Early Detection of Gestational Diabetes Mellitus in Pregnancy

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 18, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

Conditions
Gestational Diabetes Mellitus in PregnancyPregnancy, High Risk
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Trial Locations (1)

01605

RECRUITING

University of Massachusetts Memorial Medical Center, Worcester

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Massachusetts, Worcester

OTHER

NCT05388643 - Early Detection of Gestational Diabetes Mellitus in Pregnancy | Biotech Hunter | Biotech Hunter