Does the midwife-led continuity of carer model improve birth outcomes and maternal mental health in vulnerable women?
- Conditions
- Prevention of negative birth outcomes and poor perinatal mental health in vulnerable pregnant women.Pregnancy and Childbirth
- Registration Number
- ISRCTN31836167
- Lead Sponsor
- Bradford Teaching Hospitals NHS Foundation Trust
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37996235/ (added 24/11/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 663
Current inclusion criteria as of 28/02/2023:
Effectiveness Evaluation
1. Have been randomised to receive intervention or control care
2. Have consented to take part in Born in Bradford (BiB) cohort studies: BiBBS (Born in Bradford Better Start) study or BiB4All (Born in Bradford for all) cohort study
Process Evaluation
1. Have received the MCC model of care
2. Had a live birth a minimum of 4 weeks and a maximum of 20 weeks before the time of recruitment
3. Have completed a ‘consent to contact’ form (to confirm the research team can get in touch with them)
4. Have given informed consent to participate in a qualitative interview
5. Speak a language accessible to the research team
Previous inclusion criteria:
Randomisation for MCC care
1. Be referred or make a self-referral to the BTHFT Women’s and Newborn Unit for pregnancy care, between the 1st April 2022 and the 31st March 2024.
2. Reside in the BSB area or be registered with a general medical practice (GP) associated with the RIC programme, and within the geographical remit of the standard care teams forming the eligible population for the trial.
And:
3. Be less than 29 weeks gestation at the time of referral for maternity care.
4. Have no requirement for a referral to a specialist midwifery team or consultant care.
Effectiveness Evaluation
1. Have been randomised to receive intervention or control care
2. Have consented to take part in Born in Bradford (BiB) cohort studies: BiBBS (Born in Bradford Better Start) study or BiB4All (Born in Bradford for all) cohort study
Process Evaluation
1. Been randomised to receive MCC model of care
2. Had a live birth a minimum of 4 weeks and a maximum of 20 weeks before the time of recruitment
3. Have completed a ‘consent to contact’ form (to confirm the research team can get in touch with them)
4. Have given informed consent to participate in a qualitative interview
Effectiveness evaluation
1. Have pregnancy loss or termination (<24 weeks gestation)
2. Have not registered their pregnancy <29 weeks gestation
3. Move outside of the geographical remit of the care teams following randomisation
4. Withdraw consent for data linkage via the BiB4All/BiBBS cohorts before the end of the evaluation period
Process Evaluation
1. Have pregnancy loss
2. Have a stillbirth/infant death
3. Their child is still receiving care/treatment in hospital
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method