NIH-funded research U01 cooperative agreement

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.

More Pregnant Women research and trials

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionGeorge Washington University
NIH-funded
Lab location1 site (Washington, United States)
Project startAugust 1, 2025
Project endMay 31, 2030
Funding year2026
Award (this year)$1,887,066
NIH project number5U01HD118959-02
Project IDNIH-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

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.