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

Stock, S. J., Bhide, A., Richardson, H., Black, M., Yuill, C. ORCID: 0000-0002-3918-5917, Harkness, M., Reid, M., Wee, F., Cheyne, H., McCourt, C. ORCID: 0000-0003-4765-5795, Rana, D., Boyd, K., Sanders, J., Heera, N., Huddleston, J., Denison, F., Pasupathy, D., Modi, N., Smith, G. and Norrie, J. (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

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.

Publication Type: Article
Additional Information: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made.
Subjects: R Medicine > RG Gynecology and obstetrics
Departments: School of Health Sciences > Midwifery & Radiography
Date available in CRO: 12 May 2021 13:12
Date deposited: 12 May 2021
Date of acceptance: 6 April 2021
Date of first online publication: 4 May 2021
URI: https://openaccess.city.ac.uk/id/eprint/26134
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