U01HD118959
Cooperative Agreement
Overview
Grant Description
Optimal Dosing of Understudied Drugs Administered to Pregnant Individuals per Standard of Care (PREGDOSE) - Project Summary/Abstract
The majority of drugs prescribed to pregnant individuals lack dosing information specific to this population.
Dosing is different in this population due to anatomic and physiologic changes during pregnancy that substantially affect drug exposure.
A lack of appropriate dosing data in pregnant individuals is an unmet public health need that can result in therapeutic failure and maternal and fetal morbidity.
Our objective for the dosing and safety of understudied drugs administered to pregnant individuals per Standard of Care (PREGDOSE) study is to create the research infrastructure to address these dosing knowledge gaps and determine optimal dosing for commonly used drugs in pregnancy.
We will accomplish this goal through an integrated approach that is centered on a prospective, multi-center, opportunistic study of understudied drugs in pregnant individuals.
In Aim 1, we will enroll pregnant individuals who are on a drug(s) of interest per Standard of Care.
Biological samples and markers of drug efficacy will be collected throughout pregnancy and in the postpartum period.
Postpartum samples will also include cord blood and infant blood to better understand fetal/neonatal exposure.
Using an aliquot of each sample, in Aim 2 we will establish a biorepository to aid future precision-dosing studies.
In Aim 3 we will use sophisticated pharmacokinetic (PK)-pharmacodynamic (PD) modeling to determine optimal dosing.
This modeling will identify key determinants of drug exposure-effect to inform a pregnancy precision dosing tool.
The PIs and research team have a successful history in maternal pharmacology and possess the skills, access to patients, and research environment needed to complete these projects.
Dr. Rebecaa Clifton is a biostatistician, the PI of the Maternal-Fetal Medicine Units (MFMU) Data Coordinating Center and will oversee all study efforts.
Dr. Watt is a pediatrician, experienced trialist and pharmacologist, serves on the PRGLAC Implementation Working Group, and has led similar opportunistic dosing studies in children and lactating individuals.
Dr. Torri Metz is a maternal fetal medicine specialist with extensive experience in obstetric drug trials.
Importantly, this study will leverage the infrastructure and resources of the NICHD-funded MFMU network and Maternal and Pediatric Precision in Therapeutics (MPRINT) hub.
Key MPRINT co-investigators have the expertise and resources to develop the assays to measure drug concentrations (MOMPER), support the PK-PD modeling (Quinney, MOMPER, Bies), and develop the model-informed precision dosing tool (Quinney, Bies).
To maximize scientific exchange and accelerate research in the field, all information, data, protocols, resources, and methods developed by PREGDOSE will be shared through the MFMU and MPRINT hub and with the research and clinical community at large.
The majority of drugs prescribed to pregnant individuals lack dosing information specific to this population.
Dosing is different in this population due to anatomic and physiologic changes during pregnancy that substantially affect drug exposure.
A lack of appropriate dosing data in pregnant individuals is an unmet public health need that can result in therapeutic failure and maternal and fetal morbidity.
Our objective for the dosing and safety of understudied drugs administered to pregnant individuals per Standard of Care (PREGDOSE) study is to create the research infrastructure to address these dosing knowledge gaps and determine optimal dosing for commonly used drugs in pregnancy.
We will accomplish this goal through an integrated approach that is centered on a prospective, multi-center, opportunistic study of understudied drugs in pregnant individuals.
In Aim 1, we will enroll pregnant individuals who are on a drug(s) of interest per Standard of Care.
Biological samples and markers of drug efficacy will be collected throughout pregnancy and in the postpartum period.
Postpartum samples will also include cord blood and infant blood to better understand fetal/neonatal exposure.
Using an aliquot of each sample, in Aim 2 we will establish a biorepository to aid future precision-dosing studies.
In Aim 3 we will use sophisticated pharmacokinetic (PK)-pharmacodynamic (PD) modeling to determine optimal dosing.
This modeling will identify key determinants of drug exposure-effect to inform a pregnancy precision dosing tool.
The PIs and research team have a successful history in maternal pharmacology and possess the skills, access to patients, and research environment needed to complete these projects.
Dr. Rebecaa Clifton is a biostatistician, the PI of the Maternal-Fetal Medicine Units (MFMU) Data Coordinating Center and will oversee all study efforts.
Dr. Watt is a pediatrician, experienced trialist and pharmacologist, serves on the PRGLAC Implementation Working Group, and has led similar opportunistic dosing studies in children and lactating individuals.
Dr. Torri Metz is a maternal fetal medicine specialist with extensive experience in obstetric drug trials.
Importantly, this study will leverage the infrastructure and resources of the NICHD-funded MFMU network and Maternal and Pediatric Precision in Therapeutics (MPRINT) hub.
Key MPRINT co-investigators have the expertise and resources to develop the assays to measure drug concentrations (MOMPER), support the PK-PD modeling (Quinney, MOMPER, Bies), and develop the model-informed precision dosing tool (Quinney, Bies).
To maximize scientific exchange and accelerate research in the field, all information, data, protocols, resources, and methods developed by PREGDOSE will be shared through the MFMU and MPRINT hub and with the research and clinical community at large.
Funding Goals
NOT APPLICABLE
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Bethesda,
Maryland
208172843
United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 113% from $1,669,596 to $3,556,662.
George Washington University (The) was awarded
PREGDOSE Study: Optimizing Drug Dosing for Pregnant Individuals
Cooperative Agreement U01HD118959
worth $3,556,662
from the National Institute of Child Health and Human Development in August 2025 with work to be completed primarily in Bethesda Maryland United States.
The grant
has a duration of 4 years 9 months and
was awarded through assistance program 93.865 Child Health and Human Development Extramural Research.
The Cooperative Agreement was awarded through grant opportunity Multisite Clinical Research: Leveraging Network Infrastructure to Advance Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (U01 Clinical Trial Optional).
Status
(Ongoing)
Last Modified 7/6/26
Period of Performance
8/1/25
Start Date
5/31/30
End Date
Funding Split
$3.6M
Federal Obligation
$0.0
Non-Federal Obligation
$3.6M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for U01HD118959
Transaction History
Modifications to U01HD118959
Additional Detail
Award ID FAIN
U01HD118959
SAI Number
U01HD118959-3730743
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NT00 NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development
Funding Office
75NT00 NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development
Awardee UEI
ECR5E2LU5BL6
Awardee CAGE
4L405
Performance District
MD-08
Senators
Benjamin Cardin
Chris Van Hollen
Chris Van Hollen
Modified: 7/6/26