Condition category
Pregnancy and Childbirth
Date applied
03/07/2020
Date assigned
10/07/2020
Last edited
10/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Induction of labour (IOL) is the most common obstetric intervention offered to women when the risks of continuing the pregnancy are thought to outweigh the risks of delivery. Increases in IOL rates mean that 30.6% of pregnant women in the UK have their labour induced. Cervical ripening is a key component of IOL, where a drug or mechanical method applied 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 maternal/fetal wellbeing and recognition of complications. However, an increasing number of maternity units offer home cervical ripening, where women attend hospital for initial assessment and administration of the cervical ripening agent and then return home (to her own home, or that of a friend/relative/birth partner) 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. However, the safety and acceptability of home cervical ripening have not been fully evaluated. Potential NHS cost savings could be offset by increased costs of any additional illness resulting from home cervical ripening, costs to parents may be increased, and the 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. The aim of this study is to find out whether it is safe, effective, cost-effective and acceptable to women to carry out home cervical ripening during IOL.

Who can participate?
Women with single pregnancies having IOL at or beyond 39 weeks gestation

What does the study involve?
This study will use anonymised routinely collected health data from electronic maternity records systems. Patients will also be asked to complete an online survey, and a smaller group of these patients will be asked if they would like to be interviewed by the researcher.

What are the possible benefits and risks of participating?
Patients will be able to opt-out if they do not want their data to be included in the study. As such there are no direct risks of taking part. It is possible that for some women, answering questions may bring back stressful or emotional memories. However, the questionnaire is comprised of questionnaires that have been frequently used and found to be acceptable in similar populations, and interviews with women and their partners will be undertaken by experienced research staff who will be sensitive to participants who appear to be distressed.

Where is the study run from?
University of Edinburgh (Edinburgh Clinical Trials Unit), University of Stirling and City, University of London (UK)

When is the study starting and how long is it expected to run for?
December 2019 to November 2022

Who is funding the study?
National Institute for Health Research Health Technology Assessment (NIHR HTA) (UK)

Who is the main contact?
Fiona Wee
CHOICE.Study@ed.ac.uk

Trial website

https://www.ed.ac.uk/usher/edinburgh-clinical-trials/our-studies/ukcrc-studies/choice

Contact information

Type

Scientific

Primary contact

Dr Sarah Stock

ORCID ID

http://orcid.org/0000-0003-4308-856X

Contact details

Usher Institute
University of Edinburgh
NINE Edinburgh BioQuarter
9 Little France Road
Edinburgh
EH16 4UX
United Kingdom
+44 (0)131 242 6449
sarah.stock@ed.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

AC20020, HTA - NIHR127569

Study information

Scientific title

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

Acronym

CHOICE

Study hypothesis

The aim is to compare home versus in-hospital cervical ripening 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 from both NHS and patient perspectives.

Ethics approval

Approved 17/06/2020, York & Humber – Sheffield Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 1048084; sheffield.rec@hra.nhs.uk), ref: 20/YH/0145

Study design

Prospective multicentre observational cohort study, with internal pilot phase, using data obtained from hospital electronic health records, a cost-effectiveness analysis, and a questionnaire-based survey and nested case studies evaluating process and women/partner experiences

Primary study design

Observational

Secondary study design

Nested process evaluation study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Women with singleton pregnancies having induction of labour at or beyond 39 weeks gestation

Intervention

Observational cohort:
The researchers will include at least 14 maternity units offering only in-hospital cervical ripening and at least 12 offering dinoprostone home cervical ripening. They will concurrently collect data from at least four maternity units offering balloon catheter home cervical ripening to allow initial exploratory comparison of these two different methods of cervical ripening. To achieve a sufficiently sized cohort for analysis (taking into account the need for statistical techniques to reduce biases inherent in observational studies) and maximise the value and generalisability of the study, the researchers will collect data from a large and broad cohort of women having IOL.

Women will be informed about the study through a variety of methods including posters in participating sites, information leaflets, online adverts on hospital/maternity websites and relevant social media sites, and information in maternal electronic maternity records (for women who can access their own maternity record). Women will be able to opt out of the study by informing their midwife or by emailing an independent study contact. Details of how to opt out will be included in the study materials.

De-identified data will be extracted from the BadgerNet Maternity system data on all eligible women having IOL, from multiple existing data fields, supplemented by new bespoke, data entry fields enabled in participating sites. Data from women who have opted out will not be included in the extraction. All data will be securely transferred to the CHOICE database for analysis. Linked NNU admission data will be obtained from the National Neonatal Research Database.

The researchers propose a pilot phase to determine the parameters of the primary outcome and achievability of obtaining the required sample size for analysis. They will perform an analysis after 6 months of recruitment (evaluable target 600 women in each arm), and will assess variation of the primary outcome at the pilot stage; along with that of other measures of neonatal morbidity included as secondary outcomes.

Analysis of data for outcome measures will be performed by the trial statistician.

qCHOICE
A process evaluation seeks to understand and explain the ways in which interventions such as cervical ripening are implemented, and how they work in different contexts. The context in which an intervention is implemented (e.g geography, socio-economics and work culture) is a major factor impacting on outcomes both planned and unplanned. Therefore it is important to study how cervical ripening is being undertaken, and its impact on psychosocial and economic outcomes in different contexts.

