Birth options feasibility trial
| ISRCTN | ISRCTN55288596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55288596 |
| Integrated Research Application System (IRAS) | 345836 |
| Central Portfolio Management System (CPMS) | 70096 |
| National Institute for Health and Care Research (NIHR) | 302530 |
| Sponsor | University of Liverpool |
| Funder | National Institute for Health and Care Research |
- Submission date
- 15/12/2025
- Registration date
- 23/01/2026
- Last edited
- 23/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Many women in England have caesarean births – about 42% of all births, and more than half of these are emergency operations. Emergency caesareans can sometimes lead to birth trauma. Women say they want clearer information to help them make choices about how they give birth.
This study looks at whether it is possible to run a larger trial comparing three approaches: usual care, a guided conversation about birth options, and a guided conversation plus a tool that predicts the chance of needing an emergency caesarean. In the long term, the study aims to see if these approaches affect how satisfied women feel with their choices and whether emergency caesareans become less common.
Who can participate?
Women who are between 28 and 37 weeks pregnant with their first ongoing pregnancy are invited to take part.
What does the study involve?
Participants fill in a questionnaire between 28 and 36+6 weeks of pregnancy. They are then randomly placed into one of three groups:
1. Usual care
2. A guided conversation about birth options
3. A guided conversation plus a prediction tool for emergency caesarean
The conversation takes place at around 36 weeks. After that, participants can choose vaginal birth, induction, or planned caesarean. The study team collects feedback from participants and their midwives or doctors, and gathers information about pregnancy and birth. Participants also complete short questionnaires about mental health and birth expectations after the conversation, and about experience and mental health at 6 weeks and 6 months after the baby is born.
What are the possible benefits and risks of participating?
Taking part may help participants feel more informed and confident about their birth choices. The study could also improve care for future mothers. There are no major risks from taking part, but the conversations and questionnaires may take some time and could feel sensitive for some people.
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
January 2026 to September 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Abi Merriel, BirthOptions@liverpool.ac.uk
Contact information
Public, Scientific, Principal investigator
Department of Women’s and Children’s Health, University of Liverpool, First Floor Liverpool Women’s Hospital, Crown Street
Liverpool
L8 7SS
United Kingdom
| Phone | +44 (0)7801259569 |
|---|---|
| BirthOptions@liverpool.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised cohort study |
| Secondary study design | Randomised controlled trial |
| Scientific title | A three-arm randomised feasibility trial of birth options interventions to predict, inform and offer choices to reduce emergency caesarean birth in first pregnancies |
| Study objectives | Aim: To establish if it is possible to implement the Birth Options Interventions and recruit and retain participants in the Birth Options feasibility trial Objectives: 1. What is the recruitment rate to the Birth Options Feasibility Trial? 2. What proportion of women and birthing people complete follow up? 3. Is the Birth Options intervention acceptable to families and clinical staff? 4. What are the reasons for participation/non-participation in the study? 5. How can recruitment to a main trial be optimised? 6. What proportion of women opt for each birth option? 7. Is it feasible to collect the proposed outcome measures for a follow-on trial to evaluate clinical and cost-effectiveness. 8. Exploratory analysis of the proposed outcome measures and characteristics associated with choice of option. 9. What do participants think of the intervention and are any refinements needed? |
| Ethics approval(s) | Approved 27/11/2025, South East Scotland Research Ethics Committee 01 (Headquarters, Mainpoint, 102 West Port, Edinburgh EH3 9DN, UK; Tel: not applicable; Sandra.Wyllie@nhs.scot), ref: 25/SS/0100 |
| Health condition(s) or problem(s) studied | Birth options |
| Intervention | There are three parts to this study: 1. Randomised feasibility trial 2. Intervention development 3. Alongside recruitment intervention 1. Randomised feasibility trial: 180 women will be recruited across three sites and randomised into either: usual care, clinical conversation or prediction of emergency caesarean plus clinical conversation. All women will be asked to complete a baseline questionnaire, a questionnaire around 35-37 weeks of pregnancy, a questionnaire at 6 weeks and then 6 months postnatally. Women in the clinical conversation group will be invited in for a clinical conversation and offer of birth options between 35 and 37 weeks. Women in the prediction + clinical conversation group will either attend for the prediction results and clinical conversation as per above OR attend for an ultrasound scan if they have not already had one in the study window alongside (ideally at the same attendance)the clinical conversation or will attend a further appointment for a clinical conversation with the prediction model if it cannot be facilitated on the same day. Baseline demographics and outcome data will be collected by the site teams. 2. Intervention development: This will be for the clinical conversation (60 participants) and clinical conversation + prediction arms (60 participants). After the intervention women will be asked to complete a questionnaire to feedback on the intervention. We will invite 20 women to an interview after the intervention to feedback on it and 20 women to an interview postnatally to feedback in the context of their birth experience. Alongside this we will ask staff providing the intervention to complete a fidelity questionnaire for each clinical conversation. We will also hold a focus group with staff at each site about the intervention and how to refine it. 3. Alongside recruitment intervention This is used to try to optimise recruitment processes for a main trial. We will record recruitment conversations at each site and analyse these to try to identify elements of successful recruitment conversations. Verbal consent will be sought for this. We will interview upto 20 women who decline participation, 20 who drop out and 20 who complete the study. We will also use the post intervention questionnaires and interviews (mentioned in fidelity section) to understand views on participation/recruitment. We will also interview recruiting staff and map the study flow at participating sites |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. Recruitment rate to the Birth Options Feasibility Trial: number of recruits per month reported at study close |
| Completion date | 30/09/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 99 Years |
| Sex | Female |
| Target sample size at registration | 180 |
| Key inclusion criteria | Women participating in the trial: 1. From 28+0 weeks – 36+6 completed weeks of pregnancy 2. In first ongoing pregnancy past 22+0 weeks 3. Singleton pregnancy 4. 16 years or older Staff/clinicians delivering the intervention: 1. Clinical (Doctors and Midwives) staff delivering study intervention or recruiting to the study Staff recruiting to the study: 1. Research or clinical staff recruiting to the study |
| Key exclusion criteria | Women participating in the trial: 1. Having a pre-existing plan for planned caesarean 2. Having a clinical indication that would likely necessitate a planned caesarean, e.g., placenta praevia/accreta 3. Multiple pregnancies 4. Less than 16 years old 5. Not in first ongoing pregnancy Staff/clinicians delivering the intervention: 1. No active participation in the study Staff recruiting to the study: 1. No active participation in the study |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 31/03/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Crown Street
Liverpool
L8 7SS
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
16/12/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
