#Membrane sweep at 38 weeks an two days trial

Results will inform whether and how the design of the definitive trial as originally envisaged should be delivered or adapted. 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. 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. Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. (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). The proposed feasibility study consists of four work packages, i.e. 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.

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.

Multicentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews). However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate.

Membrane sweep at 38 weeks an two days