Fetal loss and malformations in the MONEAD study of pregnant women with epilepsy

作者：Kimford J. Meador, Page B. Pennell, Ryan May, Linda Van Marter, Thomas F. McElrath, Carrie Brown, Elizabeth E. Gerard, Laura A. Kalayjian, Evan Gedzelman, Patricia Penovich, Jennifer Cavitt, Jacqueline A. French, Sean Hwang, Alison Pack, Maria Sam, Angela K. Birnbaum, Richard H. Finnell, for the MONEAD Investigator Group · 发表于：Neurology · 年份：2019 · DOI：10.1212/wnl.0000000000008687 · 被引用次数：53 · 研究领域：Pharmacological Effects and Toxicity Studies、Epilepsy research and treatment、Pregnancy and Medication Impact

Objective To examine occurrence of severe adverse fetal outcomes (SAO), including fetal loss and major congenital malformations (MCMs), in pregnant women with epilepsy (PWWE) vs healthy pregnant women (HPW). Methods The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is an NIH-funded, prospective, observational, multicenter investigation of pregnancy outcomes for both mother and child, which enrolled women December 2012 through January 2016. Results The 351 PWWE had 365 conceptions, and 105 HPW had 109 conceptions. SAOs occurred more often in PWWE (7.9%) vs HPW (1.9%) (p = 0.025) with odds ratio (OR) 4.45 (95% confidence intervals [CI] 1.04–19.01). There were no significant differences for fetal loss (2.8% vs 0%, p = 0.126) or MCMs (5.2% vs 1.9%, p = 0.185; OR 2.86, 95% CI 0.65–12.53) individually. No fetal losses in PWWE appeared to be related to acute seizures. Outcomes were not affected by periconceptional folate, unplanned/unwanted pregnancies, prior maternal pregnancy history, or antiepileptic drug (AED) blood levels, except for an AED level effect for fetal loss that appeared to be due to polytherapy. Combined maternal or paternal family history of MCM was marginally associated with increased SAOs (p = 0.046). Conclusions The findings provide additional information on risks of SAOs in PWWE, assessing effects of both AED levels and periconceptional folate. Group differences in average enrollment gestational age could have affected f...