Birth options feasibility trial

A three-arm randomised feasibility trial of birth options interventions to predict, inform and offer choices to reduce emergency caesarean birth in first pregnancies

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55288596

Enrollment

180

Registered

2026-01-23

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth options Pregnancy and Childbirth

Interventions

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 ac

Eligibility

Sex/Gender

Female

Age

16 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
1. Recruitment rate to the Birth Options Feasibility Trial: number of recruits per month reported at study close 2. Completion of follow-up to the Birth Options Feasibility Trial: number of women completing the study at study close 3. Acceptability of Birth Options intervention to families and clinical staff: examined using surveys post intervention and qualitative interviews post intervention 4. Reasons for non-participation/non-participation: examined using qualitative interviews at the point of declining to participate 5. Optimisation strategies for recruitment to a main trial: identified via qualitative interviews at the time of decline, drop out, completion and with study staff at the end of the trial 6. Proportion of women opting for each birth option recorded after consultation 7. How complete was the collection of proposed outcome measures: number of surveys completed, completeness of case report form at end of study follow-up. 8. Exploratory analysis of the proposed outcome measures and characteristics associated with choice of option: demographic, clinical and experience outcomes reported by intended and actual mode of birth at 6 weeks and 6 months postnatally. 9. What was the feedback on the intervention and suggested refinements: collected via qualitative interviews following intervention and post birth for women and at the end of recruitment for staff.	—

Measure

Time frame

1. Recruitment rate to the Birth Options Feasibility Trial: number of recruits per month reported at study close 2. Completion of follow-up to the Birth Options Feasibility Trial: number of women completing the study at study close 3. Acceptability of Birth Options intervention to families and clinical staff: examined using surveys post intervention and qualitative interviews post intervention 4. Reasons for non-participation/non-participation: examined using qualitative interviews at the point of declining to participate 5. Optimisation strategies for recruitment to a main trial: identified via qualitative interviews at the time of decline, drop out, completion and with study staff at the end of the trial 6. Proportion of women opting for each birth option recorded after consultation 7. How complete was the collection of proposed outcome measures: number of surveys completed, completeness of case report form at end of study follow-up. 8. Exploratory analysis of the proposed outcome measures and characteristics associated with choice of option: demographic, clinical and experience outcomes reported by intended and actual mode of birth at 6 weeks and 6 months postnatally. 9. What was the feedback on the intervention and suggested refinements: collected via qualitative interviews following intervention and post birth for women and at the end of recruitment for staff.

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Countries

England, United Kingdom

Contacts

Public ContactAbi Merriel

BirthOptions@liverpool.ac.uk+44 (0)7801259569

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026