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Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design.
Full 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:
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).
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132 participants in 5 patient groups
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Central trial contact
Elaine M Finucane, BSc; Declan Devane, PhD
Data sourced from clinicaltrials.gov
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