ArticleReproductive health2017
Protected to death: systematic exclusion of pregnant women from Ebola virus disease trials.
Article in Reproductive health, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Ebola virus disease in pregnancy: a systematic review and meta-analysis.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2022Pooled it
- Heterologous two-dose Ebola vaccine regimen in pregnant women in Rwanda: a randomized controlled phase 3 trial.Nature medicine · 2025Trial
- Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial.The Lancet. Infectious diseases · 2022Trial
- Women's right to science and health: 30 years on, progress and gaps remain.International health · 2026Article
- Article
- Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.BMJ public health · 2026Article
- Protecting pregnancy during pandemics: What recent outbreaks teach us.Human vaccines & immunotherapeutics · 2025Review
- Beyond COVID-19, the case for collecting, analysing and using sex-disaggregated data and gendered data to inform outbreak response: a scoping review.BMJ global health · 2025Article
- The inclusion of pregnant women in research during disease outbreaks globally: A scoping review.Revista latino-americana de enfermagem · 2025Article
- Ethics in humanitarian settings-relevance and consequences for dialysis and kidney care.Clinical kidney journal · 2024Review
- Article
- Maternal and perinatal health research during emerging and ongoing epidemic threats: a landscape analysis and expert consultation.BMJ global health · 2024Article
- Article
- Increased risk of severe COVID-19 in pregnancy in a multicenter propensity score-matched study.Journal of perinatal medicine · 2023Review
- Research ethics during infectious disease outbreaks: A survey of African research stakeholders using the Ebola virus disease outbreak as a case.Journal of public health in Africa · 2023Article
- Common pathways targeted by viral hemorrhagic fever viruses to infect the placenta and increase the risk of stillbirth.Placenta · 2023Article
- Teratology research in the shadow of the Dobbs decision.Birth defects research · 2023Article
- Identifying the scope of ethical challenges caused by the Ebola epidemic 2014-2016 in West Africa: a qualitative study.Philosophy, ethics, and humanities in medicine : PEHM · 2022Article
- Article
- Vaccine regulation should require and enforce the inclusion of pregnant and breastfeeding women in prelicensure clinical trials.Human vaccines & immunotherapeutics · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundFor 30 years, women have sought equal opportunity to be included in trials so that drugs are equitably studied in women as well as men; regulatory guidelines have changed accordingly. Pregnant women, however, continue to be excluded from trials for non-obstetric conditions, though they have been included for trials of life-threatening diseases because prospects for maternal survival outweighed potential fetal risks. Ebola virus disease is a life-threatening infection without approved treatments or vaccines. Previous Ebola virus (EBOV) outbreak data showed 89-93% maternal and 100% fetal/neonatal mortality. Early in the 2013-2016 EBOV epidemic, an expert panel pointed to these high mortality rates and the need to prioritize and preferentially allocate unregistered interventions in favor of pregnant women (and children). Despite these recommendations and multiple ethics committee requests for their inclusion on grounds of justice, equity, and medical need, pregnant women were excluded from all drug and vaccine trials in the affected countries, either without justification or on grounds of potential fetal harm. An opportunity to offer pregnant women the same access to potentially life-saving interventions as others, and to obtain data to inform their future use, was lost. Once again, pregnant women were denied autonomy and their right to decide.
conclusionWe recommend that, without clear justification for exclusion, pregnant women are included in clinical trials for EBOV and other life-threatening conditions, with lay language on risks and benefits in information documents, so that pregnant women can make their own decision to participate. Their automatic exclusion from trials for other conditions should be questioned.
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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.