TY - JOUR
T1 - Neonatal Outcomes in the MONEAD Study of Pregnant Women with Epilepsy
AU - MONEAD Investigator Group
AU - Van Marter, Linda J.
AU - Pennell, Page B.
AU - Brown, Carrie
AU - Hartman, Adam L.
AU - May, Ryan C.
AU - McElrath, Thomas
AU - Ippolito, Dominic
AU - Meador, Kimford J.
AU - Bagic, Anto
AU - Barkley, Gregory
AU - Cavitt, Jennifer
AU - DeWolfe, Jennifer
AU - French, Jacqueline
AU - Gedzelman, Evan
AU - Gerard, Elizabeth
AU - Hwang, Sean
AU - Kalayjian, Laura
AU - Krauss, Gregory
AU - Labiner, David
AU - McCabe, Paul
AU - Miller, John
AU - Pack, Alison
AU - Penovich, Patricia
AU - Sam, Maria
AU - Serrano, Enrique
AU - Strickland, Suzanne
N1 - Funding Information:
Supported by National Institutes of Health (NIH) National Institute of Neurological Disorders & Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (#U01-NS038455 [to K.M. and P.P.], U01-NS050659 [to R.M.], and 2U01-NS038455 [to K.M., P.P., and R.M]). The NIH had a role in the analyses and writing of the manuscript but had no role in the design, conduct of the study, or decision to submit for publication. K.M. has received research support from the NIH and Sunovion Pharmaceuticals; has received travel support from UCB Pharma; and the Epilepsy Study Consortium pays Stanford University for his research consultant time related to Eisai, GW Pharmaceuticals, NeuroPace, Novartis, Supernus, Upsher-Smith Laboratories, UCB Pharma, and Vivus Pharmaceuticals. P.P. has received research support from the NIH and the Epilepsy Foundation; and has received honoraria and travel support from American Epilepsy Society, American Academy of Neurology, Epilepsy Foundation, NIH, and academic institutions for CME lectures. L.V.M. has received support from Shire Pharmaceuticals (now Takeda) for travel to several investigator meetings. T.M. has received research support from the NIH and NxPrenatal; and serves on advisory boards for Hoffman La Roche and Mirvie. A.H. is employed by the NINDS. R.M. declares no conflicts of interest.
Publisher Copyright:
© 2021
PY - 2021/6/1
Y1 - 2021/6/1
N2 - Objective: To determine whether growth measures at birth differ between offspring of pregnant women with epilepsy and healthy pregnant women. Study design: The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is a National Institutes of Health–funded, prospective, observational, multicenter investigation of pregnancy outcomes for mothers and their infants. Between 2012 and 2016, pregnant women with epilepsy and healthy pregnant women were enrolled at 20 US epilepsy centers. Pregnant women with epilepsy were exposed to various antiepileptic drugs. The main outcome measure was small for gestational age at birth. Principal univariate and multivariate analyses compared outcomes between pregnant women with epilepsy and healthy pregnant women. Secondary analyses focused on outcomes among mothers receiving different antiepileptic drug therapies. Results: In total, 345 infants were born to 331 pregnant women with epilepsy and 106 infants were born to 102 healthy pregnant women. No differences were seen between infants born to pregnant women with epilepsy vs healthy pregnant women in preterm births, major congenital malformations, 5-minute Apgar <6, special care nursery or neonatal intensive care unit admission, gestational age, or any growth measure. There was no difference in the rates of small for gestational age status among infants born to pregnant women with epilepsy vs healthy pregnant women; however, infants born to mothers receiving topiramate had lower birth weight z scores and lamotrigine higher birth weight z scores compared with other monotherapies. The greatest rate of special care nursery or neonatal intensive care unit admission was observed among those on oxcarbazepine monotherapy. Conclusions: Maternal treatment with antiepileptic drugs, overall, appears unassociated with adverse early neonatal outcomes. However, specific monotherapies appear to affect fetal growth with, on average, the greatest reduction in birth weight z score observed among infants born to pregnant women with epilepsy exposed to topiramate monotherapy. Trial registration: ClinicalTrials.govNCT01730170
AB - Objective: To determine whether growth measures at birth differ between offspring of pregnant women with epilepsy and healthy pregnant women. Study design: The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is a National Institutes of Health–funded, prospective, observational, multicenter investigation of pregnancy outcomes for mothers and their infants. Between 2012 and 2016, pregnant women with epilepsy and healthy pregnant women were enrolled at 20 US epilepsy centers. Pregnant women with epilepsy were exposed to various antiepileptic drugs. The main outcome measure was small for gestational age at birth. Principal univariate and multivariate analyses compared outcomes between pregnant women with epilepsy and healthy pregnant women. Secondary analyses focused on outcomes among mothers receiving different antiepileptic drug therapies. Results: In total, 345 infants were born to 331 pregnant women with epilepsy and 106 infants were born to 102 healthy pregnant women. No differences were seen between infants born to pregnant women with epilepsy vs healthy pregnant women in preterm births, major congenital malformations, 5-minute Apgar <6, special care nursery or neonatal intensive care unit admission, gestational age, or any growth measure. There was no difference in the rates of small for gestational age status among infants born to pregnant women with epilepsy vs healthy pregnant women; however, infants born to mothers receiving topiramate had lower birth weight z scores and lamotrigine higher birth weight z scores compared with other monotherapies. The greatest rate of special care nursery or neonatal intensive care unit admission was observed among those on oxcarbazepine monotherapy. Conclusions: Maternal treatment with antiepileptic drugs, overall, appears unassociated with adverse early neonatal outcomes. However, specific monotherapies appear to affect fetal growth with, on average, the greatest reduction in birth weight z score observed among infants born to pregnant women with epilepsy exposed to topiramate monotherapy. Trial registration: ClinicalTrials.govNCT01730170
KW - anticonvulsants
KW - epilepsy
KW - neonate
KW - newborn
KW - outcomes
KW - pregnancy
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U2 - 10.1016/j.ympdx.2021.100073
DO - 10.1016/j.ympdx.2021.100073
M3 - Article
AN - SCOPUS:85110196002
SN - 2590-0420
VL - 7
JO - Journal of Pediatrics: X
JF - Journal of Pediatrics: X
M1 - 100073
ER -