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Neonatal Outcomes in the MONEAD Study of Pregnant Women with Epilepsy


Conference Paper

Van Marter, L.J.; Pennell, P.; Brown, C.; May, R.; McElrath, T.; Ippolito, D.; Meador, K.J.

Pediatric Academic Socities (PAS)


Background: Improvements in obstetrical care have led to successful childbearing among a greater number of women who have chronic illnesses, including epilspsy. Effects of antiepileptic drugs (AEDs) on the fetus and newborn are important in determining short and long-term health effects. Objective: This analysis focused on birth weight (BW) and other neonatal outcomes of infants born to mothers enrolled in this study of pregnant women with epilepsy (PWWE) vs. healthy pregnant women (HPW). MONEAD rates of fetal loss and congenital anomalies, have been previously reported. Design/Methods: The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is a NIH-funded, prospective, observational, multi-center investigation of pregnancy outcomes that enrolled women December 2012 - January 2016 at 20 clinical sites and compared PWWE and HPW. PWWE and HPW who gave birth while enrolled in the study and their newborns were included in the analysis population. Statistical methods employed included: Pearson's chi-squared test, Fisher's exact test, Student's t-tests and Wilcoxon rank-sum tests. Results: 345 infants were born to the 331 PWWE and 106 infants were born to the 102 HPW. Infants born to PWWE were not at increased risk of preterm birth, having major malformation, scoring < 6 on 5" Apgar, or requiring NICU admission. Overall, no difference was seen between infants born to PWWE vs. HPW in gestational age (GA) or any growth parameter, including BW, head circumference, and their respective z-scores, although there was an overall trend for infants born to PWWE to be of average BW for GA compared with large or small for GA infants more likely to be born to HPW. Infants born to mothers receiving topiramate had lower (mean±SD: -1.23 ± 0.32 ) and lamotrigine higher (mean±SD: 0.15 ± 0.77) BW z-scores compared with mothers receiving other monotherapies. Among infants whose mothers were receiving monotherapy at study enrollment, the highest likelihood of NICU admission was seen among those treated with oxcarbazepine (7 of 15; 46.7%). Conclusion(s): Maternal treatment with AEDs overall appears unassociated with adverse early neonatal outcomes. However, specific AEDs vary in their association with birth weight, lamotrigine exposure being associated with the greatest reduction. The elevated rate of NICU admission among infants born to pregnant women receiving oxcarbazepine warrants further investigation.

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