Site-randomised trial of a multilevel digital intervention to reduce maternal morbidity and mortality: a study protocol.

INTRODUCTION

Compared with other high-income countries, the USA continues to have the highest rates of pregnancy-related and associated mortality and morbidity (PRAMM), particularly in rural areas and among non-Hispanic black pregnancies. Over 80% of pregnancy-related deaths are preventable; however, the intensity of existing interventions has proven difficult to broadly disseminate. Technology offers the potential to address such barriers. This study will develop a multilevel digital intervention to reduce PRAMM and evaluate its effects using a site-randomised trial.

METHODS AND ANALYSIS: The Michigan Healthy Mom (MI MOM) intervention will be developed using a community-partnered approach and will seek to address PRAMM risks at four distinct levels: individual, support system, provider and community. Pregnant participants and up to three members of their personal support system will receive an initial brief interactive session through a mobile web app and will thereafter receive a series of text messages with links to extended content. Healthcare providers will receive biweekly text messages and/or flyers distributed in clinic staff areas, and community health workers-who can facilitate access to local services-will be available via secure live chat text access. MI MOM effects will be evaluated using a cluster-randomised trial in 10 antenatal care clinics throughout Michigan (N=500 pregnant participants aged 18+ years receiving Medicaid). We will compare intervention and control arms on two coprimary outcomes: total PRAMM through 1 year post partum as measured using a universally collected linked dataset of Medicaid claims and vital records and an index of PRAMM risk factors directly targeted by MI MOM.

ETHICS AND DISSEMINATION: The Michigan State University Institutional Review Board has provided ethical approval (STUDY00011005). Results will be disseminated via presentations at academic conferences and community forums, as well as publications in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: NCT07213284.