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 .
Oakley et al. (Wed,) studied this question.