To do this the researchers will use a survey and multiple case study design. Both qualitative and quantitative data will be collected - specifically, a questionnaire, semi-structured interviews with women and birth partners, audio recordings of clinician/women consultations, interviews and focus-group discussions with professionals and service managers/commissioners.

The questionnaire will be administered in at least 12 sites particpating in the observational cohort study. The survey will involve women who have experienced labour induction. It will assess differences between setting +/- method of cervical ripening in terms of women’s satisfaction, experience, and psychosocial outcomes. A consecutive sample of women who had any form of IOL involving cervical ripening will be invited to complete the survey online or by post around 4-6 weeks postnatally. The questionnaire will comprise validated tools plus a small number of questions relating to service user costs, some information about their IOL and will ask women to indicate their willingness to be contacted for a subsequent interview (case study sites only).

Case studies will be performed in five of the observational cohort study sites: two in Scotland and three in England. The case study sites will be maternity services. We will select sites that vary by size (i.e. annual births), by policy for cervical ripening (home or hospital) and by sociodemographic and geographical characteristics.

Within each site the researchers will undertake semi-structured interviews to assess the acceptability of home CR to women, their families and other key stakeholders, explore women and partners lived experience of CR (home or hospital) IOL and subsequent labour and assess the local pathways and processes involved in decision making about home/hospital CR, identifying barriers and enablers in different contexts. Individual interviews with stakeholders and senior professionals will be semistructured, conducted face-to-face, skype or by telephone and audio-recorded.

To provide a more in-depth understanding of the acceptability of home cervical ripening, and of the discussion and decision-making processes involved in potentially offering home cervical ripening to women we will audio record a sample of antenatal consultations between obstetricians or midwives and women/partners in which IOL will be discussed.

The process evaluation component of the study will also collect key data for the economic evaluation; namely, costs incurred by women in relation to IOL, for all modes but with a particular focus on home CR.

These will be collected through the inclusion of costing questions in the women’s postnatal survey and more in-depth discussion in interviews, in order to enhance interpretation.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Observational study:
Admission to neonatal unit (NNU) within 48 hours, for a period of 48 hours or more, measured using patient records at a single timepoint

qCHOICE:
Sense of control (agentry) in labour, based on the use of the labour agentry scale which will form part of the patient questionnaire at a single timepoint

Secondary outcome measures

Measured using patient records at a single timepoint:
1. Neonatal morbidities
2. Maternal morbidities
3. Mode of birth
4. Time of birth
5. Duration of hospital stay
5. Breastfeeding

Health economic outcomes will form part of the patient questionnaire, and will be measured by patient-related resource use and expenditures of cervical ripening for women

Overall trial start date

01/12/2019

Overall trial end date

30/11/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Observational study:
For data collection:
1. Gestation 37+0 weeks or more
2. Undergoing IOL
For primary analysis:
1. Gestation of 39+0 weeks or more

Qualitative study:
For questionnaire-based survey:
1. Gestation 39+0 weeks or more
2. Undergoing IOL
For case studies:
1. Gestation of 39+0 weeks or more

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Observational study: The primary analysis sample size is 8,533 women with uncomplicated pregnancies at 39 weeks or more undergoing IOL. To achieve this, and to put our findings into context, we will collect data on a much broader cohort of around 41,000 women having IOL after 37 weeks. Qualitative study: The sample size required to compare the experiences of women who had home and hospital cervical ripening is estimated to be 89 per group (178 in total). The sample sizes for the case studies, interviews, focus groups and recordings of visits are pragmatic and based on an estimation of numbers needed in a purposive sample to achieve data saturation.

Participant exclusion criteria

Observational study:
For data collection:
1. Opted out of data provision (checkbox)
Applied for primary analysis:
1. Grand multiparity (6 or more previous pregnancies)
2. Previous caesarean section
3. Antepartum stillbirth (before cervical ripening initiated)
4. Class III obesity at booking (BMI 40 kg/m2 or more)
5. Prelabour rupture of membranes documented as primary or other indication for IOL (prolonged ROM; SROM; ?SROM)
6. Maternal, fetal or medical condition that would/could preclude home cervical ripening documented as primary or other indication for IOL
7. Maternal conditions: proteinuria; hypertension; antepartum haemorrhage; diabetes; obstetric cholestasis; past obstetric history; pre-eclampsia; PIH/PET (not defined); PIH; PET; thrombophilia
8. Fetal conditions: oligohydramnios; reduced liquor volume; macrosomia; intrauterine growth restriction (IUGR); static growth; congenital fetal anomaly; polyhydramnios; abnormal CTG/Doppler; breech; reduced fetal movements; termination of pregnancy for fetal anomaly

Qualitative study:
For case studies:
1. Women who did not have IOL at 39+0 weeks of gestation
2. Women who had IOL for medical reasons
3. Women who had an elective cesarean section
4. Women who have experienced intrauterine death, stillbirth or neonatal death

Recruitment start date

01/09/2020

Recruitment end date

01/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Edinburgh Clinical Trials Unit
Usher Institute, University of Edinburgh NINE Edinburgh BioQuarter, 9 Little France Road
Edinburgh
EH16 4UX
United Kingdom

Sponsor information

Organisation

University of Edinburgh

Sponsor details

Research & Development Management Suite
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)1312426226
Jo-Anne.Robertson@ed.ac.uk

Sponsor type

University/education

Website

http://www.ed.ac.uk/home

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

30/11/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/07/2020: Trial's existence confirmed by the NIHR.