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RECRUITING
NCT05388643
NA

Early Detection of Gestational Diabetes Mellitus in Pregnancy

Sponsor: University of Massachusetts, Worcester

View on ClinicalTrials.gov

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

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.

Locations (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States