Clinical trial NCT04307199: Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study
Official title: Feasibility Study Protocol of a Pragmatic, Randomised Controlled Pilot Trial: Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2020-03-13
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Recruitment
timeFrame: Duration of the recruitment process (approximately 8 months )
measure: Retention
timeFrame: At month 15 approximately
measure: Adherence with the trial interventions.
timeFrame: At month 15 approximately
measure: Evaluation of the randomisation process.
timeFrame: At month 15 approximately
measure: Evaluation of attrition rates
timeFrame: At month 15 approximately
measure: Evaluation of the types of attrition
timeFrame: At month 21 approximately
measure: Evaluation of the data collection process through study specific checklists
timeFrame: At month 21 approximately
measure: Estimate the main effect of individual intervention components and their interactions
timeFrame: At month 21 approximately
measure: Evaluation of the data analysis process
timeFrame: At month 21 approximately
measure: Evaluation of the EQ5D
timeFrame: At month 21 approximately
measure: Feasibility of cost analyses process through analysis of study specific documentation.
timeFrame: At month 21 approximately
measure: Feasibility of the cost effectiveness analyses
timeFrame: At month 21 approximately
Secondary outcomes:
measure: Number of participants achieving a spontaneous onset of labour
timeFrame: From time of randomisation to commencement of spontaneous onset of labour or formal induction of labour or caesarean section (up to 5 weeks)
measure: Number of participants who underwent an induction of labour
timeFrame: From time of randomisation to commencement of formal induction of labour (up to 5 weeks).
measure: Number of participants achieving a spontaneous vaginal birth
timeFrame: From time of randomisation to birth of baby (up to 5 weeks)
measure: Instrumental birth
timeFrame: From time of randomisation to birth of baby (up to 5 weeks)
measure: Caesarean Section
timeFrame: From time of randomisation to birth of baby (up to 5 weeks)
measure: Post-Partum Haemorrhage ≥ 500mls
timeFrame: From time of birth to 24 hours after the birth of baby.
measure: Antepartum haemorrhage requiring hospital admission
timeFrame: From 24+0 weeks of pregnancy to birth of baby (up to 18 weeks)
measure: Uterine hyperstimulation with/without fetal heart rate (FHR) changes
timeFrame: From time of randomisation to birth of baby (up to 5 weeks)
measure: Serious maternal death or morbidity
timeFrame: From time of randomisation to six weeks postnatal (up to 11 weeks).
measure: Epidural analgesia
timeFrame: From time of randomisation to birth of baby (up to 5 weeks)
measure: Augmentation of labour
timeFrame: From commencement of established labour to birth of baby (up to 2 days)
measure: Pyrexia in labour
timeFrame: From commencement of established labour to birth of baby (up to 2 days)
measure: Uterine rupture
timeFrame: From time of randomisation to birth of baby (up to 5 weeks)
measure: EQ5D-5L
timeFrame: From time of randomisation to six weeks postnatal (up to 11 weeks)
measure: Serious neonatal morbidity
timeFrame: From time of birth of baby to six weeks postnatal.
measure: Apgar score < 7 at five minutes.
timeFrame: From birth of baby to five minutes of life.
measure: Cord PH < 7.20
timeFrame: From birth of infant to collection of cord bloods after delivery of the placenta (an average of 15 minutes)
measure: Neonatal encephalopathy
timeFrame: From time of birth to six weeks postnatal.
measure: Perinatal death
timeFrame: From time of randomisation to seven completed days after birth of baby (up to 6 weeks)
measure: Admission to neonatal intensive care unit or equivalent
timeFrame: From time of birth to six weeks postnatal.
measure: Length of time from membrane sweep to birth of baby.
timeFrame: From time of membrane sweep to birth of baby (up to 4 weeks)
measure: Length of time from formal induction of labour to birth of baby.
timeFrame: From time of formal induction of labour to birth of baby (up to 2 weeks)
measure: Overall length of maternal hospital stay
timeFrame: From time of randomisation to six weeks postnatal (up to 11 weeks).
measure: Length of infant stay in neonatal intensive care unit or equivalent
timeFrame: From time of birth to six weeks postnatal.
Other outcomes:
Locations:
Study officials:
affiliation: National University of Ireland, Galway
name: Declan Devane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.