Title: Cervical Ripening at Home or In-Hospital – prospective cohort study and process evaluation (CHOICE Study)
Funder: Chief Scientist Office, Scotland

Abstract: Labour starts on its own in most pregnancies, but sometimes labour needs to be started artificially - called induction of labour. The most common reason for induction of labour is that the baby is late (a week or more after the due date, called prolonged pregnancy). The first part of induction is ‘cervical ripening’, where either a medication or a specifically designed balloon device is used, to soften and open the neck of the womb (cervix), getting it ready for labour. This is followed by a wait before labour begins or further treatments are required._x000D_ The whole process of cervical ripening used to be performed only in hospitals. However, about half of UK maternity units now offer ‘home cervical ripening’ – where women have the treatment that causes cervical ripening in hospital but can go home for some time whilst waiting for the treatment to work. This may reduce the length of time women spend in hospitals, reduce demands on busy maternity services and may be preferred by women. However, risks and benefits of home cervical ripening are not yet fully understood. Home cervical ripening may be riskier for mother and babies, as some rare complications may not be detected when women are at home._x000D_ Our study aims to see if home cervical ripening is as safe as hospital based cervical ripening, acceptable to women and their partners, and cost effective for the NHS. We will use routinely collected data from the electronic health records of women having induction of labour in 30 UK maternity units. Women will be given the chance to opt out of providing data to the study._x000D_ Our main question is: does home cervical ripening increase the chance that a baby will require specialised care in a neonatal unit (compared to in-hospital)? We will look at this in women having induction of labour for prolonged pregnancy. We will also study other things that are important to women (e.g. caesarean delivery) and markers of how well home cervical ripening works (e.g. length of time spent in hospital). _x000D_ In 5 maternity units we will ask women to fill out questionnaires about their experience of induction of labour. We will use this information to work out how acceptable home cervical ripening is to women, and whether there are additional costs or benefits for women themselves. We will interview some women and some partners about their experiences, and some doctors and midwives, to see how they feel about home cervical ripening. _x000D_ Finally, we will compare the side effects and acceptability of the two most commonly used methods of cervical ripening in the UK – the medication version - a hormone tablet inserted into the vagina (dinoprostone pessary) and a device – a specifically designed cervical ripening balloon catheter that is inserted in the cervix. These may have different side effects and they may also be more or less acceptable from the women’s viewpoint. _x000D_ The team performing the study include midwives, doctors, and clinical trial specialists, as well as women who have experienced induction of labour. We will collaborate with a leading provider of electronic maternity record systems (BadgerNet) in the UK. This will help us to collect the detailed information we need in an efficient way, leaving a platform in place for future studies. We could use this to look for rare but serious problems potentially caused by home cervical ripening. The results of this study will conclude if UK NHS hospitals should continue to offer home cervical ripening.

Lay abstract: RESEARCH QUESTION: Is it safe, effective, cost-effective and acceptable to women to carry out home cervical ripening during induction of labour (IOL)?_x000D_ _x000D_ BACKGROUND: Home cervical ripening has potential to reduce hospital stay during IOL and may be more acceptable to women than in-hospital cervical ripening._x000D_ _x000D_ AIMS & OBJECTIVES: To perform an efficient prospective multicentre observational cohort study using real-world data from hospital electronic health records, linked with nested case studies evaluating process and women/partner experiences, and a cost effectiveness analysis. We will compare home vs in-hospital cervical ripening using a non-inferiority design to determine whether home cervical ripening is within an acceptable margin of in-hospital cervical ripening for the safety outcome of neonatal unit (NNU) admission, whether it is more acceptable to women and whether it is cost- effective._x000D_ _x000D_ SETTING: A minimum of 14 Maternity units offering only in-hospital cervical ripening and 12 offering dinoprostone home cervical ripening. We will also collect data from 4 Maternity units offering balloon catheter home cervical ripening to allow initial comparison of these two methods. We will include units with different sizes and settings using the BadgerNet Maternity information system._x000D_ _x000D_ SAMPLE: 8533 women with singleton pregnancies having IOL for postdates (41 weeks or greater) _x000D_ _x000D_ DATA COLLECTION & ANALYSIS: De-identified data on all eligible women having IOL will be extracted from the BadgerNet Maternity system, from existing data fields, supplemented by new bespoke data fields enabled in participating sites. Data will be securely transferred to the NHS Lothian Safe Haven for analysis (unless women opt-out of secondary data use; estimated <1%). Linked NNU admission data will be obtained from the National Neonatal Research Database (NNRD). 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._x000D_ _x000D_ PROCESS EVALUATION: To identify contextual influences on implementation of cervical ripening protocols and outcomes and assess the acceptability and experience of women and other key stakeholders, we will sample 5 sites, within each undertaking: a survey of women’s experience (n=178), interviews with women (n=50-75), partners (n=35-38) and health professionals (n=18-24), (analysed using a thematic framework) and audio record a sample of consultations where IOL is discussed to assess women’s involvement in the decision making processes (analysed using the OPTION scale). _x000D_ _x000D_ COST EFFECTIVENESS ANALYSIS: This will be undertaken from the perspective of the NHS and include a within study cost-effectiveness analysis and a lifetime cost-utility analysis. Resource use data from electronic health records will be combined with unit costs to calculate the within study cost for each strategy. Outcomes will be reported in terms of incremental cost per NNU admission avoided and incremental cost per quality adjusted life year (QALY) gained. A secondary analysis will consider the patient perspective, including costs incurred by women and their families relating to IOL. _x000D_ _x000D_ TIMELINES: 36 months (m) from October 2019; Set up 6m/Recruitment 20m/Outcome data 4m/Analysis 6m_x000D_ _x000D_ ANTICIPATED IMPACT AND DISSEMINATION: The findings of the study will be used to inform national guidelines on the best setting for cervical ripening.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;8.2 HEALTH AND WELFARE ECONOMICS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH