Abstracts

Rationale: Adverse neurodevelopmental effects of fetal antiepileptic drugs (AED) exposures have been demonstrated in animal and human studies. However, the effects can differ across AEDs and remain uncertain for most AEDs. Methods: The Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study is a prospective, observational, multi-center investigation of pregnancy outcomes for both the mother and child. Women with epilepsy (WWE) and healthy women (HW) were enrolled during pregnancy if they were ages 14-45 years and their pregnancy was <20 weeks gestational age. Exclusion criteria included history of psychogenic spells, IQ<70, other major medical illness, progressive cerebral disease, and switching AEDs pre-enrollment. Children were assessed at age 2 years using the Bayley Scales of Infant and Toddler Development-3 (BSID-III) yielding 5 Scale scores (i.e., Language, Motor, Cognitive, Social-Emotional, Adaptive Behavior). Preliminary analyses were conducted using ANCOVA models adjusting for maternal IQ. Results: Most PWWE enrolled in the study were on monotherapy (74%) and 80% of monotherapies were lamotrigine (LTG, 42% monotherapy) or levetiracetam (LEV, 38% monotherapy). Also 43% of the polytherapy were on dual therapy with LTG+LEV. BSID-III assessments were conducted in 287 children of WWE and 90 children of HW. There were no differences in children of WWE vs HW on any of the 5 BSID Scale scores (see Table 1). Children exposed to AED polytherapy had lower scores on 4 of the 5 Scale scores compared to AED monotherapy (see Table 2). LTG monotherapy, but not LEV, differed from AED polytherapy on Language and Motor Composite Scores after correcting for multiple comparisons. LTG and LEV did not differ on any measures. Conclusions: Overall, neurodevelopmental outcomes did not differ at age 2 years for children of WWE compared to those of HW. Children exposed to AED polytherapy did perform worse than those exposed to AED monotherapy. More detailed neuropsychological evaluations are planned for the children at later ages. Funding: National Institutes of Health, NINDS and NICHD #U01-NS038455.