Early Detection of Gestational Diabetes Mellitus in Pregnancy

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT05388643
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Diabetes Mellitus in Pregnancy
  • Pregnancy, High Risk

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enhanced First Trimester GDM Screening — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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.

Study Details

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).

Key Dates

Start date
Jul 1, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: 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.
  • Active Comparator: Standard of Care GDM 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.

Primary Outcome Measure

Gestational Diabetes Mellitus [ Time Frame: In pregnancy (24-28 weeks gestation) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Massachusetts Memorial Medical CenterWorcesterMassachusetts01605
Gianna L Wilkie, MD
[email protected]
508-334-4067

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By research site
University of Massachusetts Memorial Medical Center· Worcester, MA

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