metabolism in the insulin-resistant women, Alison G. Cahill, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“The differences in neurodevelopment appear to not be global but instead specifically affect domains of motor development and attention,” said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis. “These findings are consistent with results from animal studies that suggest certain brain regions are more sensitive than others to metabolic abnormalities” while in utero.
“These are among the first data in humans to characterize the impact of metabolic abnormalities on brain development,” she added.
Dr. Cahill said that results from the lean mothers uniformly matched those from the obese mothers without insulin resistance, and so for brevity she only reported results from the obese control group.
Average gestational age at birth was 37 weeks in the insulin-resistant mothers and 38.7 weeks among the obese mothers without insulin resistance, a significant difference. Birth weight averaged 3,617 g in the mothers with insulin resistance and 3,373 g in the mothers without insulin resistance, a difference that was not statistically significant.
Dr. Cahill and her associates assessed the 2-year-olds with a battery of behavioral and functional assessments. They measured motor function, cognition, and language with the Bayley Scales of Infant and Toddler Development, prespecified as the study’s primary endpoint. They also applied the Modified Checklist for Autism in Toddlers (M-CHAT), as well as the Infant-Toddler Social and Emotional Assessment (ITSEA) to assess competence, externalizing, internalizing, and dysregulation.
The results of these analyses showed statistically significant deficits for the motor composite score on the Bayley assessment and for the competence component of the ITSEA assessment, Dr. Cahill reported. The average composite Bayley motor score was 88 in children from mothers with insulin resistance and 98 in the control children, a statistically significant difference.
Further analyses showed that the motor deficit was primarily in fine motor function, and that motor scores were depressed throughout the entire cohort of children born to mothers with insulin resistance.
Depressed competence scores on the ITSEA assessment reflect attention abnormalities, she explained.
A final analysis examined the correlation between the motor deficits identified and various metabolic tests of fat, glucose, and protein metabolism run on the enrolled mothers during the last weeks of gestation. This showed significant links between depressed motor development and maternal lipolytic rate, plasma free fatty acids, and hepatic glucose output.
This finding “suggests an association between abnormal lipid and glucose metabolism in mothers and aspects of neurodevelopment” in their children, Dr. Cahill said.
Dr. Cahill had no disclosures.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Children born to obese women with insulin resistance during pregnancy showed significantly impaired neurodevelopment at 2 years of age, compared with children born to obese mothers without insulin resistance in a prospective observational study with 75 pregnant women.
The neurodevelopmental deficits were specific for the domains of motor function and attention, and the deficits correlated with several markers of abnormal glucose and fat metabolism in the insulin-resistant women, Alison G. Cahill, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“The differences in neurodevelopment appear to not be global but instead specifically affect domains of motor development and attention,” said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis. “These findings are consistent with results from animal studies that suggest certain brain regions are more sensitive than others to metabolic abnormalities” while in utero.
“These are among the first data in humans to characterize the impact of metabolic abnormalities on brain development,” she added.
Dr. Cahill said that results from the lean mothers uniformly matched those from the obese mothers without insulin resistance, and so for brevity she only reported results from the obese control group.
Average gestational age at birth was 37 weeks in the insulin-resistant mothers and 38.7 weeks among the obese mothers without insulin resistance, a significant difference. Birth weight averaged 3,617 g in the mothers with insulin resistance and 3,373 g in the mothers without insulin resistance, a difference that was not statistically significant.
Dr. Cahill and her associates assessed the 2-year-olds with a battery of behavioral and functional assessments. They measured motor function, cognition, and language with the Bayley Scales of Infant and Toddler Development, prespecified as the study’s primary endpoint. They also applied the Modified Checklist for Autism in Toddlers (M-CHAT), as well as the Infant-Toddler Social and Emotional Assessment (ITSEA) to assess competence, externalizing, internalizing, and dysregulation.
The results of these analyses showed statistically significant deficits for the motor composite score on the Bayley assessment and for the competence component of the ITSEA assessment, Dr. Cahill reported. The average composite Bayley motor score was 88 in children from mothers with insulin resistance and 98 in the control children, a statistically significant difference.
