TY - JOUR
T1 - Fetal loss and malformations in the MONEAD study of pregnant women with epilepsy
AU - Meador, Kimford J.
AU - Pennell, Page B.
AU - May, Ryan C.
AU - Van Marter, Linda
AU - McElrath, Thomas F.
AU - Brown, Carrie
AU - Gerard, Elizabeth
AU - Kalayjian, Laura
AU - Gedzelman, Evan
AU - Penovich, Patricia
AU - Cavitt, Jennifer
AU - French, Jacqueline
AU - Hwang, Sean
AU - Pack, Alison M.
AU - Sam, Maria
AU - Birnbaum, Angela K.
AU - Finnell, Richard
N1 - Funding Information:
This work was supported by NIH NINDS, NICHD U01-NS038455 (K.J.M., P.B.P.), U01-NS050659 (R.C.M.), and 2U01-NS038455 (K.J.M., P.B.P., R.C.M.). The funding source had no role in the analyses, writing the manuscript, or the decision to submit for publication.
Funding Information:
K. Meador has received research support from the NIH and Sunovion Pharmaceuticals and travel support from UCB Pharma. The Epilepsy Study Consortium pays Dr. Meador’s university for his research consultant time related to Eisai, GW Pharmaceuticals, NeuroPace, Novartis, Supernus, Upsher-Smith Laboratories, UCB Pharma, and Vivus Pharmaceuticals. In addition, Dr. Meador is Coinvestigator and Director of Cognitive Core of the Human Epilepsy Project for the Epilepsy Study Consortium. P. Pennell has received research support from the NIH and the Epilepsy Foundation
Publisher Copyright:
© American Academy of Neurology.
PY - 2020/4/7
Y1 - 2020/4/7
N2 - 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.
AB - 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.
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U2 - 10.1212/WNL.0000000000008687
DO - 10.1212/WNL.0000000000008687
M3 - Article
C2 - 31806691
AN - SCOPUS:85085027593
SN - 0028-3878
VL - 94
SP - E1502-E1511
JO - Neurology
JF - Neurology
IS - 14
ER -