Testing Early First Trimester Screening for Gestational Diabetes in High-Risk Pregnant Women

What this Trial Is About

Gestational diabetes mellitus GDM is a common condition during pregnancy that can lead to serious health issues for both mothers and their babies. This trial aims to develop and test a protocol for early first trimester screening to detect GDM sooner than the standard practice. The study will compare early screening methods to the usual screening performed later in pregnancy to see which approach is more feasible and acceptable for patients. Participants will be randomly assigned to one of two groups. One group will receive early glucose screening before 12 weeks using a prediction model that includes clinical risk factors and serum biomarkers like triglycerides, PAPP-A, and lipocalin-2. The other group will follow the standard screening care, which occurs between 24 to 28 weeks of pregnancy and may include fasting glucose, oral glucose tolerance test, or hemoglobin A1c based on provider choice. Women will take part during their pregnancy with assessments including blood tests for GDM detection at the designated times. Researchers will monitor outcomes such as GDM diagnosis during 24-28 weeks, mode of delivery, newborn birth weight, birth complications, APGAR scores, and neonatal intensive care admissions. Patient satisfaction with the screening method will also be evaluated after birth. The study spans from the first trimester through delivery and postpartum assessments.

Early Detection of Gestational Diabetes Mellitus in Pregnancy