NCT04307199

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: National University of Ireland, Galway, Ireland · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Pregnancy, Prolonged
• Induced; Birth
• Pregnancy Related

Interventions

Type	Name	Description
PROCEDURE	Amniotic membrane sweep	Amniotic membrane sweeping is defined as the manual detachment of the inferior pole of the amniotic membranes from the lower uterine segment. This is performed with consent by a clinician digitally through a circular motion during a vaginal examination. If the cervical os is closed massage of the cervix will be accepted.

Timeline

• Start date: 2020-07-30
• Primary completion: 2021-03-30
• Completion: 2021-12-30
• First posted: 2020-03-13
• Last updated: 2020-05-14