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Early Detection of Gestational Diabetes Mellitus in Pregnancy
Sponsor: University of Massachusetts, Worcester
Summary
The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).
Official title: Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-07-01
Completion Date
2026-12-01
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
Enhanced First Trimester GDM Screening
Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment.
Routine Gestational Diabetes Screening
Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice.
Locations (1)
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States