Outpatient Balloon Catheter Vs Inpatient Prostaglandin for Induction of Labour (OBLIGE): a Randomised Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2020 Feb 19

PMID 32066505

Citations 2

Authors

Michelle R Wise

Joy Marriott

Malcolm Battin

John M D Thompson

Michael Stitely

Lynn Sadler

Affiliations

Soon will be listed here.

Abstract

Background: Approximately one in four pregnant women undergo an induction of labour. The purpose of this study is to investigate the clinical effectiveness, safety, and cost-effectiveness for mothers and babies of two methods of cervical ripening - inpatient care for women starting induction with vaginal prostaglandin E2 hormones, or allowing women to go home for 18 to 24 h after starting induction with a single-balloon catheter.

Methods/design: This is a multi-centre randomised controlled trial in New Zealand. Eligible pregnant women, with a live singleton baby in a cephalic presentation who undergo a planned induction of labour at term, will be randomised to outpatient balloon-catheter induction or in-hospital prostaglandin induction. The primary outcome is caesarean section rate. To detect a 24% relative risk reduction in caesarean rate from a baseline of 24.8%, with 80% power and 5% type 1 error, will require 1552 participants in a one to one ratio.

Discussion: If outpatient balloon-catheter induction reduces caesarean section rates, has additional clinical benefits, and is safe, cost-effective, and acceptable to women and clinicians, we anticipate change in induction of labour practice around the world. We think that home-based balloon-catheter induction will be welcomed as part of a patient-centred labour-induction care package for pregnant women.

Trial Registration: Australia New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12616000739415. Registered on 6 June 2016.

Citing Articles

Outpatient Induction of Labor - Are Balloon Catheters an Appropriate Method?.

Rath W, Stelzl P, Kehl S Geburtshilfe Frauenheilkd. 2021; 81(1):70-80.

PMID: 33487667 PMC: 7815336. DOI: 10.1055/a-1308-2341.

Home versus inpatient induction of labour for improving birth outcomes.

Alfirevic Z, Gyte G, Pileggi V, Plachcinski R, Osoti A, Finucane E Cochrane Database Syst Rev. 2020; 8:CD007372.

PMID: 32852803 PMC: 8094591. DOI: 10.1002/14651858.CD007372.pub4.

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