Does the midwife-led continuity of carer model improve birth outcomes and maternal mental health in vulnerable women?

INTERVENTION: 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 standard care, MCC midwives are given smaller caseloads, can offer longer appointment times and prioritise discussion surrounding public health messages. Point‐of‐care randomisation with minimisation and multiple stratification variables will be employed. Women will be randomised by administration staff in the MCC teams. Random allocation to either the control (standard care) or intervention arm (MCC) will be completed before patients are contacted by the care provider. Eligible women will be randomised at the point of referral to the maternity service to receive either the MCC (midwife‐led continuity of care) intervention or to receive standard community midwifery care (SC). Those who are randomised to receive MCC will experience a relationship‐based, continuity of carer approach where a single midwife plans and provides care for a woman throughout the antenatal, intrapartum and postnatal stages. MCC midwives are responsible for smaller caseloads (maximum of 35 women per full‐time equivalent midwife) or more (depending on staffing pressures in SC) and therefore, can offer a personalised care service, with longer appointment times and tailored discussion surrounding public health messages. Women receiving MCC care will receive this type of care if they are less than 29 weeks gestation at the time of referral for maternity care, up until postnatal discharge from the service (the timing of which may be different for each woman), when their MCC midwife transfers their care to their health visitor (via their GP). SC aims to provide team‐based antenatal care though women may be CONDITION: Prevention of negative birth outcomes and poor perinatal mental health in vulnerable pregnant women. ; Pregnancy and Childbirth SECONDARY OUTCOME: 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; ; 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 PRIMARY OUTCOME: 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 obtained from the linked routine health record for cohort participants. Information captured at any point between referral to maternity and up to one year following birth will be included in analyses; 2. Health‐related resource use at 1 year postnatal, measured using data obtained from the linked routine health record for cohort participants. Information captured at any point between referral to maternity and up to one year following birth will be included in analyses 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