Cluster randomized controlled trial to assess the effectiveness of a package of community-based intervention on continuum of maternal and newborn healthcare in Sidama, Ethiopia:The SiMaNeH trial protocol

Abstract

AbstractBackgroundMaternal and newborn mortality and morbidity remain high in low-and middle-income countries such as Ethiopia. Limited access and dropouts from essential continuum of care interventions are critical factors. In Ethiopia about one in five complete the continuum of essential care through pregnancy, childbirth, and postnatal period Ethiopia. Evidence is limited on whether a package of interventions involving key community health actors increase the proportion completing essential maternal and newborn healthcare continuum in rural Sidama regional state, Ethiopia.ObjectiveThis study aims to implement and evaluate the effectiveness of community-based interventions designed to enhance involvement of key community health actors to improve completion rate of continuum of maternal care and utilization of newborn care.MethodsTwenty rural kebeles (clusters) in Sidama Regional State, Ethiopia, are randomly allocated to intervention and control arms. A total of 2000 pregnant women, 1000 per arm, will be recruited between 20thand 26thweek of gestation after intervention. Then they will be followed until six weeks postpartum between June 2024 and February 2025. In the intervention arm, mothers and newborns will receive targeted interventions at home and in their community through a package of interventions designed to improve completion rate of recommended maternal and newborn care. Control clusters will receive normal care from the state public health system. Primary outcomes will be the difference in the completion of continuum of maternal care and essential and emergency newborn care between intervention and control clusters measured by composite indicator constructed from variables. Secondary outcomes include rates of antenatal care completion, facility deliveries with skilled care, completion of at least four postnatal care, essential newborn care, and emergency identification and referrals, mortality measures.ConclusionThis trial will implement and evaluate community-based intervention package within existing community healthcare infrastructure to produce evidence for informed policy and practice to achieve improved community-based healthcare.