Women’s and clinician’s acceptability of participation in a hypothetical obstetric randomized controlled trial: a qualitative survey

Abstract

Background

Involving patients and consumers in research design helps ensure relevance for those affected by the problem being investigated and can optimize recruitment to clinical trials. This is particularly important when conducting research involving pregnant women.

Aims

We investigated women’s motivations to participate in a hypothetical randomized control trial (RCT) of a third-trimester screening test for intrapartum fetal compromise (IFC) and adverse perinatal outcomes.

Materials and methods

Women attending for routine antenatal care at a tertiary center were invited to complete a short, anonymized patient acceptability survey. The survey was developed with the assistance of the Perinatal Society of Australia and New Zealand’s Consumer Advisory Panel and consisted of Likert scales and open-ended questions. It was designed to ascertain women’s responses to research issues, particularly the acceptability of being randomized to a non-revealed arm of a screening test RCT.

Results

100 pregnant women took part; 40% indicated that they would agree/strongly agree to participate in a hypothetical RCT regardless of whether they were given the result of a screening test and 31% were unsure. Randomization to either an intervention or control group was acceptable to 47%, 30% were unsure and 23% were not willing to be randomized. Reasons to participate included the desire to contribute to research and to improve pregnancy care.

Conclusions

Participation in an RCT of a screening test for IFC involving non-disclosure of the test result was acceptable to a large minority of pregnant women. This finding supports the feasibility of conducting a large-scale study of this design.

Keywords:

• Patient acceptability
• obstetric research
• randomized controlled trial
• RCT

Acknowledgments

The authors acknowledge research funding from the National Health and Medical Research Council (NHMRC), Australia and the Mater Foundation. The funders had no involvement in the design, conduct, analysis of or decision to publish this study.

Disclosure statement

No potential conflict of interest was reported by the author(s).