Early Detection of Gestational Diabetes Mellitus in Pregnancy

This study is looking at ways to find gestational diabetes mellitus (GDM) – a type of diabetes that can develop during pregnancy – earlier. Researchers want to see if an "Enhanced First Trimester GDM Screening" method works better than the usual "Routine Gestational Diabetes Screening." The enhanced screening involves early glucose (sugar) testing along with checking other factors and blood markers like triglycerides. The routine screening happens later in pregnancy, between 24 and 28 weeks. The study aims to enroll 80 pregnant women who are at high risk for GDM. Success will be measured by how well GDM is detected during pregnancy. The current recruitment status is unclear.

Study design: This is an interventional study that plans to enroll 80 high-risk pregnant women. Participants will be randomly assigned to either the enhanced early screening or the standard care group.
What's involved: Participants will undergo either early glucose screening with additional tests in the first trimester, or routine screening between 24 and 28 weeks of gestation.
Compensation: Not stated in the trial record.
Follow-up: Gestational Diabetes Mellitus will be measured during pregnancy (24-28 weeks gestation).

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Early Detection of Gestational Diabetes Mellitus in Pregnancy

Recruiting

NAAges 18+InterventionalScreening

University of Massachusetts, Worcester

~80 participants

Updated 2026-04-06 on ClinicalTrials.gov

What's tested:Enhanced First Trimester GDM ScreeningRoutine Gestational Diabetes Screening

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Gestational Diabetes Mellitus

Measured over In pregnancy (24-28 weeks gestation)

Conditions

Gestational Diabetes Mellitus in Pregnancy

Pregnancy, High Risk

Where it's being run

1 sites across 1 states

Massachusetts1

Study leadership

Gianna Wilkie, MD · PRINCIPAL_INVESTIGATOR · University of Massachusetts, Worcester

Who to contact

Gianna L Wilkie, MD

[email protected]

77743642523

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Gestational Diabetes MellitusIn pregnancy (24-28 weeks gestation)
Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test

Trialytics