Enrollment of all-female and lactating or pregnant female participants in cardiovascular trials

Cardiovascular disease remains the leading cause of mortality among women globally, yet females, particularly those who are pregnant or postpartum, remain underrepresented in cardiovascular clinical trials. This study assessed enrollment trends of all-female participants, including pregnant and postpartum women, in cardiovascular trials registered on ClinicalTrials.gov from 2017 to 2023. Among the trials identified, there was no significant increase in studies exclusively enrolling women or those focused on pregnancy and postpartum populations. Most trials targeted obesity (58%) and hypertension (26%) in women aged 19-55 and were predominantly sponsored by universities in the United States. Interventions were largely limited to lifestyle and pharmacologic strategies. The lack of growth in inclusive trial design underscores persistent research gaps. Greater efforts are needed across policy, funding, and trial design to ensure equitable representation of all women, particularly during vulnerable physiological stages such as pregnancy and lactation, to improve evidence-based cardiovascular care.

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Publication Details

Journal
npj Cardiovascular Health
Published
2025-09-15
DOI
https://doi.org/10.1038/s44325-025-00084-4
Citations
1
Primary Topic
Sex and Gender in Healthcare
Type
article
Field-Weighted Citation Impact
1.88
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article

Enrollment of all-female and lactating or pregnant female participants in cardiovascular trials

Chieh-Mei Tsai, Nathan Ross B. Bantayan, Martha Gulati, John Vincent Magalong et al.
1 citations
npj Cardiovascular Health
Sex and Gender in Healthcare
1.88
article

Enrollment of all-female and lactating or pregnant female participants in cardiovascular trials

Chieh-Mei Tsai, Nathan Ross B. Bantayan, Martha Gulati, John Vincent Magalong, Frederick Berro Rivera, Polyn Luz S Pine, Nicole Ann Tesoro
article en
1 citations

Abstract

Cardiovascular disease remains the leading cause of mortality among women globally, yet females, particularly those who are pregnant or postpartum, remain underrepresented in cardiovascular clinical trials. This study assessed enrollment trends of all-female participants, including pregnant and postpartum women, in cardiovascular trials registered on ClinicalTrials.gov from 2017 to 2023. Among the trials identified, there was no significant increase in studies exclusively enrolling women or those focused on pregnancy and postpartum populations. Most trials targeted obesity (58%) and hypertension (26%) in women aged 19-55 and were predominantly sponsored by universities in the United States. Interventions were largely limited to lifestyle and pharmacologic strategies. The lack of growth in inclusive trial design underscores persistent research gaps. Greater efforts are needed across policy, funding, and trial design to ensure equitable representation of all women, particularly during vulnerable physiological stages such as pregnancy and lactation, to improve evidence-based cardiovascular care.

npj Cardiovascular HealthVol. 2(1)
New York City Health and Hospitals Corporation (US), Mayo Clinic (US), Princess Royal University Hospital (GB), San Beda University (PH), Cedars-Sinai Smidt Heart Institute (US)
Openalex Percentile: Top 12%
Sex and Gender in Healthcare
1.88
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Enrollment of all-female and lactating or pregnant female participants in cardiovascular trials — Chieh-Mei Tsai, Nathan Ross B. Bantayan, et al. · npj Cardiovascular Health (2025) | TGRS Research Map | TGRS