Effectiveness of Checklist based Box system Interventions (CBBSI) versus routine care on improving utilization of Maternal Health Service in North West, Ethiopia: Study protocol for a Cluster Randomized Controlled Trial

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Abstract Background-Maternal mortality is still high in Ethiopia. Antenatal care, use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in low and middle-income countries including Ethiopia, utilization of these key services is limited, so that preventive, promotive and curative services are not provided as per the recommendation. The aim of this study is to examine the effectiveness of checklist based box system interventions on improving maternal health service utilization. Methods - A community level cluster-randomized controlled trial will be conducted to compare the effectiveness of checklist based box system interventions over the routine standard of care, as a control arm. The intervention will use health extension program and provided by health extension workers and midwives, using a special type of health education scheduling and service utilization monitoring boxes, placed at health posts and health centers respectively. For this, 1,200 pregnant mothers, below 16 weeks of gestation, will be recruited from 30 clusters. Suspected pregnant mothers will be identified through a community survey and linked to the nearby health center. With effective communication between health centers and health posts, dropout-tracing mechanisms are implemented to make mothers resume service utilization. Data will be collected using ODK-Collect and analyzed using STATA version 13.0. Data will be analyzed by intention to treat analysis. Risk ratio will be computed at cluster level and the summary will be compared using t-test. Outcomes between intervention and control groups will be compared with random effects logistic regression models. Achieving four antenatal care, health facility delivery and postnatal care visits at 6 weeks of delivery were treated as primary out comes for this study. Discussion - The authors of this study expect that, the study will generate evidence on the effectiveness of checklist based box system interventions on improving utilization of maternal health care service, that produce inputs for related policies in the country. Trial Registration – ClinicalTrials.gov NCT03891030, 26 March 2019, Retrospectively Registered Keywords - Box system, maternal health, Antenatal care, skilled delivery, postnatal care, cluster randomized controlled trial, Ethiopia

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