Salloum Maha, Larivière Ynke, Bikioli Bolombo Freddy, Zola Matuvanga Trésor, Lemey Gwen, Maketa Vivi, Muhindo-Mavoko Hypolite, Van Damme Pierre, Mitashi Patrick, Bastiaens Hilde, Van Geertruyden Jean-Pierre, Paviotti Antea
Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Antwerp, Belgium.
Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Antwerp, Belgium.
Vaccine. 2025 May 10;55:127000. doi: 10.1016/j.vaccine.2025.127000. Epub 2025 Mar 22.
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.
孕妇在临床试验中的代表性往往不足。然而，在新冠病毒、寨卡病毒和猴痘等多种疾病爆发后，越来越多的人呼吁增加孕妇在试验中的参与，因为这些疾病对她们的影响尤为严重。定性研究主要集中在选择参与或拒绝参与试验的孕妇的经历上。据我们所知，目前还没有关于那些在怀孕后被排除在试验之外的人的观点的研究。为了填补这一空白，我们探讨了被排除在一项埃博拉疫苗2期试验之外的女性以及刚果民主共和国博恩德更广泛社区的观点。通过个人访谈和焦点小组讨论，我们发现，对这些女性来说，保护胎儿至关重要，这导致她们普遍接受自己被排除在试验之外。对试验组织者知识的信任，以及试验期间没有埃博拉疫情爆发，可能支持了这种接受。社区的看法与接受采访的被排除女性的看法基本一致。然而，这种排除似乎影响了一部分育龄妇女参与试验的决定。这在一些接受采访的女性报告说，由于她们希望在试验期间怀孕，因此拒绝参与试验时得到了体现。这项研究说明了女性如何在她们可利用的决策空间内就试验参与做出务实的决定。我们的研究结果似乎支持了怀孕期间特别关注安全的既定规范，并呼应了文献中其他地方描述的观点。这些结果，再加上对纳入孕妇的需求不断增加，凸显了在优先考虑妇女及其胎儿的安全与孕妇的自主权之间找到平衡的必要性，使她们能够通过可理解的知情同意过程做出明智的选择。
