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 |