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

Stock, Sarah Jane, Bhide, Amarnath, Richardson, Heather, Black, Mairead, Yuill, Cassandra, Harkness, Mairi, Reid, Maggie, Wee, Fiona, Cheyne, Helen, McCourt, Christine, Rana, Dikshyanta, Boyd, Kathleen Anne, Sanders, Julia, Heera, Neelam, Huddleston, Jane, Denison, Fiona, Pasupathy, Dharmintra, Modi, Neena, Smith, Gordon and Norrie, John 2021. Cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study: a protocol. BMJ Open 11 (5) , e050452. 10.1136/bmjopen-2021-050452

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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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Healthcare Sciences
Additional Information: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license
Publisher: BMJ Publishing Group
ISSN: 2044-6055
Date of First Compliant Deposit: 9 June 2021
Date of Acceptance: 6 April 2021
Last Modified: 10 Jun 2021 09:00
URI: http://orca.cardiff.ac.uk/id/eprint/141822

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