Further analyses showed that the motor deficit was primarily in fine motor function, and that motor scores were depressed throughout the entire cohort of children born to mothers with insulin resistance.
Depressed competence scores on the ITSEA assessment reflect attention abnormalities, she explained.
A final analysis examined the correlation between the motor deficits identified and various metabolic tests of fat, glucose, and protein metabolism run on the enrolled mothers during the last weeks of gestation. This showed significant links between depressed motor development and maternal lipolytic rate, plasma free fatty acids, and hepatic glucose output.
This finding “suggests an association between abnormal lipid and glucose metabolism in mothers and aspects of neurodevelopment” in their children, Dr. Cahill said.
Dr. Cahill had no disclosures.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Children born to obese women with insulin resistance during pregnancy showed significantly impaired neurodevelopment at 2 years of age, compared with children born to obese mothers without insulin resistance in a prospective observational study with 75 pregnant women.
The neurodevelopmental deficits were specific for the domains of motor function and attention, and the deficits correlated with several markers of abnormal glucose and fat metabolism in the insulin-resistant women, Alison G. Cahill, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
“The differences in neurodevelopment appear to not be global but instead specifically affect domains of motor development and attention,” said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis. “These findings are consistent with results from animal studies that suggest certain brain regions are more sensitive than others to metabolic abnormalities” while in utero.
“These are among the first data in humans to characterize the impact of metabolic abnormalities on brain development,” she added.
Dr. Cahill said that results from the lean mothers uniformly matched those from the obese mothers without insulin resistance, and so for brevity she only reported results from the obese control group.
Average gestational age at birth was 37 weeks in the insulin-resistant mothers and 38.7 weeks among the obese mothers without insulin resistance, a significant difference. Birth weight averaged 3,617 g in the mothers with insulin resistance and 3,373 g in the mothers without insulin resistance, a difference that was not statistically significant.
Dr. Cahill and her associates assessed the 2-year-olds with a battery of behavioral and functional assessments. They measured motor function, cognition, and language with the Bayley Scales of Infant and Toddler Development, prespecified as the study’s primary endpoint. They also applied the Modified Checklist for Autism in Toddlers (M-CHAT), as well as the Infant-Toddler Social and Emotional Assessment (ITSEA) to assess competence, externalizing, internalizing, and dysregulation.
The results of these analyses showed statistically significant deficits for the motor composite score on the Bayley assessment and for the competence component of the ITSEA assessment, Dr. Cahill reported. The average composite Bayley motor score was 88 in children from mothers with insulin resistance and 98 in the control children, a statistically significant difference.
Further analyses showed that the motor deficit was primarily in fine motor function, and that motor scores were depressed throughout the entire cohort of children born to mothers with insulin resistance.
Depressed competence scores on the ITSEA assessment reflect attention abnormalities, she explained.
A final analysis examined the correlation between the motor deficits identified and various metabolic tests of fat, glucose, and protein metabolism run on the enrolled mothers during the last weeks of gestation. This showed significant links between depressed motor development and maternal lipolytic rate, plasma free fatty acids, and hepatic glucose output.
This finding “suggests an association between abnormal lipid and glucose metabolism in mothers and aspects of neurodevelopment” in their children, Dr. Cahill said.
Dr. Cahill had no disclosures.
[email protected] On Twitter @mitchelzoler
Key clinical point:
Major finding: The Bayley motor scale score averaged 88 in children from insulin-resistant mothers and 98 when no insulin resistance existed.
Data source: Prospective, single-center observational study with 75 pregnant women.
Disclosures: Dr. Cahill had no disclosures.
Capping gestational weight gain didn’t deliver better pregnancy outcomes
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
Key clinical point:
Major finding: Behavioral interventions linked with average reductions in gestational weight gain of 4.6 pounds in MOMFIT and 3.5 pounds in LIFE-Moms.
Data source: MOMFIT and LIFE-Moms, two single-center randomized trials with 263 and 267 mothers, respectively.
Disclosures: Neither trial had commercial support. Dr. Peaceman and Dr. Cahill had no relevant disclosures.
