Strengths and limitations
Strengths of our study include the randomized controlled trial design, comparison of the integrated MCH handbook against existing stand-alone home-based records, the rigorous trial design wherein we ensured the participant cohort had similar maternal characteristics, a low attrition rate and controlling for clustering at the municipality level in the analysis. Additionally, the MCH handbook intervention study was a population-based locally driven study done in a real-world and resource constrained setting demonstrating the practicability of the intervention.However, it also had some limitations. First, despite the rigorous design, the study was inadequately powered. Second, as a pragmatic open-label trial, women may have actively sought maternity care in municipalities providing the MCH handbook. Similarly, we could not avoid health care provider contamination resulting from personnel postings and transfer between municipalities. The extent to which women and health care providers migrated between clusters could not be established, and if this contributed to limiting intervention impact is unclear. Incorporating some elements of the intervention package to the control group could not be fully excluded which may have led to performance bias. Other administrative barriers may have limited maternal and child health care service availability, especially in rural areas and these limitations could have affected the trial endpoint independent of the intervention package. Third, the impact of the COVID-19 pandemic on provision of MNCH services and maternal health behavior could not be established. Although the collection of follow-up data was delayed, we kept the primary outcome unchanged to account for intervention effects prior to the pandemic. Fourth, integrating the trial with routine maternity care services may have required health care providers to divert time from routine activities to complete trial related steps, which could have negatively affected implementation of the intervention package and health care service delivery. Furthermore, provision of the new service could have stretched health care provider capacity, leading to longer waiting times and hindering access for women who had to travel far to reach health facilities.