Late Versus Early Management of Gestational Diabetes Mellitus: a Randomized Multicenter Trial Comparing Intensive Metabolic Treatment Starting Before 20 Weeks to Usual Care at 24-28 Weeks

What this Trial Is About

Researchers are investigating the timing of diagnosis and management of Gestational Diabetes Mellitus (GDM) in pregnant women, focusing on whether early intensive treatment starting before 20 weeks of pregnancy is better than the usual approach of waiting until 24 to 28 weeks. The study addresses concerns that early fasting plasma glucose testing may not accurately predict later GDM and examines if early intervention improves outcomes for mothers and babies. This is a randomized trial comparing two management strategies for early GDM, a condition characterized by high blood sugar during pregnancy. The trial compares two groups of pregnant women diagnosed with early GDM. One group receives intensive metabolic treatment immediately after diagnosis, including diet, physical activity, blood glucose monitoring, and possibly insulin therapy following French guidelines. The other group follows the standard approach with no intervention until GDM screening at 24 to 28 weeks, after which treatment begins if needed. The study continues treatment until delivery. Participants will be monitored throughout pregnancy with various metabolic tests, including fasting plasma glucose, HbA1c, and oral glucose tolerance tests. Researchers will track the frequency of maternal and fetal complications at delivery and assess insulin use, metabolic parameters, and neonatal outcomes up to six weeks postpartum. Additional analyses include studying microbiota and breast milk composition. The total participation period spans from early pregnancy until six weeks after delivery, with detailed data collected at multiple time points.

Early Gestational Diabetes Mellitus