Authors' objectives: Around one in three pregnant women undergoes induction of labour in the United Kingdom, usually preceded by in-hospital cervical ripening to soften and open the cervix. This study set out to determine whether cervical ripening at home is within an acceptable safety margin of cervical ripening in hospital, is effective, acceptable and cost-effective from both National Health Service and service user perspectives. Around one in three pregnant women in the UK undergo induction of labour (IOL). The first step often involves cervical ripening (opening and shortening the cervix). Cervical ripening may be undertaken using either balloon catheters or administration of prostaglandin. Cervical ripening at home may reduce hospital stay during IOL and may be more acceptable to women than in-hospital cervical ripening. It is unclear whether it may increase risks to the unborn baby due to less monitoring of their well-being during the IOL process and whether it is acceptable to women and partners. It is also unclear whether home cervical ripening is cost-effective. To assess whether it is safe, effective, cost-effective and acceptable to service users and providers to carry out home cervical ripening during IOL, the research questions asked were: Is home cervical ripening within an acceptable margin of in-hospital cervical ripening for safety, cost and acceptability outcomes? Is a strategy of home cervical ripening using a balloon as safe as in-hospital cervical ripening using prostaglandin for the primary outcome of neonatal unit (NINU) admission within 48 hours of birth for 48 hours or more? Is home cervical ripening as acceptable to service-users and health professionals as in-hospital cervical ripening? Are NHS and service user costs of home cervical ripening using a balloon comparable to costs of in-hospital cervical ripening using prostaglandin?

Authors' results and conclusions: CHOICE cohort: A total of 515 women underwent balloon cervical ripening at home and 4332 underwent in-hospital cervical ripening using prostaglandin in hospitals that did not offer home cervical ripening. Neonatal unit admission within 48 hours of birth for 48 hours or more following home cervical ripening with balloon was not increased compared with in-hospital cervical ripening with prostaglandin. However, there was substantial uncertainty with the adjusted analysis consistent with a 74% decrease in the risk through to an 81% increase. Home cervical ripening using balloon catheter may be as safe for babies as using prostaglandins in hospital in low and moderate-risk groups, but there is substantial uncertainty. Home cervical ripening with balloon is likely to be cost saving. Impacts on workload, service user and staff experiences were complex. Observational cohort study The unanticipated context of the CHOICE study was an NHS under pressure to manage high IOL rates (range 31–49%) and long delays throughout the IOL process during the COVID-19 pandemic. Home cervical ripening using balloon was performed in women for a wide array of indications (low to moderate risk groups) and from 37 weeks of gestation. The main analysis population consisted of 17,350 women with singleton pregnancies having IOL at 37 weeks or later, of whom 515 underwent home cervical ripening using balloon, 4332 underwent in-hospital cervical ripening with prostaglandin in hospitals that only offered in-hospital cervical ripening, and 7397 women underwent in-hospital cervical ripening with prostaglandin in a hospital that also offered home cervical ripening. Compared with in-hospital cervical ripening with prostaglandin, the rate of NNU admission within 48 hours of birth for 48 hours or more following home cervical ripening with balloon was not increased. The event rate for this primary outcome was expected to be 6% for the in-hospital group. The rate was much lower than expected in both arms (3.1% after home cervical ripening vs. 4.8% after in-hospital cervical ripening) and there was no statistically significant difference between groups before or after adjusting for potential confounding variables. However, the odds ratio of 0.75 has a wide 95% confidence interval (CI) of 0.35 to 1.64 (0.81; 95% CI 0.36 to 1.81 in the adjusted analysis) signalling substantial uncertainty in this finding. The CHOICE study provided multiple perspectives on the difference between home cervical ripening with balloon and in-hospital cervical ripening with prostaglandin during IOL, within a context of high IOL rates and multiple delays in the process. Home cervical ripening with balloon appears both safe and cost-effective when compared with in-hospital cervical ripening with prostaglandin for a range of indications, although safety conclusions are uncertain. Acceptance of home cervical ripening depends upon high-quality informed decision-making and consistent support for women throughout the IOL process, a reality that was often lacking in the study participants’ experience. Future research should focus on: Further exploration and implementation of system features that lead to positive experiences of home cervical ripening. Measuring rare but important safety outcomes of home cervical ripening. Practice implications of the CHOICE findings are that units should consider the practicalities of offering genuine choice around setting for IOL and ensure adequate staffing and support for women throughout their IOL experience regardless of setting for cervical ripening. Unless women feel supported to choose between home and in-hospital settings, and they have sufficient information to allow realistic expectations of the IOL process, women will not have positive birth experiences.

