Educational films for gestational diabetes do not reduce adverse perinatal outcomes in Uganda and India 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 healthcare providers to improve timely detection and management of GDM could reduce the incidence of adverse perinatal outcomes. 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. 30 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 (PRs). Data analysts were blinded to group allocation, but participants, facility and trial staff were not. 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 10 899 (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 (PR 1.00, 95% CI 0.87 to 1.14). For India, the prevalence was 29.5% and 30.6%, respectively (PR 1.04, 95% CI 0.96 to 1.11). The pooled PR across both countries was 1.03 (95% CI 0.97 to 1.10). 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. TRIAL REGISTRATION NUMBERS: NCT03937050, ISRCTN96432637.