Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial.

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dc.contributor.author Wise, Michelle en
dc.contributor.author Marriott, Joy en
dc.contributor.author Battin, Malcolm en
dc.contributor.author Thompson, John en
dc.contributor.author Stitely, Michael en
dc.contributor.author Sadler, Lynn en
dc.date.accessioned 2020-06-04T21:24:15Z en
dc.date.issued 2020-02-17 en
dc.identifier.citation Trials 21(1):190 17 Feb 2020 en
dc.identifier.issn 1745-6215 en
dc.identifier.uri http://hdl.handle.net/2292/51348 en
dc.description.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. en
dc.format.medium Electronic en
dc.language eng en
dc.relation.ispartofseries Trials en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
dc.rights.uri https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm en
dc.rights.uri https://creativecommons.org/licenses/by/4.0/ en
dc.title Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial. en
dc.type Journal Article en
dc.identifier.doi 10.1186/s13063-020-4061-5 en
pubs.issue 1 en
pubs.begin-page 190 en
pubs.volume 21 en
dc.rights.holder Copyright: The authors en
pubs.publication-status Published en
dc.rights.accessrights http://purl.org/eprint/accessRights/OpenAccess en
pubs.subtype research-article en
pubs.subtype Journal Article en
pubs.elements-id 795743 en
pubs.org-id Medical and Health Sciences en
pubs.org-id School of Medicine en
pubs.org-id Obstetrics and Gynaecology en
pubs.org-id Paediatrics Child & Youth Hlth en
dc.identifier.eissn 1745-6215 en
pubs.record-created-at-source-date 2020-02-19 en
pubs.dimensions-id 32066505 en

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