EQUIBIRTH project: improving choice, informed consent and respect from individuals from ethnic minority communities accessing maternity care
| ISRCTN | ISRCTN18245268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18245268 |
| Integrated Research Application System (IRAS) | 341434 |
| Grant number | 23GOB023 |
| Sponsor reference | 25OB001 |
| Sponsor | Nottingham University Hospitals NHS Trust |
| Funder | Nottingham Hospitals Research Charity |
- Submission date
- 03/03/2026
- Registration date
- 14/04/2026
- Last edited
- 14/04/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
In England and Wales, one in four women giving birth are from ethnic minority groups. Research shows that many of these individuals encounter similar problems when accessing maternity care. These include not being listened to, limited choice, lack of informed consent, and experiences of discrimination. Such experiences can have lasting effects, like avoiding care, mistrusting health staff, fearing future pregnancies, or developing long-term health issues.
The EquiBirth project aims to understand how we can improve choice, consent, and respect for ethnic minority women in NHS maternity care and in what situations these approaches work best.
Who can participate?
1. Individuals who have accessed or are accessing NHS maternity care from any of the following ethnic communities:
1.1. Black (this may include individuals who identify as having a British, African, Caribbean or different heritage)
1.2. Asian (this may include individuals who identify as Indian, Pakistani, Bangladeshi, Chinese or a different heritage)
1.3. Mixed race (e.g., individuals with mixed heritage, e.g., Asian and White), or
1.4. Identify as belonging to another ethnic minority community not mentioned above, e.g., Arab or Kurdish
2. Healthcare professionals who work with women from ethnic minority communities who are accessing/have accessed NHS maternity care
3. Individuals who have a management or leadership role in healthcare at an institutional, regional or national level, e.g., you may work for a Local Maternity and Neonatal System (LMNS) or an Integrated Care Board
4. Representatives from charities or organisations that works with, support or represents individuals from ethnic minority communities who may access or have accessed NHS maternity care
What does the study involve?
The study involves different activities. Participants can take part in one activity, or more than one. The activities include:
1. Focus groups
2. Workshops
3. Interviews
4. Observations of health care encounters
5. Online survey
6. Completion of patient-reported outcome measures (short surveys)
What are the possible benefits and risks of participating?
Right now, we don't know the best way to improve information, choice and respect for individuals from ethnic minority communities accessing NHS maternity care. The EquiBirth study wants to help find the answers. Making improvements takes time. This means the people taking part might not see the benefits themselves, but we hope the study will help improve care for women and families in the future.
Taking part will take up some of your time. Focus groups and workshops will be held in community venues in Nottingham, so some travel may be required. Up to £10 will be available for travel costs.
It is possible that sensitive topics may come up in discussions. The study is looking at how we can improve information provision, informed consent and respect. It is possible that you or someone at a session may have experienced care where informed consent was not sought, or the care provided was not respectful. If at any point you find a conversation uncomfortable or distressing, you have several options. You can:
1. Take a break from a session
2. Chose not to answer a question/take part in a discussion
3. Withdraw from the session
If you find any part of a session uncomfortable or distressing, please let a member of the research team know. The chief investigator is an experienced health professional and will be on hand to provide support if needed. The research team can also signpost you to appropriate support services. If you choose to withdraw from a session, you will be offered a telephone call a few days later by the chief investigator to see how you are doing. You are welcome to contact the study team anytime during the study by emailing Naomi.Taylor5@nhs.net. The research team can help you access support.
All group sessions will be facilitated by professionals with experience of running group sessions. At the start of group sessions, the group will be asked to agree on a code of conduct for the session. You will be asked not to share what is said by individuals at the session with those not at the session. You will also be asked not to share another individual’s medical information or experiences without their explicit consent. At the start of an interview or group session a member of the research team will remind you of your options (as outlined above) in case you feel uncomfortable or distressed.
Community involvement is central. A steering group including people from ethnic minority backgrounds with maternity experience, service users, and professionals will guide the project. They will help shape the design, materials, recruitment, and sharing of results. EquiBirth will also work with The Essential Baby Company, which amplifies the voices of Black and Brown women in maternity research.
