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

Pregnancy Related Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Induced; Birth
• Pregnancy Related
• Pregnancy, Prolonged

• NCT number: NCT04307199
• Study type: Interventional
• Source: National University of Ireland, Galway, Ireland
• Contact: Elaine M Finucane, BSc
• Phone: +353 91 495938
• Email: Elainemay.finucane@nuigalway.ie
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2020
• Completion date: December 30, 2021