ArticleWomen's health issues : official publication of the Jacobs Institute of Women's Health
Exclusion of Reproductive-aged Women in COVID-19 Vaccination and Clinical Trials.
Article in Women's health issues : official publication of the Jacobs Institute of Women's Health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.
- Systematic Review of Avian Influenza Virus Infection and Outcomes during Pregnancy.Emerging infectious diseases · 2025Pooled it
- Exclusion by Design: Regulatory Reform and Evolving Frameworks for Clinical Trials in Pregnancy.Paediatric drugs · 2026Review
- Living with risk and uncertainty: a qualitative phenomenological study of women's pregnancy and postpartum experiences in Saskatchewan during COVID-19.BMC pregnancy and childbirth · 2026Article
- Perceptions of COVID-19 Vaccination During Pregnancy in a Cohort of US Adults (CHASING COVID) in 2023.medRxiv : the preprint server for health sciences · 2026Article
- Gender Diversity of Research Teams and Clinical Trial Enrollment.JAMA network open · 2025Article
- Changes in prenatal cannabis use and perceptions during the COVID-19 pandemic.Drug and alcohol dependence reports · 2025Article
- Strategies to promote contraception use by female volunteers in Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease (API ADAD) Colombia trial.Clinical trials (London, England) · 2025Article
- Motivation to Clinical Trial Participation: Health Information Distrust and Healthcare Access as Explanatory Variables and Gender as Moderator.Journal of clinical medicine · 2025Article
- The inclusion of pregnant women in research during disease outbreaks globally: A scoping review.Revista latino-americana de enfermagem · 2025Article
- Exploring COVID-19 vaccine attitudes among pregnant women: key factors and strategies to enhance uptake.npj women's health · 2025Article
- Article
- COVID-19 clinical trial participation and awareness in Texas.Human vaccines & immunotherapeutics · 2024Article
- SARS-CoV-2, Tdap, and influenza vaccination during pregnancy from 2019 to 2022 in Ontario, Canada: a population-based retrospective cohort study.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2024Article
- Lack of association between COVID-19 vaccines and miscarriage onset using a case-crossover design.Scientific reports · 2024Article
- Impact of national pandemic policies on maternal health.BMJ medicine · 2024Article
- Data-driven insights can transform women's reproductive health.npj women's health · 2024Review
- Article
- Factors that impact on recruitment to vaccine trials in the context of a pandemic or epidemic: a qualitative evidence synthesis.The Cochrane database of systematic reviews · 2023Review
- Monoclonal Antibody Therapy of Breastfeeding Patient Infected with SARS-CoV-2: A Case Report.Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine · 2023Article
- Vaccination and treatment options for SARS-CoV2 infection affecting lactation and breastfeeding.Seminars in fetal & neonatal medicine · 2023Review
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWe analyzed the exclusion of pregnant and breastfeeding individuals and those capable of pregnancy in COVID-19 vaccine and clinical treatment trials.
methodsInclusion and exclusion criteria were extracted from all listed COVID-19 vaccine and treatment clinical trials from May 1, 2020, to October 31, 2020, using the U.S. National Library of Medicine database. We report rates of rates of exclusion for pregnant and lactating individuals and requirements for contraception for pregnancy-capable participants in COVID-19 vaccine and treatment clinical trials. The analysis included the association between clinical trial exclusion and vaccine and treatment type, study location, sponsor, and phase.
resultsPregnant and lactating individuals were explicitly excluded from most COVID-19 vaccine and treatment clinical trials. Of the 90 vaccine trials, 88 (97.8%) excluded pregnant individuals, 73 (81.1%) excluded lactating individuals, and 56 (62.2%) required contraception use. Of the 495 treatment trials, 350 (70.7%) excluded pregnant individuals, 269 (54.3%) excluded lactating individuals, and 91 (18.4%) required contraception use. Although vaccine type was not associated with pregnancy exclusion, it was associated with lactation exclusion (p = .01) and contraception requirement (p < .001). Treatment type was associated with pregnancy exclusion, lactation exclusion, and contraception requirement (all p < .001).
conclusionsCOVID-19 vaccination and treatment clinical trials mirrored historical trends restricting participation owing to pregnancy, lactation, and contraception nonuse, despite known safety profiles. People of childbearing potential should be considered for and afforded the same opportunity as males to make informed decisions on study participation, particularly in the setting of a global pandemic.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.