Don’t delay pneumococcal conjugate vaccine for preterm infants
There should be no hesitation in administering the routine vaccination schedule for 13-valent pneumococcal conjugate vaccine (PCV13) on account of gestational age or birth weight in preterm infants, researchers concluded.
In a phase IV study, researchers compared 100 term with 100 preterm infants; both groups were vaccinated on the routine schedule at ages 2, 3, 4, and 12 months. After the 12-month (toddler) dose of the PCV13, the infants were evaluated for serum antibody persistence at 12 and 24 months. “To date, no studies have examined the long-term persistence of immune responses to PCV13 in formerly preterm infants,” noted Federico Martinón-Torres, MD, PhD, of Hospital Clínico Universitario de Santiago de Compostela, Spain, and his coauthors. 
In the study, at six sites in Spain and five sites in Poland between October 2010 and January 2014, both groups were checked for geometric mean concentrations of serotype-specific anticapsular immunoglobulin G binding antibodies and for opsonophagocytic activity. All 200 subjects were white and were generally healthy; the preterm infants were grouped by gestational age at birth of less than 29 weeks (n = 25), 29 weeks to less than 32 weeks (n = 50), or 32 weeks to less than 37 weeks (n = 25). Twelve subjects dropped out of the study by the first year’s evaluation, and another eight of the term subjects and seven of preterm subjects dropped out by the second year’s evaluation (Ped Infect Dis J. 2017. doi: 10.1097/INF.0000000000001428).
At both follow-up time points, no discernible patterns were observed in IgG GMCs for any serotype or in opsonophagocytic activity geometric mean titers across preterm subgroups based on gestational age.
“The vaccination phase of the study demonstrated that preterm infants are able to generate an immune response to PCV13 that is likely to protect against invasive pneumococcal disease. However, IgG GMCs were lower in preterm than term infants for nearly half of the serotypes at all time points. Antipneumococcal IgG levels in preterm infants were generally lower than in term infants, but fewer differences in opsonophagocytic activity were seen between the groups,” Dr. Martinón-Torres and his associates reported.
Pfizer funded the study. Dr. Martinón-Torres reported receiving research grants and/or honoraria as a consultant/adviser and/or speaker and for conducting vaccine trials for GlaxoSmithKline, MedImmune, Merck, Novartis, Pfizer/Wyeth, Sanofi Pasteur, and the Carlos III Health Institute. Several coauthors disclosed ties with pharmaceutical companies; four are stock-holding employees of Pfizer and another is an employee of a company contracted by Pfizer.
There should be no hesitation in administering the routine vaccination schedule for 13-valent pneumococcal conjugate vaccine (PCV13) on account of gestational age or birth weight in preterm infants, researchers concluded.
In a phase IV study, researchers compared 100 term with 100 preterm infants; both groups were vaccinated on the routine schedule at ages 2, 3, 4, and 12 months. After the 12-month (toddler) dose of the PCV13, the infants were evaluated for serum antibody persistence at 12 and 24 months. “To date, no studies have examined the long-term persistence of immune responses to PCV13 in formerly preterm infants,” noted Federico Martinón-Torres, MD, PhD, of Hospital Clínico Universitario de Santiago de Compostela, Spain, and his coauthors.
In the study, at six sites in Spain and five sites in Poland between October 2010 and January 2014, both groups were checked for geometric mean concentrations of serotype-specific anticapsular immunoglobulin G binding antibodies and for opsonophagocytic activity. All 200 subjects were white and were generally healthy; the preterm infants were grouped by gestational age at birth of less than 29 weeks (n = 25), 29 weeks to less than 32 weeks (n = 50), or 32 weeks to less than 37 weeks (n = 25). Twelve subjects dropped out of the study by the first year’s evaluation, and another eight of the term subjects and seven of preterm subjects dropped out by the second year’s evaluation (Ped Infect Dis J. 2017. doi: 10.1097/INF.0000000000001428).
At both follow-up time points, no discernible patterns were observed in IgG GMCs for any serotype or in opsonophagocytic activity geometric mean titers across preterm subgroups based on gestational age.
