An Electronic Registry for Improving the Quality of Antenatal Care in Rural Bangladesh (eRegMat): Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND:Digital health interventions (DHIs) can alleviate several barriers to achieving better maternal and child health. The World Health Organization's guideline recommendations for DHIs emphasize the need to integrate multiple DHIs for maximizing impact. The complex health system of Bangladesh provides a unique setting for evaluating and understanding the role of an electronic registry (eRegistry) for antenatal care, with multiple integrated DHIs for strengthening the health system as well as improving the quality and utilization of the public health care system. OBJECTIVE:The aim of this study is to assess the effect of an eRegistry with DHIs compared with a simple digital data entry tool without DHIs in the community and frontline health facilities. METHODS:The eRegMat is a cluster-randomized controlled trial conducted in the Matlab North and Matlab South subdistricts in the Chandpur district, Bangladesh, where health facilities are currently using the eRegistry for digital tracking of the health status of pregnant women longitudinally. The intervention arm received 3 superimposed data-driven DHIs: health worker clinical decision support, health worker feedback dashboards with action items, and targeted client communication to pregnant women. The primary outcomes are appropriate screening as well as management of hypertension during pregnancy and timely antenatal care attendance. The secondary outcomes include morbidity and mortality in the perinatal period as well as timely first antenatal care visit; successful referrals for anemia, diabetes, or hypertension during pregnancy; and facility delivery. RESULTS:The eRegistry and DHIs were co-designed with end users between 2016 and 2018. The eRegistry was implemented in the study area in July 2018. Recruitment for the trial started in October 2018 and ended in June 2020, followed by an 8-month follow-up period to capture outcome data until February 2021. Trial results will be available for publication in June 2021. CONCLUSIONS:This trial allows the simultaneous assessment of multiple integrated DHIs for strengthening the health system and aims to provide evidence for its implementation. The study design and outcomes are geared toward informing the living review process of the guidelines for implementing DHIs. TRIAL REGISTRATION:ISRCTN Registry ISRCTN69491836; https://www.isrctn.com/ISRCTN69491836. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/26918.