Conclusion
PRETERM BIRTH
To our knowledge, POPPIE is the first hybrid type 2 pilot trial of a model of midwifery continuity of care for women at risk of preterm birth London (UK) that has evaluated core implementation and processes outcomes, using a mixed-methods approach, and integrating these with the primary outcome in order to understand the findings in our context. We have demonstrated that, overall, the POPPIE model of care was appropriate, feasible and implemented with high fidelity; was acceptable among women and HCPs; and was embedded, adapted, and sustained in maternity services. As expected for a pilot study focused on feasibility of a larger trial and with limited statistical power, there were no differences in the primary outcome and there was no association between implementation outcomes and the primary outcome. Larger appropriately powered trials considering primary outcomes such as preterm birth are feasible and needed, including in community settings, to evaluate the impact and implementation of continuity models in other populations such as women with social disadvantage and vulnerability.