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Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy—the MILO Study

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dc.contributor.author Finucane, Elaine M.
dc.contributor.author Biesty, Linda
dc.contributor.author Murphy, Deirdre
dc.contributor.author Cotter, Amanda
dc.contributor.author Molloy, Eleanor
dc.contributor.author O'Donnell, Martin
dc.contributor.author Treweek, Shaun
dc.contributor.author Gillespie, Paddy
dc.contributor.author Campbell, Marian
dc.contributor.author Morrison, John J
dc.contributor.author Alvarez-Iglesias, Alberto
dc.contributor.author Gyte, Gill
dc.contributor.author Devane, Declan
dc.date.accessioned 2021-02-24T10:02:44Z
dc.date.available 2021-02-24T10:02:44Z
dc.date.issued 2021
dc.identifier.uri http://hdl.handle.net/10344/9812
dc.description peer-reviewed en_US
dc.description.abstract Background: Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. 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 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. 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. The proposed feasibility study consists of four work packages, i.e. (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). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. 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 .Discussion: 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. Results will inform whether and how the design of the definitive trial as originally envisaged should be delivered or adapted. en_US
dc.language.iso eng en_US
dc.publisher BMC en_US
dc.relation.ispartofseries Trials;22, 113
dc.subject Feasibility en_US
dc.subject Pilot trial en_US
dc.subject SWAT en_US
dc.title Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy—the MILO Study en_US
dc.type info:eu-repo/semantics/article en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.identifier.doi 10.1186/s13063-021-05043-9
dc.contributor.sponsor HRB en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US


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