Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study: a protocol

Stock, S. J. et al. (2021) Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study: a protocol. BMJ Open, 11(5), e050452. (doi: 10.1136/bmjopen-2021-050452) (PMID:33947741) (PMCID:33947741)

Abstract

Introduction: The aim of the cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study is to compare home versus in-hospital cervical ripening to determine whether home cervical ripening is safe (for the primary outcome of neonatal unit (NNU) admission), acceptable to women and cost-effective from the perspective of both women and the National Health Service (NHS). Methods and analysis: We will perform a prospective multicentre observational cohort study with an internal pilot phase. We will obtain data from electronic health records from at least 14 maternity units offering only in-hospital cervical ripening and 12 offering dinoprostone home cervical ripening. We will also conduct a cost-effectiveness analysis and a mixed methods study to evaluate processes and women/partner experiences. Our primary sample size is 8533 women with singleton pregnancies undergoing induction of labour (IOL) at 39+0 weeks’ gestation or more. To achieve this and contextualise our findings, we will collect data relating to a cohort of approximately 41 000 women undergoing IOL after 37 weeks. We will use mixed effects logistic regression for the non-inferiority comparison of NNU admission and propensity score matched adjustment to control for treatment indication bias. The economic analysis will be undertaken from the perspective of the NHS and Personal Social Services (PSS) and the pregnant woman. It will include a within-study cost-effectiveness analysis and a lifetime cost–utility analysis to account for any long-term impacts of the cervical ripening strategies. Outcomes will be reported as incremental cost per NNU admission avoided and incremental cost per quality adjusted life year gained. Research ethics approval and dissemination: CHOICE has been funded and approved by the National Institute of Healthcare Research Health Technology and Assessment, and the results will be disseminated via publication in peer-reviewed journals. Trial registration number: ISRCTN32652461.

• Item Type: Articles
• Additional Information: CHOICE is funded by the National Institute of Healthcare Research (NIHR) Health Technology and Assessment (NIHR 127569). SJS is supported by Wellcome Trust (209560/Z/17/Z).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Rana, Miss Dikshyanta and Boyd, Professor Kathleen
• Authors: Stock, S. J., Bhide, A., Richardson, H., Black, M., Yuill, C., Harkness, M., Reid, M., Wee, F., Cheyne, H., McCourt, C., Rana, D., Boyd, K. A., Sanders, J., Heera, N., Huddleston, J., Denison, F., Pasupathy, D., Modi, N., Smith, G., and Norrie, J.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment
• Journal Name: BMJ Open
• Publisher: BMJ Publishing Group
• ISSN: 2044-6055
• ISSN (Online): 2044-6055
• Published Online: 04 May 2021
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in BMJ Open 11(5):e050452
• Publisher Policy: Reproduced under a Creative Commons License