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

Kimford J. Meador, Page B. Pennell, Ryan C. May, Linda Van Marter, Thomas F. McElrath, Carrie Brown, Elizabeth Gerard, Laura Kalayjian, Evan Gedzelman, Patricia Penovich, Jennifer Cavitt, Jacqueline French, Sean Hwang, Alison M. Pack, Maria Sam, Angela K. Birnbaum, Richard Finnell

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Abstract

ObjectiveTo 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).MethodsThe 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.ResultsThe 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).ConclusionsThe 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 fetal loss results. Analyses are limited by small sample sizes as the MONEAD study was not powered for these secondary outcomes. The large majority of pregnancies in women with epilepsy do not have SOAs.

Original languageEnglish (US)
Pages (from-to)E1502-E1511
JournalNeurology
Volume94
Issue number14
DOIs
StatePublished - Apr 7 2020

PubMed: MeSH publication types

  • Journal Article
  • Multicenter Study
  • Observational Study
  • Research Support, N.I.H., Extramural

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    Meador, K. J., Pennell, P. B., May, R. C., Van Marter, L., McElrath, T. F., Brown, C., Gerard, E., Kalayjian, L., Gedzelman, E., Penovich, P., Cavitt, J., French, J., Hwang, S., Pack, A. M., Sam, M., Birnbaum, A. K., & Finnell, R. (2020). Fetal loss and malformations in the MONEAD study of pregnant women with epilepsy. Neurology, 94(14), E1502-E1511. https://doi.org/10.1212/WNL.0000000000008687