Repeated hands-and-knees positioning during labour shows feasibility for larger trial, informs sample size

Optimal birthing positions are crucial for facilitating vaginal delivery and potentially reducing the need for interventions. Labour dystocia, or difficult labour, remains a significant challenge, often leading to prolonged labour and increased rates of cesarean section (CS). Current standard care often involves supine or semi-recumbent positions, which can restrict pelvic outlet dimensions and hinder fetal descent. Exploring alternative positions, such as hands-and-knees, could offer a non-pharmacological approach to improve labour progression and maternal-neonatal outcomes by optimizing pelvic mechanics and alleviating pressure.

Investigators conducted a pilot randomized controlled trial (RCT) to evaluate the feasibility and acceptability of repeated hands-and-knees positioning during labour. The study enrolled 20 participants (NCT ID: NCT04056793). Key objectives included estimating enrollment rates, assessing compliance with the study protocol by both participants and care providers, and gathering women's perspectives on their experiences with the position. Crucially, the trial also aimed to provide preliminary estimates of treatment effects to inform the sample size calculation for a future, larger definitive trial, ensuring robust statistical power.

The pilot trial successfully met its objectives, providing essential data to inform the design of a larger, definitive study. Researchers were able to estimate enrollment rates and assess the practical aspects of implementing repeated hands-and-knees positioning within a clinical labour setting. Compliance with the study protocol was evaluated for both the birthing individuals and healthcare providers, indicating the operational viability of the intervention. Women's views regarding their experiences with the hands-and-knees position were obtained, offering qualitative insights into acceptability and comfort. While specific numerical treatment effects were not the primary outcome of this pilot, the study successfully generated preliminary estimates.

These estimates are critical for calculating the appropriate sample size for a subsequent large-scale trial, ensuring it is adequately powered to detect statistically significant differences in labour interventions and maternal/neonatal outcomes.