RecruitingNot ApplicableNCT05388643

Early Detection of Gestational Diabetes Mellitus in Pregnancy

Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial


Sponsor

University of Massachusetts, Worcester

Enrollment

80 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Enhanced First Trimester GDM Screening and Routine Gestational Diabetes Screening for people with gestational diabetes mellitus in pregnancy and pregnancy, high risk. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTEnhanced 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_TESTRoutine 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

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NCT05388643


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