# Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)

> **NIH NIH U01** · STANFORD UNIVERSITY · 2021 · $2,576,269

## Abstract

Project Summary:
There is a compelling need for prospective, properly controlled studies in women with epilepsy (WWE) during
pregnancy to improve maternal and child outcomes. The proposed investigations are pertinent to the NINDS
Epilepsy Research Benchmarks, address multiple gaps in our knowledge noted by the American
Academy of Neurology, and transform care in WWE. This multicenter investigation employs a prospective, observational,
parallel-group, cohort design with an established research team. The FDA requires animal testing of individual AEDs to
detect risks of fetal exposure for anatomical teratogenesis (i.e., congenital malformation), but not for functional
teratogenesis (i.e., cognitive and behavioral deficits). Further, multiple human AED pregnancy registries are investigating
malformations, but not cognitive/behavioral outcomes. Determining the effects of fetal AED exposure on development of
neuropsychological abilities requires prospective collection of potential confounding factors and testing of children years
after exposure. Thus, it is not surprising that such studies are rare, and the risks for most AEDs have not been assessed.
The MONEAD investigation provides a unique cohort of exposed and unexposed children who have been followed
prospectively starting in early pregnancy with detailed data collection; MONEAD is the first study to assess the effects of
quantitated AED-exposure on neurodevelopment during pregnancy and breastfeeding by directly assessing blood levels in
mother, cord blood and infant. This is critical because several commonly used AEDs undergo marked clearance changes
during pregnancy with marked individual variability in these changes. Such changes could obscure “dose” relationships
reducing sensitivity of detecting adverse effects. MONEAD is also collecting data on the effects of breastfeeding while
taking AEDs which includes blood levels in the child and a breastfeeding diary to directly delineate their exposure. This
has never been done previously. The collection of AED levels and other pregnancy related factors is complete. In the
proposed continuation grant, the children will undergo detailed neuropsychological testing at 2, 3, 4.5, and 6 years-old.
The results will provide clear indications of AED risks to the immature brain for the presently most commonly used
AEDs, and provide sentinel data on less commonly used AEDs to direct future studies.
 The Specific Aims are to determine the long-term effects of in utero and infant AED exposure in the children of
WWE on: Aim 1: Cognitive outcomes (e.g., verbal abilities and other cognitive domains including novel measures of
cerebral lateralization and creativity), Aim 2: Behavioral outcomes (e.g., adaptive and emotional/behavioral functioning,
with measures of autistic behavior, attentional problems and hyperactivity), Aim 3: Determine if breastfeeding when
taking AEDs adds additional risks. Hypotheses: Children exposed in utero to certain AEDs will exhibit concen...

## Key facts

- **NIH application ID:** 10131272
- **Project number:** 5U01NS038455-19
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** KIMFORD J MEADOR
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $2,576,269
- **Award type:** 5
- **Project period:** 2000-09-30 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10131272

## Citation

> US National Institutes of Health, RePORTER application 10131272, Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) (5U01NS038455-19). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10131272. Licensed CC0.

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