Development of a core outcome set for trials on induction of labour (COSIOL): an international multi-stakeholder Delphi study
File(s)COSIOL Final 14 Jun 18.docx (75.38 KB)
Accepted version
Author(s)
Type
Journal Article
Abstract
OBJECTIVE: To develop a set of core outcomes to be minimally reported in trials on induction of labour. DESIGN: Two-round Delphi survey and consensus meeting. POPULATION: Four Stakeholder groups: midwives, obstetricians, neonatologists, and women's representatives. METHODS: Protocol registered with COMET (registration number: 695). Stakeholders rated reported outcomes for importance (1-limited to 9-critical). The median rating of each outcome was calculated. The consensus criteria to include outcomes were: ≥ 70% participants rated outcomes as critical and <15% rated outcomes as limited importance. Outcomes that did not achieve consensus were taken to round two, and if still no consensus, to the final consensus meeting. MAIN OUTCOME MEASURES: Outcomes in trials of induction of labour. RESULTS: Of the 159 invited participants, 54% (86/159) completed the first round, and 83% completed the second round (71/86). The core outcome set included 28 core outcomes in four domains: Short-term maternal outcomes (n=18) - cardio-respiratory arrest, damage to internal organs, death, haemorrhage, hysterectomy, infection, intensive care admission, length of hospital stay, mode of delivery, need for more than one induction agent, oxytocin augmentation, postnatal depression, pulmonary embolus, satisfaction with care, stroke, time from induction to delivery, uterine hyperstimulation, uterine scar dehiscence/rupture; Short-term offspring outcomes (n=8) - admission to the neonatal unit, birth trauma, death, hypoxic ischaemic encephalopathy/need for therapeutic hypothermia, meconium aspiration syndrome, need for respiratory support, infection, seizures; Long-term maternal outcomes (n=1) - operative pelvic floor repair; Long-term offspring outcomes (n=1) - disability including neurodevelopmental delay. CONCLUSION: Trials on induction of labour should include this core outcome set to standardise reporting. This article is protected by copyright. All rights reserved.
Date Issued
2018-12
Date Acceptance
2018-06-19
Citation
BJOG: An International Journal of Obstetrics and Gynaecology, 2018, 125 (13), pp.1673-1680
ISSN
1470-0328
Publisher
Wiley
Start Page
1673
End Page
1680
Journal / Book Title
BJOG: An International Journal of Obstetrics and Gynaecology
Volume
125
Issue
13
Copyright Statement
© 2018. This is the pre-peer reviewed version of the following article: Dos Santos, F, Drymiotou, S, Antequera Martin, A, Mol, BW, Gale, C, Devane, D, Hooft, J, Johnson, MJ, Hogg, M, Thangaratinam, S. Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study. BJOG 2018; 125: 1673– 1680, which has been published in final form at https://doi.org/10.1111/1471-0528.15397
Sponsor
Medical Research Council
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/29981523
Grant Number
MR/N008405/1
Subjects
CROWN
Core outcome set
Induction of labour
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2018-07-07