Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
Recruiting
Observational Study
Epilepsy
Pregnancy Related
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Study type
- Observational
- Participants needed
- 60 (estimated)
- Sponsor
- University of Pittsburgh · Other
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About This Trial
This project focuses on anti-seizure medication (ASM) clearance and physiological factors determining blood concentrations in pregnant adult women with epilepsy and amounts of exposure to their unborn children and nursing infants.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Woman with epilepsy between the ages of 18-45 planning pregnancy or in the early first trimester of pregnancy.
* Women with epilepsy ability to maintain a daily medical diary
* Women with epilepsy ability to answer side effect questionnaires
* Women with epilepsy currently bei…