This project will form a PhD thesis. Findings will be published in journals, presented at conferences, and shared on the EquiBirth website. Participants can choose to receive results in a newsletter available in the five most spoken languages.
Where is the study run from?
Nottingham University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2026 to July 2030
Who is funding the study?
Nottingham Hospitals Research Charity (UK)
Who is the main contact?
Dr Naomi Taylor, Naomi.Taylor5@nhs.net
Contact information
Public, Scientific, Principal investigator
Fetal Medicine Department
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)1159249924 ext 80460 |
|---|---|
| naomi.taylor5@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | The study consists of three work programmes (WPs): WP1 is a realist review; WP2 involves the co-development of interventions that can be used to test the programme theories in WP3 via co-design workshops, and assessment of acceptability and feasibility of the realist evaluation using a mixed methods case study design; WP3 involves a realist evaluation using a mixed methods case study design. |
| Secondary study design | |
| Scientific title | EQUIBIRTH project: what works, for whom and in what circumstances when it comes to improving choice, informed consent and respect for individuals from ethnic minority communities accessing maternity care. A realist review and realist evaluation |
| Study acronym | EquiBirth Project |
| Study objectives | Research question: What works, for whom and under what circumstances when it comes to improving choice, informed consent and respect for individuals from ethnic minority communities accessing UK maternity care? Aims: 1. To produce transferrable learning in the form of refined programme theory about what works, for whom and under what circumstances when it comes to improving choice, informed consent and respect for individuals from ethnic minority communities accessing UK maternity care 2. To produce evidence-based recommendations for NHS services outlining how they can improve choice, informed consent and respect for individuals from ethnic minority communities accessing care in different maternity contexts 3. To work with service users, professionals and wider stakeholders to co-produce and evaluate interventions that aim to improve choice, informed consent and respect for individuals from ethnic minority communities accessing UK maternity care in different contexts Objectives: Work programme one: realist review The purpose of the review is to: 1. Identify and categorise the different programme theories (mechanism-context-outcome [M-C-O] configurations) present in the literature that are relevant to improving information provision, informed consent and respect for individuals from ethnic minority communities accessing UK maternity care. The programme theories will be categorised according to their proposed mechanism of action. Programme theories with similar mechanisms will be grouped together. 2. To select a manageable number of programme theories (up to five) with complementary mechanisms of action for investigation. Programme theories will be selected based on their ability to inform improvements in the provision of accessible information, informed consent and respect for individuals from ethnic minority communities accessing NHS maternity care. 3. To use data on the programme theories in different contexts (maternity settings/sub-groups) to advance our understanding of: 3.1. How and why the programmes work 3.2. Who benefits from which programme theory in which context 3.3. The key contextual features that support or hinder the programme mechanisms Work programme two involves co-development and refinement of interventions that can be used to test and refine the programme theories selected during WP1 and assessment of the acceptability and feasibility of (1) programme theories (2) Interventions developed to test and refine the programme theories (3) the proposed realist evaluation Primary objectives: 1. To use data collected in real-world settings to test and refine the interventions 2. To assess the acceptability and feasibility of the underlying programme theories and intervention components in different contexts 3. To use the outputs from WP1, co-design workshops and the testing of intervention ideas to co-design interventions that are acceptable and feasible and suitable for use in the realist evaluation 4. To involve stakeholders in the design of the interventions. The involvement of stakeholders will increase the likelihood that the interventions are acceptable, feasible and effective 5. To assess the acceptability and feasibility of the evaluation design outlined in WP3 Secondary objectives: 1. To test and refine the underlying programme theories 2. To determine the contextual features (physical, social, cultural, organisational, digital, political or economic) that promote/hinder the activation of programme mechanisms 3. To explore how the intervention may influence the context in which it is implemented, including any unintended consequences and potential harms 4. To understand facilitators and barriers to reaching the relevant population, future use of the intervention, scale-up and sustainability in real-world contexts Work programme three: realist evaluation Primary objectives: 1. To test and refine programme theory, i.e., mechanism (M), context (C) and outcome (O) configurations 2. To determine the contextual features (physical, social, cultural, organisational, digital, political or economic) that influence