A Pragmatic, Randomized Clinical Trial of Gestational Diabetes Screening
Abstract
This pragmatic, randomized clinical trial compared two screening approaches for gestational diabetes mellitus (GDM): the one-step method (75-g oral glucose tolerance test) and the two step method (50g glucose challenge test followed by a 100g oral glucose tolerance test if positive). The study involved 23,792 pregnant women across two health systems. Results showed that the one-step approach diagnosed GDM in 16.5% of women, nearly double the rate of the two step approach (8.5%). However, there were no significant differences in primary outcomes, including large-for-gestational-age infants (8.9% vs. 9.2%), perinatal composite outcomes (3.1% vs. 3.0%), gestational hypertension or preeclampsia (13.6% vs. 13.5%), or primary cesarean section (24.0% vs. 24.6%). Adherence was lower for the one step method (66%) compared to the two step method (92%). The findings suggest that while the one step approach identifies more cases of GDM, it does not improve maternal or perinatal outcomes. The study highlights the need for further research to determine the clinical benefits of diagnosing milder GDM cases.