Authors' methods: The CHOICE study comprised a prospective multicentre observational cohort study using routinely collected data (CHOICE cohort), a process evaluation comprising a survey and nested case studies (qCHOICE) and a cost-effectiveness analysis. The CHOICE cohort set out to compare outcomes of cervical ripening using dinoprostone (a prostaglandin) at home with in-hospital cervical ripening from 39 weeks of gestation. Electronic maternity record data were collected from 26 maternity units. Following pilot analysis, the primary comparison was changed to ensure feasibility and to reflect current practice, comparing home cervical ripening using a balloon catheter with in-hospital cervical ripening using any prostaglandin from 37 weeks of gestation. Analysis involved multiple logistic regression for the primary outcome and descriptive statistics for all other outcomes. The qCHOICE study reported descriptive statistics of quantitative survey data and thematic analysis of focus group and interview data. The economic analysis involved a decision-analytic model from a National Health Service and Personal Social Services perspective, populated with CHOICE cohort and published data. Secondary analysis explored the patient perspective utilising cost estimates from qCHOICE data. Twenty-six United Kingdom maternity units. Women with singleton pregnancies at or beyond 37 weeks of gestation having induction with details of cervical ripening method and location recorded. CHOICE cohort Neonatal unit admission within 48 hours of birth for 48 hours or more. Electronic maternity records from 26 maternity units; survey and interviews with service users/maternity staff; focus groups with maternity staff; published literature on economic aspects. Circumstances relating to the COVID-19 pandemic limited the number of participating maternity units and the duration for which units participated. Low numbers of women having at-home cervical ripening limited the power to detect differences in safety, effectiveness, cost and acceptability between study groups. This project incorporated a prospective multicentre observational cohort study using real-world data from hospital electronic health records, a survey of service users and nested case studies involving interviews and focus groups, evaluating process and service user and provider experiences, and a health economic analysis. The original design was a comparison of home versus in-hospital cervical ripening using a non-inferiority design to determine whether home cervical ripening is within an acceptable margin (+ 4%) of in-hospital cervical ripening for the safety outcome of NNU admission, whether it is more acceptable to women and whether it is cost-effective. As insufficient home cervical ripening cases were identified at the pilot analysis stage, the statistical analysis was modified to a simple logistic regression on the primary outcome (NNU admission within 48 hours for 48 hours or more), unadjusted and adjusted by potential confounders. This was done because the limited sample size of the primary exposure variable (home vs. hospital) did not have enough power to answer the non-inferiority question as proposed. This had a knock-on effect on the other aspects of the project as well. Observational cohort A total of 26 maternity units in the UK contributed data to the observational cohort study, of whom 8 offered balloon home cervical ripening and 18 offered only in-hospital cervical ripening using prostaglandin. The sample included geographically and socially diverse populations. All units used the BadgerNet Maternity Notes (System C, Stratford-upon-Avon, UK) information system to record routine maternity care information. Deidentified data on all eligible women having IOL was extracted from the BadgerNet system using existing data fields. Data were securely transferred to the University of Edinburgh. Data were analysed using SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA). We used mixed-effects logistic regression for the comparison of NNU admission within 48 hours to control for treatment indication bias, with hospital/trust as a random effect. Further outcomes were reported descriptively as medians and interquartile ranges, proportions and percentages. Electronic patient records from 26 study sites (extracted via the BadgerNet maternity records data system): observational cohort study; economic analysis. Qualitative interviews and focus groups: process evaluation. Postnatal survey: process evaluation; economic analysis. Published literature: economic analysis.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR127569

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/LPYT7894

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/LPYT7894

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk