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. 2024 Dec;28(81):1–142. doi: 10.3310/LPYT7894

Cervical ripening at home or in hospital during induction of labour: the CHOICE prospective cohort study, process evaluation and economic analysis.

Mairead Black, Cassandra Yuill, Mairi Harkness, Sayem Ahmed, Linda Williams, Kathleen A Boyd, Maggie Reid, Amar Bhide, Neelam Heera, Jane Huddleston, Neena Modi, John Norrie, Dharmintra Pasupathy, Julia Sanders, Gordon C S Smith, Rosemary Townsend, Helen Cheyne, Christine McCourt, Sarah Stock
PMCID: PMC11683663  PMID: 39707888

Abstract

BACKGROUND

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.

OBJECTIVES

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.

DESIGN

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.

SETTING

Twenty-six United Kingdom maternity units.

PARTICIPANTS

Women with singleton pregnancies at or beyond 37 weeks of gestation having induction with details of cervical ripening method and location recorded.

MAIN OUTCOME MEASURES

Neonatal unit admission within 48 hours of birth for 48 hours or more.

QCHOICE

Maternal and staff experience of cervical ripening.

ECONOMIC ANALYSIS

Incremental cost per neonatal unit admission within 48 hours of birth avoided.

DATA SOURCES

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.

RESULTS

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.

QCHOICE

Important aspects of service users' experience of home cervical ripening were quality of information provided, support and perception of genuine choice.

ECONOMIC ANALYSIS

Home cervical ripening with balloon led to cost savings of £993 (-£1198, -£783) per woman and can be considered the dominant strategy.

LIMITATIONS

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.

CONCLUSIONS

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.

FUTURE WORK

Future research should focus on optimising experience and logistics of home cervical ripening within busy maternity services.

STUDY REGISTRATION

Current Controlled Trials ISRCTN32652461.

FUNDING

This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127569) and is published in full in Health Technology Assessment; Vol. 28, No. 81. See the NIHR Funding and Awards website for further award information.

Plain language summary

Labour is often started artificially. This is called induction of labour. Induction of labour is usually planned when it is safer to end the pregnancy. The first stage of induction of labour – ‘cervical ripening’ – means using medication or a balloon to open the neck of the womb. Years ago, cervical ripening only happened in hospitals, but now many women are offered ‘home cervical ripening’. This means that induction of labour starts in hospital then women go home while the treatment starts working. This could mean that women spend less time in hospital. They may prefer to be at home. However, home cervical ripening may be less safe because problems may not be noticed as quickly. We looked at whether home cervical ripening is safe, acceptable to women and their partners, and good value for money. We used information about women and babies that is usually stored in electronic maternity notes. We studied women who had induction of labour in 26 United Kingdom maternity hospitals. Women were told about the study and could choose not to be included. Our main question was ‘does home cervical ripening increase the chance that a baby needs care in a neonatal unit, compared with cervical ripening in hospital?’ We surveyed women about their experience of induction of labour and any financial costs to them. We interviewed women, partners, doctors and midwives to hear what they thought about home cervical ripening. Fewer women than expected had home cervical ripening. We could not be certain that home cervical ripening with a balloon is as safe for babies as cervical ripening in hospital using medication. Home cervical ripening cost almost £1000 less per woman than in-hospital cervical ripening. Home cervical ripening was acceptable to women when they felt well looked after, when maternity staff communicated well with them, and when they felt they had a choice about going home.

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