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

Abstract

IntroductionThe 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 analysisWe 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 disseminationCHOICE 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 numberISRCTN32652461.

Safety, effectiveness, womenʼs experience, and economic costs of outpatient induction in women with uncomplicated pregnancies: A systematic review and meta‐analyses

“…The systematic literature searches identified 10 RCTs, 6,7,9,[30][31][32][33][34][35][36] five non-RCTs, 14,[37][38][39][40] two qualitative interview studies, 41,42 and three cost analyses [43][44][45] that fulfilled the inclusion criteria (PICO). Table S1 presents the characteristics of the included studies and Table S2 lists the excluded studies with reasons for exclusion.…”

Clinicians’ perspectives and experiences of providing cervical ripening at home or in-hospital in the United Kingdom

“…This research was undertaken as part of the CHOICE Study, a prospective cohort study and process evaluation investigating cervical ripening at home or in-hospital [7]. The process evaluation .…”

Experience of induction of labour: a cross-sectional postnatal survey of women at UK maternity units

“…This study was undertaken as part of the CHOICE Study, a prospective cohort study and process evaluation 8 commissioned by the National Institute for Health and Care Research (NIHR) to examine the safety, efficacy and acceptability of home CR and CR in hospital. The process evaluation (qCHOICE) included a postnatal questionnaire-based survey (reported here).…”

“…Traditionally the whole process of IOL has been undertaken in hospital, however, some maternity units now offer home CR: women attend hospital for initial assessment and administration of CR agent and then return home for a period before labour starts or reassessment in hospital. Some evidence indicates that home cervical ripening could reduce duration of hospital stay during IOL and improve women’s experience, however, its safety and acceptability has not been fully evaluated (8).…”