Cervical Ripening at Home or In-Hospital – prospective cohort study and process evaluation (CHOICE Study)

This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (NIHR127869). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

ABOUT THE  CHOICE STUDY

The CHOICE study is a non-commercial study, sponsored by the University of Edinburgh and funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme.

Induction of labour (IOL) is the most common obstetric intervention, offered to women when risks of continuing the pregnancy are thought to outweigh risks of delivery. Rates of IOL were above 40% in the 1970s, but halved over the next decade, before increasing again from the late 1990s.  Current IOL rates mean that 30.6% of pregnant women in the UK have their labour induced.

Cervical ripening is a key component of IOL, whereby application of a drug or mechanical method over a number of hours, causes softening, shortening, and opening of the cervix in preparation for labour. Traditionally cervical ripening has been performed entirely in-hospital, to allow monitoring of mother and baby, and to recognise complications.  However, an increasing number of maternity units offer home cervical ripening, whereby women attend hospital for initial assessment and administration of cervical ripening agent; and then return home for a period of time (usually 24 hours), before reassessment in hospital. Home cervical ripening has the potential to reduce hospital stay during IOL, reducing costs to health services, and maybe more acceptable to women. However, this has not been fully evaluated, and possible benefits could be offset by increased costs of any additional morbidity resulting from home cervical ripening, costs to parents may be increased; and acceptability of home cervical ripening is unknown. Health services need to balance the full resource impact of IOL with the need to provide safe and acceptable care.

RESEARCH QUESTIONS AND METHODS

In the CHOICE study we address the question “Is it safe, effective, cost-effective and acceptable to women to carry out home cervical ripening during IOL?”

We will perform:

De-identified data on all women having IOL from 37 weeks onwards will be extracted from participating sites.  Women will be informed that the study is active in their maternity unit, and informed how they can opt-out if they do not want their data to be included in the study.  All women in participating sites will be invited to take part in the online patient questionnaire, and in 5 of the study sites we will also conduct interviews with women, partners and health professionals.

MEET THE TEAM

The study is led by Dr Sarah Stock, Wellcome Trust Clinical Career Development Fellow, and managed by the Edinburgh Clinical Trials Unit (ECTU).

Dr Sarah Stock leads the observational data cohort component of the protocol and Professor Helen Cheyne and Professor Christine McCourt lead the qualitative component (qCHOICE).

Dr Sarah Stock

Dr Sarah Stock

Chief Investigator

Professor Helen Cheyne

Professor Helen Cheyne

Co-Investigator

Dr Cassandra Yuill

Dr Cassandra Yuill

Research Fellow

Dr Mairi Harkness

Research Fellow

Maggie Reid

CHOICE Research Midwife

Fiona Wee

Trial Manager

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