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

National University of Ireland, Galway, Ireland

Status: Unknown

Conditions: Induced; Birth; Pregnancy, Prolonged; Pregnancy Related

Treatments: Procedure: Amniotic membrane sweep

Study type: Interventional

Funder types: Other

Identifiers

NCT04307199

NUIreland - MILO

Details and patient eligibility

About

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

Full 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).

Enrollment: 132 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

132 participants in 5 patient groups

Group A

Experimental group

Description:

Membrane sweep @ 39 weeks' gestation only

Treatment:

Procedure: Amniotic membrane sweep

Group B

Experimental group

Description:

Membrane sweep @ 40 weeks' gestation only

Treatment:

Procedure: Amniotic membrane sweep

Group C

Experimental group

Description:

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

Treatment:

Procedure: Amniotic membrane sweep

Group D

Experimental group

Description:

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

Treatment:

Procedure: Amniotic membrane sweep

Control Group

No Intervention group

Description:

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).