Optimal Dosing for Pregnant Women: Guiding Better Medicines for Mom and Baby
Official title: Optimal Dosing of Understudied Drugs Administered to Pregnant Women per Standard of Care (PregDose)
Funded at George Washington University · NIH-11388649 · Data updated 2026-11-12
A multi-center study aims to figure out the best dosing for drugs commonly used in pregnancy to keep both mom and baby safe and effective.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | George Washington University NIH-funded |
| Lab location | 1 site (Washington, United States) |
| Project start | August 1, 2025 |
| Project end | May 31, 2030 |
| Funding year | 2026 |
| Award (this year) | $1,887,066 |
| NIH project number | 5U01HD118959-02 |
| Project ID | NIH-11388649 on NIH RePORTER |
Who could benefit from this research
✓Could help
Pregnant women who are currently taking drugs of interest as part of standard medical care.
✕Less likely to help
Pregnant women not using any of the understudied drugs or not enrolling in the predefined cohorts may not benefit.
What this research studies
This project will enroll pregnant women taking drugs as part of their standard care and collect biological samples throughout pregnancy and after birth, including cord blood and infant blood, to understand how pregnancy changes drug exposure. The team will build a biorepository from these samples to support future precision-dosing research. Advanced pharmacokinetic and pharmacodynamic modeling will be used to determine optimal dosing for these drugs during pregnancy. The study seeks to address a critical gap where current dosing information for pregnant women is often lacking. The overall goal is to improve maternal and fetal outcomes by informing better dosing guidelines.
Why it matters
Potential benefit: If successful, this work could lead to more accurate dosing guidelines for pregnant patients, reducing therapeutic failures and minimizing risks to both mother and baby.
How similar studies have gone: Previous similar efforts have shown that PK-PD modeling can improve dosing decisions for special populations, with this study extending that work to pregnancy.
Where this research is happening
-
George Washington University
Washington, United States Active
Researchers
- Principal investigator: Clifton, Rebecca Gersnoviez — George Washington University
- Study coordinator: Clifton, Rebecca Gersnoviez
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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.