Membrane sweeping for induction of labour: The MILO Study

Post-term pregnancy refers to a pregnancy that continues past 42 weeks? gestation. It occurs in approximately 10% of pregnancies and is the most common reason for induction of labour. Post-term pregnancy is associated with higher risk of trauma to mother and baby. Membrane sweeping is a simple procedure potentially promoting the onset of spontaneous labour, reducing the number of women requiring induction to avoid post-term pregnancy. However, we do not know the best time during pregnancy or how often we need to perform a membrane sweep. We also do not know women?s views or if membrane sweeping is cost-effective compared to other methods of induction. This study will assess the feasibility of performing a randomised controlled trial to answer these questions. Our study consists of four work packages (WP): WP1: A pilot randomised trial to assess the feasibility of conducting a definitive trial to evaluate how often and the best time to perform a sweep. This WP will focus on evaluating how the trial processes function. WP2: Health economic analysis to assess the feasibility of conducting a trial-based economic evaluation to examine the cost-effectiveness of membrane sweeping to prevent post-term pregnancy WP3: A qualitative study Women and clinician's views of trial process are vital in informing the feasibility of a definitive trial. This WP will use interviews to explore the acceptability of the trial for women and clinicians, recruitment processes and clinician training on trial processes. WP4: A pilot study within a trial (SWAT) Trials often do not answer their question because they do not recruit enough participants. This WP will examine the feasibility of conducting a definitive SWAT to assess if the point at which women are invited to take part in the trial (i.e. when should women be asked?) affects the number of women participating in the trial.

Award Date
07 December 2018
Award Value
€374,172.50
Principal Investigator
Professor Declan Devane
Host Institution
National University of Ireland, Galway
Scheme
Definitive Interventions and Feasibility Awards