A qualitative study of clinicians’ perspectives on participating in an intrapartum randomised placebo-controlled trial for labour pain relief

TL;DR

This study explores midwives' experiences and challenges in a clinical trial testing a new labor pain relief treatment.

Contribution

The study provides insights into midwives' perspectives on conducting intrapartum placebo-controlled trials, highlighting unique challenges and motivations.

Findings

Midwives faced challenges in timing trial information and consent during labor.

Participants experienced mixed feelings about the placebo aspect of the trial.

Three key themes emerged: novel treatment introduction, care-placebo conflict, and trial participation experiences.

Abstract

Supporting intrapartum research through recruitment and intervention delivery and data collection can be challenging for clinical midwives. While there is a need for high-quality evidence of effective care during labour and birth, there are very few midwifery-led randomised controlled trials conducted during this period. Similarly, there is little research on the motivating factors and challenges for clinicians associated with intrapartum research.

Our aim was to explore the experiences of midwives who participated in a placebo-controlled intrapartum trial.

Midwives who had participated in a trial investigating the use of sterile water injections for managing abdominal labour pain were invited to participate. Semi-structured interviews were conducted via videoconferencing. Data were transcribed and analysed thematically.

Interviews were conducted with 11 midwives. Three themes were identified: (i) introducing a novel treatment for labour pain; (ii) the conflict of care and placebo and (iii) participating in a clinical trial.

Participants described experiences ranging from the support for an experimental analgesia and expectations of effect, to reservations to participants potentially encountering the placebo treatment. At times the experiences were both positive and negative. Midwives often found the timing of providing trial information and obtaining informed consent challenging. Our findings highlight the challenges encountered by midwives when presenting trial information, establishing equipoise and the timing for these to occur during labour.

The trial is registered at the Australian and New Zealand Clinical Trials Registry (Trial ID: ACTRN12621001036808). Registration date 5/08/2021.

The online version contains supplementary material available at 10.1186/s13063-025-09257-z.