Building a safe space: optimising maternity care for survivors of modern slavery by co-creating supporting resources for women and professionals
| ISRCTN | ISRCTN28610053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28610053 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Nottingham |
| Funder | Research for Patient Benefit Programme |
- Submission date
- 12/07/2024
- Registration date
- 03/02/2025
- Last edited
- 14/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Modern slavery is the exploitation of individuals through activities such as sexual exploitation, forced labour, forced criminal activity, the sale of children and the forced movement of people via human trafficking. Estimates suggest up to 122,000 adults live in modern slavery in the UK, with over 18,400 women and girls confirmed as potential victims since 2018. Around three in every ten women survivors of modern slavery are pregnant while being trafficked. These women and their babies are more likely to experience poor health outcomes. All childbearing women should receive care that is respectful, safe and appropriate to their situation. Maternity care professionals have limited knowledge about how best to provide care for survivor mothers. Collaborative working between maternity services and community agencies requires support.
We want to understand how the best maternity care and support can be provided for survivor mothers and their babies.
Who can participate?
Survivor mothers who have experience of maternity care in the UK.
Maternity professionals (working clinically or strategically) and non-statutory service staff providing care and support to women survivors.
What does the study involve?
We will work with organisations that support women survivors nationally to complete interviews or focus groups with up to 22 survivor mothers from varied backgrounds and cultures. We will also interview up to 8 staff in total from support agencies and maternity professionals. We will be flexible in how we work with everyone. Women will have access to emotional and language support, anonymity will be maintained, and survivors’ time will be paid for. We will use recognised approaches to analyse the data collected. From this information, we will co-create with stakeholders best practice resources to support women’s decision-making and guide those providing care and support during maternity.
What are the possible benefits and risks of participating?
We cannot promise that the study will be of direct help to the participants, but the information we get from this study may help improve future care provision for women and their babies. Some participants enjoy taking part in interviews and sharing their views and experiences. There are few risks involved in interviews/focus group research, including emotional distress. We ask that people only share what they are comfortable with. If the participants become distressed during the interview/focus group due to the sensitive nature of the discussion, they will be free to pause or terminate their participation.
Where is the study run from?
University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
June 2024 to December 2025
Who is funding the study?
NIHR Research for Patient Benefit and Salvation Army (UK)
Who is the main contact?
Dr Sara Borrelli, sara.borrelli@nottingham.ac.uk
Contact information
Public, Scientific, Principal investigator
School of Health Sciences
The University of Nottingham
B Floor, Room B236, Queen’s Medical School
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0003-0826-5516 |
|---|---|
| sara.borrelli@nottingham.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Qualitative study |
| Secondary study design | Qualitative study |
| Study type | Participant information sheet |
| Scientific title | Building a safe space: optimising maternity care for survivors of modern slavery by co-creating supporting resources for women and professionals |
| Study objectives | Project aims: 1. To identify how optimal maternity care and support should be provided for survivor mothers and their babies 2. To co-create recommendations and resources for survivor mothers, maternity professionals and non-statutory service staff. |
| Ethics approval(s) |
1. Approved 25/06/2024, University of Nottingham, Faculty of Medicine and Health Sciences Ethics Committee (Faculty Hub, Room E41, E Floor, Medical School, Queen's Medical Centre Campus, Nottingham University Hospitals, Nottingham, NG7 2UH, United Kingdom; -; FMHS-ResearchEthics@nottingham.ac.uk), ref: FMHS 191-0524 2. Submitted 09/07/2024, The Salvation Army, Research & Development Unit (Territorial Headquarters, 1 Champion Park, London, SE5 8FJ, United Kingdom; -; rdu@salvationarmy.org.uk), ref: - |
| Health condition(s) or problem(s) studied | Maternity care and support for survivor mothers and their babies |
| Intervention | In depth, semi-structured, audio-recorded face-to-face/virtual interviews or focus groups (depending on participant preference) with survivor mothers; in-depth, semi-structured, recorded virtual interviews with professionals; template analysis; co-creation. |
| Intervention type | Other |
| Primary outcome measure(s) |
To identify how optimal maternity care and support should be provided for survivor mothers and their babies measured using qualitative interviews and focus groups |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Health professional, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 34 |
| Key inclusion criteria | Survivor mothers: 1. Experience of maternity care in the UK (pregnancy or labour or postpartum) 2. Self-identify or identified by professionals as a survivor of modern slavery 3. Aged 18 years or over; within 5 years of giving birth. We will include a range of characteristics to support heterogeneity (various ages, nationalities, ethnicities, rural/urban areas) Professionals: 1. Maternity professionals (working clinically or strategically) and non-statutory service staff providing care and support to women survivors |
| Key exclusion criteria | Survivor mothers: Mothers who have no experience of any aspect of UK maternity care Professionals: Not meeting the inclusion criteria |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 16/06/2025 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The databases generated during and/or analysed during the current study are not expected to be made available due to confidentiality issues. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/08/2025: The date of final enrolment was changed from 31/05/2025 to 16/06/2025. Total final enrolment added. Completion date was changed from 30/09/2025 to 31/12/2025.
12/07/2024: Trial's existence confirmed by the University of Nottingham, Faculty of Medicine and Health Sciences Ethics Committee.
