ISRCTN31836167进行中（未招募）未知
Effectiveness of a midwife-led continuity of carer model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot and process and economic evaluations.
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 663
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37996235/ (added 24/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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.
- •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
排除标准
- •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
研究者
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