How pregnancy and breastfeeding affect antiseizure medicines in moms and babies
Official title: Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding
Funded at University of Minnesota · NIH-11325799 · Data updated 2026-11-12
This grant aims to map how antiseizure drugs travel through a pregnant woman’s body and into a baby during pregnancy and breastfeeding to better tailor doses.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Minnesota NIH-funded |
| Lab location | 1 site (Minneapolis, United States) |
| Project start | August 4, 2021 |
| Project end | May 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $526,908 |
| NIH project number | 5R01HD105305-05 |
| Project ID | NIH-11325799 on NIH RePORTER |
Who could benefit from this research
✓Could help
Pregnant women with epilepsy and those who are breastfeeding who are on antiseizure medications, plus related clinical data from existing cohorts.
✕Less likely to help
People not using antiseizure medications or not pregnant/breastfeeding would not directly benefit.
What this research studies
Researchers will use physiology-based pharmacokinetic models to predict drug levels in mothers, fetuses, and breastfeeding infants. They will combine existing clinical data from the MONEAD study with animal and lab data to create and test models that reflect how pregnancy changes drug exposure. The goal is to guide safer, more effective dosing for pregnant women with epilepsy while protecting the developing baby. This work blends clinical information with lab studies to translate complex biology into tangible dosing recommendations. Results could lead to personalized treatment plans during pregnancy and lactation.
Why it matters
Potential benefit: If successful, this could help pregnant women with epilepsy maintain seizure control while reducing risks to their babies by guiding precise dosing.
How similar studies have gone: Previous studies have demonstrated the value of PBPK modeling in predicting drug exposure during pregnancy, with growing evidence supporting this approach.
Where this research is happening
-
University of Minnesota
Minneapolis, United States Active
Researchers
- Principal investigator: Birnbaum, Angela K — University of Minnesota
- Study coordinator: Birnbaum, Angela K
Related research
Other NIH-funded projects on the same topics.
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Understanding how antiseizure medications affect pregnant women and breastfeeding infants
This study is looking at how antiseizure medications affect pregnant women with epilepsy and their breastfeeding babies, aiming to find the best ways to keep both mom and baby healthy while managing seizures.
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.