Recruiting

Gestational Diabetes

Sponsor:

University of Massachusetts, Worcester

Code:

NCT05388643

Conditions

Gestational Diabetes Mellitus in Pregnancy

Pregnancy, High Risk

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced First Trimester GDM Screening

Routine Gestational Diabetes Screening

Study Details

Brief 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).

Conditions

Gestational Diabetes Mellitus in Pregnancy

Pregnancy, High Risk

Study ID

NCT05388643

Start date

Jul 1, 2025

Status verified date

Mar, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1\) age greater than or equal to 18 years old,
  • 2\) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
  • 3\) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
  • 4\) able and willing to provide informed consent,
  • 5\) English or Spanish speaking, and
  • 6\) are at high risk for developing GDM by ACOG clinical risk factor guidelines.

Exclusion Criteria:

  • 1\) known diagnosis of pre-existing pregestational diabetes,
  • 2\) plan to receive prenatal care or deliver outside of UMMHC,
  • 3\) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
  • 4\) systemic steroid use.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Gianna L Wilkie, MD

77743642523Gianna.Wilkie@umassmemorial.org

Locations

University of Massachusetts Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Gianna L Wilkie, MD

508-334-4067Gianna.Wilkie@umassmemorial.org

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Keywords

  • Pregnancy
  • Gestational Diabetes
  • Screening
  • Maternal Outcomes
  • Neonatal Outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-04-06.