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<p>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.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月15日

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  • Polyn Luz S. Pine,
  • Frederick Berro Rivera,
  • John Vincent U. Magalong,
  • Nathan Ross B. Bantayan,
  • Nicole Tesoro,
  • Chieh-Mei Tsai,
  • Martha Gulati

摘要

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.