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Poster Session 2

Category: Health Equity/Community Health

Poster Session 2

(549) Quantifying the evidence gap: Assessing the exclusion of pregnant and lactating persons from clinical trials

Wednesday, February 11, 2026

3:30 PM - 5:00 PM

Submitting Author and Presenting Author(s)

Kelsey C. Mumford, MD (she/her/hers)

Resident Physician
Johns Hopkins Hospital
Baltimore, Maryland, United States

Coauthor(s)

CP

Caleigh Propes, BA

PhD Candidate
Johns Hopkins Berman Institute of Bioethics
Baltimore, Maryland, United States
SM

Stephanie Morain, MPH, PhD

Associate Professor
Johns Hopkins University
Baltimore, Maryland, United States
AL

Anne Lyerly, MA, MD

Research Professor in Obstetrics and Gynecology
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
RF

Ruth R. Faden, MA, MPH, PhD

Professor
Johns Hopkins University
Baltimore, Maryland, United States
JS

Jeanne Sheffield, MD

Director of the Division of Maternal-Fetal Medicine
Johns Hopkins Hospital
Baltimore, Maryland, United States

Objective:
In 2018, the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) reported their recommendations to address the gaps in research on safe and effective therapies for pregnant and lactating women. Despite these recommendations, we hypothesized that these populations continue to be unjustifiably excluded from most clinical trials in the United States.

Study Design:
A search of phase IV clinical trials and observational studies from 2020-2024 related to four common conditions affecting pregnant and lactating persons (hypertension, diabetes mellitus, anxiety/depression, and HIV/AIDS) was performed using ClinicalTrials.gov. Each study that excluded pregnant or lactating persons was independently evaluated by two reviewers and assigned a risk category of minimal risk, substantial risk, or acceptable to include pregnant or lactating p</span>ersons on a case-by-case basis. Statistical analysis included use of Pearson’s chi-square with statistical significance set at P< 0.05.

Results:
206 phase IV clinical trials and 550 observational studies met inclusion criteria and were reviewed. Pregnant and lactating persons were explicitly excluded from 138 (67%) of phase IV and 256 (47%) of observational studies. Of the exclusionary phase IV studies, 65 (47%) were classified as posing substantial risk to pregnant persons and 26 (27%) to lactating persons. Of the exclusionary observational studies, 28 (12%) posed substantial risk to pregnant persons and 7 (6%) to lactating persons. Risk classifications were found to significantly differ according to chronic disease category (Table 1).

Conclusion:
Even when looking at phase IV and observational studies for established medications concerning the most common chronic conditions experienced by pregnant and lactating persons, they are still being unnecessarily systematically excluded from clinical trials. These data emphasize that despite the PRGLAC task force's warning about the detrimental effects this has for both these populations and their fetuses/newborns, the dearth of data on medications and therapies is not set to be rectified anytime soon.