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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2021-12-30

Brief Summary

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

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Detailed Description

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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).

Conditions

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Pregnancy, Prolonged Induced; Birth Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Group A

Membrane sweep @ 39 weeks' gestation only

Group Type EXPERIMENTAL

Amniotic membrane sweep

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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