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Neonatal outcomes in gestational diabetes trials: what clinicians should consider when interpreting treatment effects

Year: 2026

Type: article

Abstract: Determining whether treatment of gestational diabetes mellitus benefits the newborn is central to clinical guidelines and patient counseling. However, the conclusions drawn from major trials may depend not only on the biological effect of treatment, but also on the neonatal outcomes and birth weight standards selected. Composite endpoints can obscure or exaggerate treatment effects when they combine events that differ in clinical importance, frequency, or responsiveness to treatment. Similarly, different definitions of fetal overgrowth can substantially alter the reported prevalence of large- and small-for-gestational-age infants and therefore the apparent balance between treatment benefit and possible overtreatment. This review examines landmark and illustrative studies, including Australian Carbohydrate Intolerance Study in Pregnant Women, Maternal-Fetal Medicine Units Network, Hyperglycemia and Adverse Pregnancy Outcome, Treatment of Booking Gestational Diabetes Mellitus, Continuous Glucose Monitoring in the Management of Gestational Diabetes in Switzerland, Big Baby, and Real-time Continuous Glucose Monitoring for Reduced Adverse Complications and Events in Women With Gestational Diabetes, together with methodological literature on composite outcomes and birth weight classification. Across these studies, treatment effects were sometimes driven by a single frequent component, masked by biochemical or rare outcomes, or altered by the growth chart applied. Absolute birth weight thresholds are transparent but do not account for gestational age or infant sex, whereas percentile-based definitions provide adjustment but yield different results across Gestation Related Optimal Weight, International Fetal and Newborn Growth Consortium for the 21st Century, World Health Organization, and other standards. Clinicians and investigators should therefore assess neonatal benefit using clinically coherent outcomes reported individually, together with prespecified birth weight measures and potential treatment-related harm. Absolute birth weight thresholds and percentile-based measures, including both large- and small-for-gestational-age outcomes, should be reported together, with explicit specification of the growth chart and sensitivity analyses using alternative standards.

Source: American Journal of Obstetrics and Gynecology

DOI: 10.1016/j.ajog.2026.08.044