Fetal loss and malformations in the MONEAD study of pregnant women with epilepsy.
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%) (
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 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.
Meador KJ, Pennell PB, May RC, Van Marter L, McElrath TF, Brown C, Gerard E, Kalayjian L, Gedzelman E, Penovich P, Cavitt J, French J, Hwang S, Pack AM, Sam M, Birnbaum AK, Finnell R; MONEAD Investigator Group. Fetal loss and malformations in the MONEAD study of pregnant women with epilepsy. Neurology. 2020 Apr 7;94(14):e1502-e1511. doi: 10.1212/WNL.0000000000008687. Epub 2019 Dec 5. PMID: 31806691; PMCID: PMC7251524.