CHOICE
Research type
Research Study
Full title
Cervical Ripening at Home or In-Hospital - prospective cohort study and process evaluation (CHOICE study)
IRAS ID
276788
Contact name
Sarah Stock
Contact email
Sponsor organisation
The University of Edinburgh
Clinicaltrials.gov Identifier
TBC, ISRCTN
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
In most pregnancies labour starts on its own, but sometimes induction of labour (IOL) is needed. The first part of IOL is ‘cervical ripening’, where medication or a specialised balloon is used to prepare the cervix (neck of the womb) for labour.
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 procedure started off in hospital, then spend some time at home whilst waiting for the treatment to work. This may help reduce demands on maternity services and reduce the time women spend in hospital. Women may also prefer it. However, benefits are not proven. Home cervical ripening may be riskier for mother and babies, as some rare complications may not be detected when women are at home.
We aim to see if home cervical ripening is safe, 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 IOL in 30 UK maternity units. Women will be given information about the study and can choose to opt out in which case their data will not be used. For babies that need special care after birth, we will get data from a large, national database of baby records, the National Neonatal Research Database (NNRD).
We will use qualitative methods toassess the acceptability of home cervical ripening and explore women’s experiences of IOL. We will undertake a survey in 12 sites to assess women’s experience of IOL, psychological sequelae, and associated costs. In five sites, we will also conduct interviews with women, partners and health professionals. We will audio record a sample of consultations where IOL is discussed to assess how practitioners involve women in decision making.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0145
Date of REC Opinion
17 Jun 2020
REC opinion
Further Information Favourable Opinion