Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study

Feasibility Study Protocol of a Pragmatic, Randomised Controlled Pilot Trial: Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study

Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design.

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/Design

Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton fetus ≥ 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 verses weekly sweep

The proposed feasibility study consists of four work packages i.e., (1) a multicentre, pilot randomised trial, 2) a health economic analysis and 3) a qualitative study (4) a study within the host trial (a SWAT).

Inclusion Criteria:

• Pregnant women carrying a live singleton fetus ≥ 38 weeks completed gestation.
• (Gestational age will be calculated from the first day of the last menstrual period and an
• ultrasound examination carried out in the 2nd trimester)
• Longitudinal lie
• Cephalic presentation
• Intact amniotic
• ≥ 18 years of age on enrollment

Exclusion Criteria:

• Not able to communicate in english
• contraindications to a vaginal examination
• contraindications to a vaginal birth