Abstracts

Rationale: Antiepileptic drug (AED) utilization has changed over the last decade. This is a descriptive report of miscarriages and major congenital malformations (MCMs) in a contemporary cohort study. Methods: The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is a prospective, observational, multicenter investigation of pregnancy outcomes for both the mother and child. Inclusion criteria included ages 14-45 years, 20 weeks gestational age. Exclusion criteria included IQSecondary analyses reported here assessed miscarriages and MCMs. MCMs associated with a chromosomal abnormality were not included. Percentages are reported with Clopper-Pearson (Exact) 95% confidence intervals. Results: We enrolled 351 pregnant women with epilepsy (PWWE) and 105 healthy pregnant women (HPW). The most common AED monotherapy regimens were lamotrigine (n=109; 42% of 259 monotherapies), levetiracetam (n=97; 37%). The most common AED polytherapy combination was lamotrigine + levetiracetam (n=33; 43% of 77 polytherapies). Fifteen PWWE were on no AED. Spontaneous miscarriages occurred in 2.8% of PWWE and 0% in HPW. There were also 2 elective abortions in PWWE. Spontaneous miscarriages did not occur in the context of acute seizures, and no MCMs were reported in any of the miscarriages or elective abortions. The mean gestational ages at enrollment were 13.7 weeks in PWWE and 15.4 weeks in HPW. MCMs occurred in 18 (5.1%, 95% Confidence Intervals (CI): 3.1-8.0) of pregnancies in PWWE and 2 (1.9%, CI: 0.2-6.7) in HPW. MCMs were present in 14 (5.4%, CI: 3.0-8.9) of pregnancies on monotherapy, 3 (3.9%, CI: 0.8-11.0) on polytherapy, and 1 (6.7%, CI: 0.2-32.0) of PWWE on no AED. Tables 1 and 2 depict specific AEDs for miscarriages and MCMs. Conclusions: Although the sample is small, the results are consistent with prior observations of an increased risk of poor fetal outcomes in PWWE. However, the vast majority of pregnancies in PWWE had good outcomes. Funding: National Institutes of Health, NINDS and NICHD #U01-NS038455 and U01-NS050659