He Korowai Manaaki (Pregnancy Wraparound Care): Study Protocol for a Cluster Randomised Clinical Trial (Preprint)

Background: Maternal and infant health inequities between Māori (the Indigenous peoples of Aotearoa New Zealand) and New Zealand European women are well documented and cannot be explained solely by socioeconomic status. A research center-iwi (tribal group) partnership aims to address these disparities and improve maternal and infant health outcomes by implementing an augmented maternity care pathway (He Korowai Manaaki) to improve access to services and evidence-informed care. Objective: The objective of this study is to test whether an augmented maternity care pathway improves Māori infant health outcomes. Methods: This is a Kaupapa Māori (by, with, and for Māori) cluster randomized clinical trial involving 8 primary care practices allocated to either an intervention arm or control arm. The intervention arm comprises an augmented maternity care pathway (He Korowai Manaaki) offering clinical care through additional paid health care appointments and improved access to social support (eg, housing, transport). The control arm is usual care. The primary outcome is increased timely vaccination for Māori infants, defined as all age-appropriate vaccinations completed by 6 months of age. Results: Recruitment commenced in November 2018 and was completed in June 2020, with 251 enrolled women recruited in intervention primary care practices before 20 weeks of pregnancy. Publication of results is anticipated in late 2023. Conclusions: The results will inform primary health care policy including whether the provision of augmented maternal care pathways reduces disparities in the structural determinants of health. If effective, He Korowai Manaaki will strengthen the health and well-being of pregnant Māori women and their babies and improve their health outcomes, laying a strong foundation for lifelong health and well-being. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001155189; https://tinyurl.com/yypbef8q