the activation of programme mechanisms Secondary objectives: 1. To explore how the intervention may influence the context in which it is implemented, including any unintended consequences or potential harms 2. To understand facilitators and barriers to future implementation, including reaching the relevant population, scale-up and sustainability in real-world contexts 3. To involve stakeholders at each stage of the evaluation process to maximise the likelihood that the evaluation addresses relevant questions, measures appropriate outcomes and leads to changes in practice and policy 4. To provide recommendations about how improvements in respect, choice and informed consent may be facilitated for individuals from ethnic minority communities accessing maternity care in the different contexts in which UK maternity care is provided |
| Ethics approval(s) |
Approved 19/08/2025, South Central - Oxford B Research Ethics Commitee (Health Research Authority, 2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 (0)2071048032; oxfordb.rec@hra.nhs.uk), ref: 25/SC/0228 |
| Health condition(s) or problem(s) studied | Maternity services |
| Intervention | The interventions used to test the programme theories will be co-developed as part of the project and will depend upon the realist programme theories selected in work programme two. The project has three parts: Work Programme 1 (WP1): Realist Review Review existing studies to find and test theories that explain how and why different changes work, who benefits, and under what conditions. Work Programme 2 (WP2): Co-development and testing of acceptability and feasibility Work with communities to design and refine resources that test the chosen theories. Check if these resources and approaches are acceptable and practical. Work Programme 3 (WP3): Realist Evaluation Use case studies in different settings to test the theories. Collect data through interviews, observations, surveys, and patient-reported outcomes. Realist methods will be used because they explain how and why programmes work and what conditions support success. Case studies allow in-depth research in real-life settings. What does taking part involve? The study involves different activities. Participants can take part in one activity, or more than one. The activities include: 1. Focus groups 2. Workshops 3. Interviews 4. Observations of health care encounters 5. Online survey 6. Completion of patient-reported outcome measures (short surveys) Data analysis: Qualitative data will be used to explore quantitative findings, and quantitative data will be used to test hypotheses generated from qualitative data. A realist logic of analysis will be applied to examine context–mechanism–outcome relationships and refine programme theory, using Pawson’s analytic techniques. Qualitative data will also be analysed thematically. Quantitative data will be analysed using descriptive statistics, with Statistical Process Control (SPC) charts used to assess changes in PROMs over time. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
WP1: Data from included studies that relates to context-mechanism-outcome or the relationship between these, extracted from the included studies between months 11 and 14 of the realist review. |
| Key secondary outcome measure(s) |
WP2: Data on acceptability and feasibility of the co-designed interventions and realist evaluation; contextual facilitators and barriers to implementation; potential unintended consequences or harms; factors influencing engagement, implementation and sustainability; and stakeholders' perspectives on what constitutes a meaningful improvement in patient-reported outcome measures based on data collected from the co-design workshops (months 22-27 and 34-37) and the mixed-method case studies (months 28-35). |
| Completion date | 31/07/2030 |
Eligibility
| Participant type(s) | Health professional, Patient, Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 570 |
| Key inclusion criteria | 1. From one of the following populations: Service users: Individuals from any of the following ethnic communities: 1. Black (this may include individuals who identify as having a British, African, Caribbean or different heritage) 2. Asian (this may include individuals who identify as Indian, Pakistani, Bangladeshi, Chinese or a different heritage) 3. Mixed race (e.g., individuals with mixed heritage, e.g., Asian and White), or 4. Identify as belonging to another ethnic minority community not mentioned above, e.g., Arab or Kurdish AND 5. Are accessing or have accessed NHS maternity care Additional stakeholders: 1. Healthcare professionals who work with women from ethnic minority communities who are accessing/have accessed NHS maternity care 2. Individuals who have a management or leadership role in healthcare at an institutional, regional or national level e.g., you may work for a Local Maternity and Neonatal System (LMNS) or an Integrated Care Board 3. Representatives from charities or organisations that works with, support or represents individuals from ethnic minority communities who may access or have accessed NHS maternity care 2. Aged 16 years and over 3. Able to provide informed consent |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 15/04/2026 |
| Date of final enrolment | 31/12/2029 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Derby Road
Nottingham
NG7 2UH
England
Hucknall Road
Nottingham
NG5 1PB
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
03/03/2026: Study's existence confirmed by the South Central - Oxford B Research Ethics Commitee.
