Participating in a trial in a critical situation: a qualitative study in pregnancy

Abstract

Background: Randomised controlled trials of interventions in critical situations are necessary to establish safety and evaluate outcomes. Pregnant women have been identified as a potentially vulnerable population.

Objective: To explore women's experiences of being recruited to ORACLE, a randomised controlled trial of antibiotics in pre-term labour.

Methods: Twenty qualitative interviews were conducted with women who had participated in ORACLE. Analysis was based on the constant comparative method.

Results: Women gave prominence to the socioemotional aspects of their interactions with healthcare professionals in making decisions on trial participation. Comments on the quality of written and spoken information were generally favourable, but women's accounts suggest that the stressful nature of the situation affected their ability to absorb the information. Women generally had poor understanding of trial design and practices. The main motivation for trial participation was the possibility of an improved outcome for the baby. The second and less prominent motivation was the opportunity to help others, but this was conditional on there being no risks associated with trial participation. In judging the risks of participation, women seemed to draw on "common sense" understandings including a perception that antibiotics were risk free.

Discussion: Recruitment to trials in critical situations raises important questions. Future studies should explore how rigorous governance arrangements for trials, particularly in critical situations, can protect participants rather than relying on ideals of informed consent that may be impossible to achieve. Future research should include a focus on interactions between research candidates and professionals involved in recruitment.