Publication date: Mar 22, 2025

Pregnant women are often underrepresented in clinical trials. However, there is a growing push for more inclusion after multiple disease outbreaks, like COVID-19, Zika, and Mpox disproportionately affected them. Qualitative research has primarily focused on the experiences of pregnant women who choose to participate or decline participation in trials. To our knowledge, there has been no research on the perspectives of those who were excluded from trials upon becoming pregnant. To address this gap, we explored the views of women excluded from a phase 2 Ebola vaccine trial, as well as those of the broader community in Boende, Democratic Republic of the Congo. Through individual interviews and focus group discussions, we found that protecting the foetus was paramount for the women, leading to general acceptance of their exclusion from the trial. Trust in trial organisers’ knowledge, and the absence of an active Ebola outbreak at the time of the trial, may have supported this acceptance. Community perceptions generally aligned with those of the excluded women interviewed. However, the exclusion seemed to have impacted the decision to participate for a proportion of women of reproductive age. This was observed when some interviewed women reported declining participation in the trial due to their desire to conceive during the trial period. This study illustrates how women made pragmatic decisions regarding trial participation within the decision space available to them. Our findings seem to support established norms of special care for safety during pregnancy and echo sentiments described elsewhere in the literature. These results, coupled with the growing demands for the inclusion of pregnant women, highlight the necessity of finding a balance between prioritising the safety of women and their foetuses, and the autonomy of pregnant women, enabling them to make informed choices through comprehensible informed consent processes.

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Original Article