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

Background

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.

Aim

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

Methods

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.

Results

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.

Conclusions

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.

Trial registration

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