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

NCT04307199 | Unknown DMC

• 1 other identifier: NUIreland - MILO
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pregnancy, Prolonged; Induced; Birth; Pregnancy Related

Keywords

membrane sweep; feasibility study; randomised trial; pilot study; SWAT; pregnancy; induction of labour; post dates; prolonged pregnancy

Outcome Measures

Primary Outcomes (12)

• Recruitment

  Evaluation of the number and percentage of eligible women who are recruited and randomised to the study. Assessed by study-specific checklists.

  Duration of the recruitment process (approximately 8 months )

• Retention

  Evaluation of the number and percentage of eligible women who are randomised, take part in and adhere to the study protocols. Data will be extracted from routinely collected data.

  At month 15 approximately

• Adherence with the trial interventions.

  Evaluation of adherence with the trial interventions, and reasons for non-compliance assessed by study-specific checklists. Data will be extracted from routinely collected data and focus group interviews with clinicians and participants at six weeks post intervention.

  At month 15 approximately

• Evaluation of the randomisation process.

  Evaluation of effective allocation of participants to the intervention/control group assessed by study-specific checklists and evaluation of the randomisation protocol throughout the randomisation period.

  At month 15 approximately

• Evaluation of attrition rates

  Evaluation of attrition rates assessed by study-specific checklists. Data will be extracted from routinely collected data.

  At month 15 approximately

• Evaluation of the types of attrition

  Evaluation of the types of attrition assessed by case report forms. Data will be extracted from routinely collected data.

  At month 21 approximately

• Evaluation of the data collection process through study specific checklists

  Evaluated, statistically and narratively, by assessing the completeness of outcome measurements at baseline and postnatal (6 weeks) through study specific checklists. Researchers will manually examine the data collected. They will assess the proportion of complete data collection forms, the quality of data collected and the applicability of this data in facilitating pilot trial outcomes.

  At month 21 approximately

• Estimate the main effect of individual intervention components and their interactions

  Estimates (with measures of uncertainty) of the main effect of individual intervention components and any interaction effect between the main effects of the embedded factorial design will be assessed and reported using regression analysis.

  At month 21 approximately

• Evaluation of the data analysis process

  As this is a feasibility study formal hypothesis testing will not be undertaken. Researchers will manually examine the data collected. Evaluation of the data analysis process will be undertaken through the assessment of gaps and limitations to the analysis process measured by study-specific checklist. Findings will be reported through descriptive statistics and graphical summaries.

  At month 21 approximately

• Evaluation of the EQ5D

  Assessment of the mechanism of, timing of and delivery of the EQ5D through study specific checklists.

  At month 21 approximately

• Feasibility of cost analyses process through analysis of study specific documentation.

  Assessment of data collection tools to undertake cost effectiveness analysis through study specific documentation. Researchers will manually examine data to assess the mechanism of, timing of and delivery of the cost analysis tools.

  At month 21 approximately

• Feasibility of the cost effectiveness analyses

  Assessment of the mechanism and utilisation of the incremental cost-effectiveness ratio (ICER), through study specific checklists.

  At month 21 approximately

Secondary Outcomes (24)

• Number of participants achieving a spontaneous onset of labour

  From time of randomisation to commencement of spontaneous onset of labour or formal induction of labour or caesarean section (up to 5 weeks)

• Number of participants who underwent an induction of labour

  From time of randomisation to commencement of formal induction of labour (up to 5 weeks).

• Number of participants achieving a spontaneous vaginal birth

  From time of randomisation to birth of baby (up to 5 weeks)

• Instrumental birth

  From time of randomisation to birth of baby (up to 5 weeks)

• Caesarean Section

  From time of randomisation to birth of baby (up to 5 weeks)

Study Arms (5)

Group A

EXPERIMENTAL

Membrane sweep @ 39 weeks' gestation only

Procedure: Amniotic membrane sweep

Group B

EXPERIMENTAL

Membrane sweep @ 40 weeks' gestation only

Procedure: Amniotic membrane sweep

Group C

EXPERIMENTAL

Membrane sweep @ 39, 40 and 41 weeks' gestation or until onset of labour

Procedure: Amniotic membrane sweep

Group D

EXPERIMENTAL

Membrane sweep @ 40 and 41 weeks' gestation or until onset of labour

Procedure: Amniotic membrane sweep

Control Group

NO INTERVENTION

Women in the control arm will not receive a membrane sweep and will receive usual care (as defined by local hospital protocols and vaginal examination to determine Bishop score only).

Interventions

Amniotic membrane sweep PROCEDURE

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.

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women carrying a live singleton fetus ≥ 38 weeks completed gestation.
• (Gestational age will be calculated from the first day of the last menstrual period and an
• ultrasound examination carried out in the 2nd trimester)
• Longitudinal lie
• Cephalic presentation
• Intact amniotic
• ≥ 18 years of age on enrollment

You may not qualify if:

• Not able to communicate in english
• contraindications to a vaginal examination
• contraindications to a vaginal birth

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Health Research Board, Ireland: collaborator

Related Publications (1)

• 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. Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy-the MILO Study. Trials. 2021 Feb 2;22(1):113. doi: 10.1186/s13063-021-05043-9.

  PMID: 33531062 DERIVED

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Declan Devane, PhD

  National University of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaine M Finucane, BSc

CONTACT

+353 91 495938; Elainemay.finucane@nuigalway.ie

Declan Devane, PhD

CONTACT

+353 91 495 828; declan.devane@nuigalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinicians performing a membrane sweep cannot be blinded and it is not feasible to genuinely blind membrane sweeping for women. Therefore, neither clinicians administering the intervention nor women will be blinded to group assignment. Data will be reviewed by two assessors blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, HRB-Trials Methodology Research Network

Model Details: Women will initially be randomised in a 2:1 ratio to: • Membrane sweep (2) versus no membrane sweep (1). Those allocated to the intervention group will then be further randomised in a factorial fashion to A, B, C or D: A. Membrane sweep @ 39 weeks' gestation only B. Membrane sweep @ 40 weeks' gestation only C. Membrane sweep @ 39, 40 and 41 weeks' gestation or until onset of labour D. Membrane sweep @ 40 and 41 weeks' gestation or until onset of labour

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: March 13, 2020
• Study Start: July 30, 2020
• Primary Completion: March 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share