“The vaccination phase of the study demonstrated that preterm infants are able to generate an immune response to PCV13 that is likely to protect against invasive pneumococcal disease. However, IgG GMCs were lower in preterm than term infants for nearly half of the serotypes at all time points. Antipneumococcal IgG levels in preterm infants were generally lower than in term infants, but fewer differences in opsonophagocytic activity were seen between the groups,” Dr. Martinón-Torres and his associates reported.
Pfizer funded the study. Dr. Martinón-Torres reported receiving research grants and/or honoraria as a consultant/adviser and/or speaker and for conducting vaccine trials for GlaxoSmithKline, MedImmune, Merck, Novartis, Pfizer/Wyeth, Sanofi Pasteur, and the Carlos III Health Institute. Several coauthors disclosed ties with pharmaceutical companies; four are stock-holding employees of Pfizer and another is an employee of a company contracted by Pfizer.
There should be no hesitation in administering the routine vaccination schedule for 13-valent pneumococcal conjugate vaccine (PCV13) on account of gestational age or birth weight in preterm infants, researchers concluded.
In a phase IV study, researchers compared 100 term with 100 preterm infants; both groups were vaccinated on the routine schedule at ages 2, 3, 4, and 12 months. After the 12-month (toddler) dose of the PCV13, the infants were evaluated for serum antibody persistence at 12 and 24 months. “To date, no studies have examined the long-term persistence of immune responses to PCV13 in formerly preterm infants,” noted Federico Martinón-Torres, MD, PhD, of Hospital Clínico Universitario de Santiago de Compostela, Spain, and his coauthors.
In the study, at six sites in Spain and five sites in Poland between October 2010 and January 2014, both groups were checked for geometric mean concentrations of serotype-specific anticapsular immunoglobulin G binding antibodies and for opsonophagocytic activity. All 200 subjects were white and were generally healthy; the preterm infants were grouped by gestational age at birth of less than 29 weeks (n = 25), 29 weeks to less than 32 weeks (n = 50), or 32 weeks to less than 37 weeks (n = 25). Twelve subjects dropped out of the study by the first year’s evaluation, and another eight of the term subjects and seven of preterm subjects dropped out by the second year’s evaluation (Ped Infect Dis J. 2017. doi: 10.1097/INF.0000000000001428).
At both follow-up time points, no discernible patterns were observed in IgG GMCs for any serotype or in opsonophagocytic activity geometric mean titers across preterm subgroups based on gestational age.
“The vaccination phase of the study demonstrated that preterm infants are able to generate an immune response to PCV13 that is likely to protect against invasive pneumococcal disease. However, IgG GMCs were lower in preterm than term infants for nearly half of the serotypes at all time points. Antipneumococcal IgG levels in preterm infants were generally lower than in term infants, but fewer differences in opsonophagocytic activity were seen between the groups,” Dr. Martinón-Torres and his associates reported.
Pfizer funded the study. Dr. Martinón-Torres reported receiving research grants and/or honoraria as a consultant/adviser and/or speaker and for conducting vaccine trials for GlaxoSmithKline, MedImmune, Merck, Novartis, Pfizer/Wyeth, Sanofi Pasteur, and the Carlos III Health Institute. Several coauthors disclosed ties with pharmaceutical companies; four are stock-holding employees of Pfizer and another is an employee of a company contracted by Pfizer.
Key clinical point:
Major finding: IgG GMCs were lower in preterm than term infants for nearly half of the serotypes at all time points. Antipneumococcal IgG levels in preterm infants were generally lower than in term infants, but fewer differences in opsonophagocytic activity were seen between the groups.
Data source: In a phase IV study, 100 term and 100 preterm infants were evaluated for serum antibody persistence at 12 and 24 months.
Disclosures: Pfizer funded the study. Dr. Martinón-Torres reported receiving research grants and/or honoraria as a consultant/adviser and/or speaker and for conducting vaccine trials for GlaxoSmithKline, MedImmune, Merck, Novartis, Pfizer/Wyeth, Sanofi Pasteur, and the Carlos III Health Institute. Several coauthors disclosed ties with pharmaceutical companies; four are stock-holding employees of Pfizer and another is an employee of a company contracted by Pfizer.