A continuity of care programme for women at risk of preterm birth in the UK: Process evaluation of a hybrid randomised controlled pilot trial.

Background: The development and evaluation of specific maternity care packages designed to address preterm birth remains a public health priority. We aim to evaluate the implementation, context, and potential mechanisms of action, of a new care pathway that combined midwifery continuity of care with a specialist obstetric clinic for women at risk of preterm birth (POPPIE) in London (UK).

Methods: We did a multiphase mixed method triangulation evaluation nested within a hybrid type 2, randomised controlled trial in London (United Kingdom).

Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation-effectiveness, randomised controlled pilot trial in the UK.

Background: Midwifery continuity of care is the only health system intervention shown to reduce preterm birth (PTB) and improve perinatal survival, but no trial evidence exists for women with identified risk factors for PTB. We aimed to assess feasibility, fidelity, and clinical outcomes of a model of midwifery continuity of care linked with a specialist obstetric clinic for women considered at increased risk for PTB.

Methods And Findings: We conducted a hybrid implementation-effectiveness, randomised, controlled, unblinded, parallel-group pilot trial at an inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB were randomly assigned (1:1) to either midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women's Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas).