Educational films for improving perinatal outcomes associated with gestational diabetes in Uganda and India:a cluster randomised trial

Introduction: Gestational diabetes mellitus (GDM) is associated with a high risk of adverse perinatal outcomes. We evaluated whether a film-based educational intervention for pregnant women and health care providers to improve timely detection and management of GDM could reduce the incidence of adverse perinatal outcomes.<br/><br/>Methods: Two parallel-group cluster randomised trials were conducted in Uganda and India. A package of 7 interconnected culturally-tailored educational films was developed following formative research. Thirty government-funded health facilities (clusters) in each country were randomised (1:1) to intervention or control arm. In intervention facilities (15 in each country), films were shared with pregnant women and health professionals; control facilities (15 in each country) received usual care. The outcome was an individual self-reported composite of unplanned caesarean section, stillbirth or neonatal death, or neonatal hospitalisation. Mixed effects models were used in an intention-to-treat analysis with multiple imputation by chained equations to address missing data. Analyses were performed separately for each country; random-effects meta-analysis was used to calculate pooled prevalence ratios. Data analysts were blinded to group allocation, but participants, facility, and trial staff were not.<br/><br/>Results: In Uganda, 5495 women were screened between May 2021 and April 2022, and 5102 (92.8%) participated in the trial. In India, 12,045 women were screened between July 2021 and January 2022, and 10899 (90.5%) participated. Loss to follow-up was 31.7% in Uganda and 12.1% in India. In Uganda, the prevalence of the composite adverse perinatal outcome was 19.7% in the control arm and 19.8% in the intervention arm (prevalence ratio (PR) 1.00, 95% CI 0.87-1.14). For India, the prevalence was 29.5% and 30.6% respectively (PR 1.04, 95% CI 0.96-1.11). The pooled PR across both countries was 1.03 (95% CI 0.97-1.10).<br/><br/>Conclusions: A film-based intervention did not reduce the incidence of adverse perinatal outcomes associated with GDM. Future evaluations should assess educational films delivered alongside more intensive intervention components.<br/>