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

Elaine M. Finucane; Linda Biesty; Deirdre Murphy; Amanda Cotter; Eleanor Molloy; Martin O’Donnell; Shaun Treweek; Paddy Gillespie; Marian Campbell; John J. Morrison; Alberto Alvarez-Iglesias; Gill Gyte; Declan Devane

doi:10.1186/s13063-021-05043-9

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

Elaine M. Finucane^* (Corresponding Author), Linda Biesty, Deirdre Murphy, Amanda Cotter, Eleanor Molloy, Martin O’Donnell, Shaun Treweek, Paddy Gillespie, Marian Campbell, John J. Morrison, Alberto Alvarez-Iglesias, Gill Gyte, Declan Devane

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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. Trial registration: ClinicalTrials.gov NCT04307199. Registered on 12 March 2020

Original language	English
Article number	113
Number of pages	15
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05043-9
Publication status	Published - 2 Feb 2021

Bibliographical note

Funding
The Health Research Board Ireland has funded the MILO Study through the Definitive Interventions and Feasibility Awards (DIFA) 2018. Health Research Board, Grattan House 67-72 Lower Mount Street, Dublin 2, D02 H638 The funder does not have a role in the study design, data collection, analysis and interpretation of the data or in writing the manuscript.

Keywords

Feasibility
Pilot tria
SWAT
Induction of labour
Membrane sweep
Post-term
Pilot trial

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Finucane, E. M., Biesty, L., Murphy, D., Cotter, A., Molloy, E., O’Donnell, M., Treweek, S., Gillespie, P., Campbell, M., Morrison, J. J., Alvarez-Iglesias, A., Gyte, G., & Devane, D. (2021). Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy—the MILO Study. Trials, 22(1), Article 113. https://doi.org/10.1186/s13063-021-05043-9

Finucane, EM, Biesty, L, Murphy, D, Cotter, A, Molloy, E, O’Donnell, M, Treweek, S, Gillespie, P, Campbell, M, Morrison, JJ, Alvarez-Iglesias, A, Gyte, G & Devane, D 2021, 'Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy—the MILO Study', Trials, vol. 22, no. 1, 113. https://doi.org/10.1186/s13063-021-05043-9

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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. Trial registration: ClinicalTrials.gov NCT04307199. Registered on 12 March 2020",

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note = "Funding The Health Research Board Ireland has funded the MILO Study through the Definitive Interventions and Feasibility Awards (DIFA) 2018. Health Research Board, Grattan House 67-72 Lower Mount Street, Dublin 2, D02 H638 The funder does not have a role in the study design, data collection, analysis and interpretation of the data or in writing the manuscript.",

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T2 - membrane sweeping to prevent post-term pregnancy—the MILO Study

AU - Finucane, Elaine M.

AU - Biesty, Linda

AU - Murphy, Deirdre

AU - Cotter, Amanda

AU - Molloy, Eleanor

AU - O’Donnell, Martin

AU - Treweek, Shaun

AU - Gillespie, Paddy

AU - Campbell, Marian

AU - Morrison, John J.

AU - Alvarez-Iglesias, Alberto

AU - Gyte, Gill

AU - Devane, Declan

N1 - Funding The Health Research Board Ireland has funded the MILO Study through the Definitive Interventions and Feasibility Awards (DIFA) 2018. Health Research Board, Grattan House 67-72 Lower Mount Street, Dublin 2, D02 H638 The funder does not have a role in the study design, data collection, analysis and interpretation of the data or in writing the manuscript.

PY - 2021/2/2

Y1 - 2021/2/2

N2 - 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. Trial registration: ClinicalTrials.gov NCT04307199. Registered on 12 March 2020

AB - 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. Trial registration: ClinicalTrials.gov NCT04307199. Registered on 12 March 2020

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

Abstract

Bibliographical note

Keywords

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