To address the burden of maternal morbidity and mortality in low‐ and middle‐income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC‐context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle‐income setting. This qualitative research used participant observation, in‐depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision‐making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context‐specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner.

Background The uneven global and national distribution of obstetric fistulas suggests a complex network of determinants contributing to fistula development. This study aims to create an understanding of the determinants of obstetric fistula in Uganda and to give a framework for health policy improvement. Methods A scoping review of existing literature was performed, searching the PubMed/MEDLINE database, Ugandan Demographic and Health Surveys, and official sources of Ugandan statistics. Data was analysed using the model for the determinants of health by Dahlgren and Whitehead. Results Obstetric fistulas are associated with different personal lifestyle factors, certain social and community networks, as well as poor working and living conditions. Malnutrition, early childbearing, limited female empowerment, lack of awareness of childbearing risks, low socioeconomic status, and long distances to emergency obstetric care play a part. Certain regions of Uganda are in particular associated with obstetric fistula, where an accumulation of determinants is notable. Conclusion Analysis using the model of Dahlgren and Whitehead shows that obstetric fistulas are associated with determinants at different levels of society. Poverty and low education link these in a web that is disproportionately hard to escape from for the poorest women. This inequity asks for co-operation between ministries to dismantle the environment for obstetric fistula.

An amendment to this paper has been published and can be accessed via the original article.