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(Abst. 1.217), 2017

Obstetric and Neonatal Outcomes in the MONEAD Study
Authors: Page B. Pennell, Harvard Medical School, Brigham and Women's Hospital; Kimford J. Meador, Stanford University; Ryan May, Emmes Corporation; Thomas McElrath, Harvard Medical School, Brigham and Women's Hospital; Linda VanMarter, Harvard Medical School, Brigham and Women's Hospital; Dominic Ippolito, Emmes Corporation; Taylor Weilnau, Brigham and Women's Hospital; Yvonne Sheldon, Brigham and Women's Hospital, Children's Hospital Boston; Elizabeth Gerard, Northwestern University; Laura Kalayjian, Keck School of Medicine of USC; Evan Gedzelman, Emory University School of Medicine; Jennifer Cavitt, University of Cincinnati; Patricia Penovich, Minnesota Epilepsy Group; and Eugene Moore, Emory University School of Medicine
Content: Rationale: The AAN-AES Pregnancy Parameter on management of women with epilepsy noted that stronger evidence is needed to determine obstetrical (OB) risks for pregnant women with epilepsy (PWWE) and neonatal (NN) risks for their children. Methods: The MONEAD study, i.e., Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (AEDs), is a prospective, observational, multi-center investigation of pregnancy outcomes for both the mother and child. Inclusion criteria included ages 14-45 years, < 20 weeks gestation. Exclusion criteria included history of psychogenic spells, IQ < 70, other major illness, progressive cerebral disease, and switching AEDs pre-enrollment. Primary aims for OB/NN outcomes were to determine if rates of C-section and small for gestational age (SGA) are increased in PWWE compared to healthy pregnant women (HPW). Secondary analyses were other complications, and if the rates differ among AEDs. SGA analyses only included singleton births. Comparisons were made via Fisher’s exact test between PWWE and HPW, between category of AED use (polytherapy vs combined monotherapy & no AEDs), and between types of monotherapy (lamotrigine (LTG) vs levetiracetam (LEV) vs Other (OMT)). Results: As of March 21, 2017, partial OB/NN data were available on 331 PWWE and 102 HPW. In PWWE, 248 subjects were on AED monotherapy, 68 polytherapy, and 15 no AEDs; 104 on LTG, 93 LEV, and 51 OMT. Data collection is still ongoing. C-section rates were 34.3% in PWWE and 27.1% in HPW. There were no differences between PWWE and HPW, or by AED group, or by specific AED monotherapy for C-section rate, pre-eclampsia, placental abruption, instrumental delivery, peripartum hemorrhage, and other major OB complications. However, preterm premature rupture of membranes (PPROM) did differ between AED categories with a higher rate in polytherapy (11.3%) vs. monotherapy/no AED (2.7%)(p=0.010). Higher non-significant premature delivery rates were observed in the polytherapy (16.2%) vs. monotherapy/no AED group (8.4%) (p=0.069). SGA rates were 4.3% in PWWE and 10.3% in HPW (p=0.051). There were no differences by AED category. There were differences across AED monotherapy: LTG (0%), LEV (4.3%), OMT (7.5%) (p=0.033), with 2 of 4 topiramate pregnancies resulting in SGA. NICU admission rates were higher in OMT (20.9%) compared to LTG (11.4%) and to LEV (5.6%), (p=0.045). Higher non-significant NICU rates were observed in polytherapy (21.7%) vs. monotherapy/no AED group (11.6%) (p=0.057). Conclusions: OB and NN outcomes did not differ between PWWE and HPW. Amongst PWWE, AED polytherapy subjects had higher PPROM rates. LTG and LEV monotherapy groups had lower SGA and NICU admission rates than the other monotherapies. Future analyses will include incorporation of important covariates (e.g., demographics, seizure types /frequency, AED concentrations). These preliminary findings suggest that the mode of delivery in PWWE should be chosen based on the same factors as HPW, and that particular AED regimens may negatively impact some OB and neonatal outcomes. Funding: National Institutes of Health, NINDS and NICHD #U01-NS038455.