Abstract
Background: Research in pregnancy and childbirth is required to advance healthcare needs for this population. Fears around potential fetal risk and the history of drug scandals renders it an area of research that is somewhat neglected. Due to the growing medical complexities facing pregnant women, efforts have been made in recent times to recognise the ethical importance of including this population in clinical research.Although clinical trials are becoming more common in pregnancy, recruitment of this population remains difficult with a common assumption that pregnant women would be reluctant to participate in clinical trials. This study set out to explore pregnant women's perspectives and experiences of the decision-making process to participate in a randomised controlled trial of metformin in gestational diabetes mellitus (the EMERGE clinical trial). Methods: This study employed a qualitative descriptive design with thematic analysis. Data were collected by conducting individual semi-structured interviews (n=11) with participants (n=9) and decliners (n=2) of the EMERGE clinical trial. Results: The main findings reveal that a significant perception of personal benefit from participation was the biggest influence on women's decisions to participate. Concerns about the impact of gestational diabetes on their pregnancies, the option of a favourable intervention treatment, a low perception of risk associated with the trial and the opportunity to help medical research appeared to have significantly influenced their decision. Receiving detailed information, personal interactions with the study team, a perception of voluntariness in participation and accessibility of the trial positively impacted on women's decisions to participate. Conclusions: Personal contact during recruitment, presenting clear and thorough trial information, providing previous participant testimonials, and facilitating women to participate in clinical trials are all important strategies when trying to enhance recruitment in pregnancy trials. Further research on pregnant women declining participation in clinical trials is needed.
Highlights
Pregnant women were excluded from research as they were thought of as a vulnerable population in need of protecting from the dangers of research (Ballantyne et al, 2017; Matsui, 2015)
Planning study visits around standard care visits was highlighted by Salazar et al (2016) as a means of improving recruitment and retention in clinical trials, and evidence from this study suggests it is an important aspect of trial conduct to consider when planning clinical trials in pregnancy
This is encouraging, recruitment of pregnant women into clinical trials remains challenging for researchers and recruitment rates appear to be consistently low in pregnancy trials (Strömmer et al, 2018)
Summary
Pregnant women were excluded from research as they were thought of as a vulnerable population in need of protecting from the dangers of research (Ballantyne et al, 2017; Matsui, 2015). Pregnancy was often deemed an automatic exclusion criterion for clinical trials (Matsui, 2015) Main reasons for their exclusion were often related to the classification of pregnant women as a vulnerable population, fear of causing harm to the fetus and doubts whether pregnant women would participate in clinical research (Blehar et al, 2013). Concerns about lack of evidence regarding safety and unknown risks to the fetus are often reasons why drug companies, institutional review boards and researchers remain reluctant to include pregnant women in clinical trials (Allesee & Gallagher, 2011; Matsui, 2015). Concerns about the impact of gestational diabetes on their pregnancies, the option of a favourable intervention treatment, a low perception of risk associated with the trial and the opportunity to help medical research appeared to have significantly influenced their decision.
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