Abstract
BackgroundPost-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews).Methods/designMulticentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton foetus ≥ 38 weeks gestation; cephalic presentation; longitudinal lie; intact membranes; English speaking and ≥ 18 years of age will be randomised in a 2:1 ratio to membrane sweep versus no membrane sweep. Women allocated randomly to a sweep will then be randomised further (factorial component) to early (from 39 weeks) versus late (from 40 weeks) sweep commencement and a single versus weekly sweep. The proposed feasibility study consists of four work packages, i.e. (1) a multicentre, pilot randomised trial; (2) a health economic analysis; (3) a qualitative study; and (4) a study within the host trial (a SWAT). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. Focus groups will be held with women and clinicians to explore the acceptability and feasibility of the proposed intervention, study procedures and perceived barriers and enablers to recruitment.DiscussionThe primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. Results will inform whether and how the design of the definitive trial as originally envisaged should be delivered or adapted.Trial registrationClinicalTrials.gov NCT04307199. Registered on 12 March 2020
Highlights
Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate
The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness of membrane sweeping to prevent post-term pregnancy
It allows us to evaluate the feasibility of a future trial to answer the primary question ‘is membrane sweeping effective in preventing post-term pregnancy?’ and address the effectiveness of different timings and frequency of membrane sweeping
Summary
Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. Labour and childbirth are physiological processes, and for the majority of women, the onset of labour is spontaneous. Current World Health Organization guidelines note that induction of labour, as with any intervention, carries risks and advise that induction of labour is not recommended for women with uncomplicated pregnancies less than 41 weeks gestation [2]. Medical indications for induction of labour include preterm premature rupture of membranes (PPROM), intrauterine growth restriction, hypertensive disorders of pregnancy, intrauterine foetal death and post-term pregnancies [6]. Post-term pregnancy is the most common [7, 8]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
