Prevention of negative birth outcomes and poor perinatal mental health in vulnerable pregnant women. Pregnancy and Childbirth
Conditions
Interventions
The MCC model of care provides women with a full continuity of carer service throughout the antenatal, intrapartum and postnatal periods, delivered by a named midwife and support team. Compared to sta
Sponsors
Bradford Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 28/02/2023: 1. Spontaneous vaginal delivery indicated at birth, measured using data obtained via the linked routine health (maternity) record for cohort participants 2. Maternal depression measured using the PHQ-8 assessment tool at 6-10 weeks postnatal Previous primary outcome measures: Internal Pilot: 1. Number of women randomised relative to the total number eligible using data obtained from the maternity service and cumulative trial monitoring data at 3 months 2. Allocation ratio measured using cumulative trial monitoring data at 3 months Effectiveness Evaluation: Primary outcome measures: Parent 1. Spontaneous vaginal delivery indicated at birth, measured using data obtained via the linked routine health (maternity) record for cohort participants 2. Mental ill health measured using the PHQ-8 and GAD-7 assessment tools at 6-10 weeks postnatal Process Evaluation: Midwifery teams: 1. Number of reflective diaries completed by MCC midwives (maximum 2 per individual) and team leaders (maximum 4 per individual) using research team study records on 31/03/2024 2. Detail of the challenges and barriers staff within the MCC midwifery team faced when providing this model of care, obtained qualitatively (i.e., free text) through the study-specific reflective diaries completed either twice (for midwives) or 4 times (for team leaders) per year Women: 1. Number of interviews completed by women who received MCC care during (at least) the antenatal and postnatal periods assessed using research team study records on 31/03/2024 2. Pregnancy, birth and postnatal experiences of women who received MCC care assessed using qualitative interviews. A study-specific topic guide will explore the thoughts and experiences of women who received MCC care at different stages of their pregnancy journey; these will take place between 4-20 weeks post-birth Economic Evaluation: 1. Health-related quality of life at 1 year postnatal, measured using data ob | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 28/02/2023: Effectiveness Evaluation Secondary outcome measures: Parent 1. Emergency caesarean birth indicated at birth, using data obtained via the linked routine health (maternity) record for cohort participants 2. Breastfeeding initiation (first feed) indicated within the first 24 hours after birth, using early postnatal data obtained via the linked routine health (maternity) record for cohort participants 3. Identification of poor perinatal mental health while receiving midwifery care by a member of the maternity service. This will be measured using data obtained from the linked routine health (maternity) record for cohort participants; information captured at any point between referral and discharge will be included in analyses. Coded data will be examined for indication of poor mental health, with reference to predetermined code lists. 4. Experience of poor mental health in the first 12 months following birth, identified via routine data linkage of the health visiting and GP records of cohort participants. Coded data will be examined for indication of poor mental health, with reference to predetermined code lists. 5. Parent-child relationship assessed using the Mothers Object Relations Scale (MORS) at 6-10 weeks postnatal 6. Maternal anxiety measured using the GAD-7 assessment tools at 6-10 weeks postnatal Secondary outcome measure: Child 1. Low birth weight (<2500 g; any gestational age) indicated at birth using data obtained via the linked routine health (maternity) record for cohort participants Previous secondary outcome measures: Effectiveness Evaluation Secondary outcome measures: Parent 1. Emergency caesarean birth indicated at birth, using data obtained via the linked routine health (maternity) record for cohort participants 2. Breastfeeding initiation (first feed) indicated within the first 24 hours after birth, using early postnatal data obtained via the linked routine health (maternity) record for cohort | — |
Countries
England, United Kingdom
Outcome results
None listed