eRegMat – a digital registry for improved quality of antenatal care: a cluster-randomized trial in a rural area in Bangladesh

Introduction Longitudinal client tracking systems with digital health interventions are recommended for implementation in resource-limited settings but lack evidence of benefits, harms, and implementation. In the eRegMat cluster-randomized controlled trial, we aimed to assess the effectiveness of an eRegistry versus an unshared digital client record. Methods Fifty-nine primary health care facilities in Matlab, Bangladesh were randomized with a 1:1 allocation ratio to receive an eRegistry (intervention, 30 health facilities) with decision support, feedback dashboards and targeted client communication, or an unshared digital client record without digital health interventions (control, 29 health facilities). We assessed timely antenatal care attendance, quality of care, and health outcomes. Outcome data were captured in the eRegistry, or unshared digital client record used by health workers, and through a postpartum household survey. We estimated adjusted relative risks (ARRs) following the intention-to-treat principle and adjusted for cluster randomization. Results From October 2018 to June 2020, 3023 pregnant women were enrolled in the intervention and 2746 in the control groups through community and facility registrations. Intervention and control groups did not differ for the primary outcomes: timely attendance at eligible antenatal care visits (42.5% vs. 40.3%, ARR 0.96, 95% CI 0.89–1.05, p -value 0.4) and hypertension screening and management (95.1% vs. 94.7%, ARR 1.00, 95% CI 0.96–1.03, p -value 0.8). The secondary outcome of perinatal mortality and severe perinatal morbidities was lower in the intervention (14.6%) compared to the control group (15%) (ARR 0.74, 95% CI 0.58–0.96, p -value 0.02), with the change mostly attributed to morbidity outcomes. Conclusion Due to technical and implementation challenges we were unable to estimate the effect of the intervention with sufficient precision. Challenges included delays in rollout of the digital health interventions and outcome data collection, existence of parallel documentation systems on paper and digital and the COVID-19 pandemic. Given these methodological constraints, we are unable to draw definitive interpretations of trial results. Trial registration ISRCTN Registry ISRCTN69491836; https://www.isrctn.com/ISRCTN69491836 . Date of registration 06.12.2018.