The experiences of pregnant women in an interventional clinical trial: Research In Pregnancy Ethics (RIPE) study

Abstract

There is increasing global pressure to ensure that pregnant women are responsibly and safely included in clinical research in order to improve the evidence base that underpins healthcare delivery during pregnancy. One supposed barrier to inclusion is the assumption that pregnant women will be reluctant to participate in research. There is however very little empirical research investigating the views of pregnant women. Their perspective on the benefits, burdens and risks of research is a crucial component to ensuring effective recruitment. The Research In Pregnancy Ethics (RIPE) study set out to ascertain the views of pregnant women about research participation using an inductive thematic analysis. We conducted semi-structured interviews with 20 women who had participated in a double-blind randomised placebo controlled trial in Wellington (New Zealand) while pregnant. Our results show that at least some pregnant women recognise the value and importance of research during pregnancy. The women we interviewed were deeply invested in the research process and outcomes. Key motivations for participating were altruism, playing a valuable civic role and the importance of research. The main perceived burdens related to inconvenience and time commitment. For some women, possible randomization to the placebo arm was regarded as a burden or disadvantage.

An exploration of women's experience of taking part in a randomized controlled trial of a diagnostic test during pregnancy: A qualitative study

“…The prospect of an additional blood test, with its potential of earlier identification and diagnosis of a clinical complication, was an incentive for our study. Others have similarly reported a sense of civic duty, the opportunity to help others and the possibility of an improved outcome for their baby to be driving forces behind participation . A Brazilian group reported the main motivator to comprise access to free medicine and an opportunity to engage with health‐care providers .…”

“…In our study, those randomized to the intervention felt participation in the trial directly benefited their pregnancy, with the additional test providing valuable information on placental functioning and the perception of increased care from clinicians. On reviewing the literature, we identified limited numbers of previous studies examining women's experience of participation in a RCT while pregnant . These RCTs vary in terms of design and methodology, frequently involved administration of a medicinal product or a placebo.…”

“…We employed a qualitative study design, using semi‐structured interviews, to explore women's views, experience and beliefs regarding pregnancy research. A semi‐structured topic guide was developed based on existing literature . Qualitative research has been utilized for many years to provide insight into problems, help develop hypotheses and to gain an understanding of underlying reasons, opinions and motivations .…”

Stop, think, reflect, realize—first‐time mothers’ views on taking part in longitudinal maternal health research

“…The main barriers related to the survey(s) being long, being too busy as a first‐time mother to complete them on time and questions being intimate or repetitive. While others have identified lack of time or inconvenience as being a barrier to both recruitment and retention to intervention studies or trials, many women in this study completed a lengthy survey with intimate questions during the early stages of pregnancy, despite experiencing sickness or pregnancy‐related worries. Nevertheless, their comments identify potential barriers to recruiting participants in longitudinal studies during pregnancy.…”

“…While cohort studies can fulfil the interests of researchers, policy makers and clinicians, participants are seldom listed as beneficiaries. Studies have shown that some pregnant women take part in research, by completing questionnaires or enrolling in randomized trials, for altruistic reasons . For some, taking part in research enhanced their personal experience or made them feel special while others felt it had the potential to be a negative experience .…”