# Maternal epilepsy, antiepileptic drug use during pregnancy, and risk of autism

> **NIH NIH R01** · DREXEL UNIVERSITY · 2022 · $404,016

## Abstract

Project Abstract
In a multi-national epidemiological study in Sweden and the United Kingdom, we aim to study if maternal
epilepsy and use of anti-epileptic drugs (AEDs) during pregnancy is associated with increased risk of autism
spectrum disorders (ASD). In addition, we will examine maternal health outcomes associated with AED use to
provide data regarding the risk-benefit ratio of continuing medication use during pregnancy. Epilepsy is the
most common serious neurological disorder affecting women during pregnancy, and is linked with a 10-fold
increased risk of death during delivery. Antiepileptic drugs are necessary for seizure control, but effects of AED
use during pregnancy remain understudied. Although there is good evidence linking use of AEDs during
pregnancy to congenital malformations, there is less high-quality evidence concerning adverse
neurodevelopmental outcomes. Two studies have found an association between AED exposure during
pregnancy and ASD, but both studies had fewer than 10 ASD cases exposed to AEDs. Moreover, many
studies of AEDs and neurodevelopmental outcomes have methodological issues. Two review of past studies of
neurodevelopmental outcomes in children exposed to AEDs found substantial problems that prevented
definitive conclusions regarding adverse effects of AED exposure. The chief problems included: confounding,
selection bias, and small sample sizes with limited statistical power. We propose an epidemiological study that
addresses each of these issues, in a combined sample of nearly 3 million children born in Sweden and the
United Kingdom.
All exposure, confounder, and outcome data are derived from clinical and population databases in Sweden and
the UK. In Aim 1 we will estimate associations of maternal epilepsy and child ASD. In Aim 2, we evaluate the
safety of AED use and of specific AEDs during pregnancy with regard to child ASD. In Aim 3, we will estimate
the risk or risk reduction of pregnancy and delivery outcomes associated with AED use during pregnancy, such
as seizure, self-harm, or death. Throughout all analyses, causal inference techniques will be employed to
determine the validity of findings. Methods include propensity score matching, sibling and negative controls,
and simulation of unobserved confounders.

## Key facts

- **NIH application ID:** 10444997
- **Project number:** 5R01NS107607-04
- **Recipient organization:** DREXEL UNIVERSITY
- **Principal Investigator:** Brian Kane Lee
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $404,016
- **Award type:** 5
- **Project period:** 2019-06-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10444997

## Citation

> US National Institutes of Health, RePORTER application 10444997, Maternal epilepsy, antiepileptic drug use during pregnancy, and risk of autism (5R01NS107607-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10444997. Licensed CC0.

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