Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis

Introduction Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population. Methods and analysis An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024. Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process. Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734). Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives' and women's perspectives. Ethics and dissemination Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings. Trial registration number IsRCTNhttps://doi.org/10.1186/ISRCTN31836167