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Early Detection of Gestational Diabetes Mellitus in Pregnancy

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

Who can join

Ages 18 and older · Women

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.

About the study

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).

What is being tested

• Enhanced First Trimester GDM Screening (diagnostic test)
• Routine Gestational Diabetes Screening (diagnostic test)

Sponsor: University of Massachusetts, Worcester · Participants: 80 · Started: Jul 1, 2025

Contact the study team

• Gianna L Wilkie, MD · Phone: 77743642523

Official record on ClinicalTrials.gov — NCT05388643

Locations in the U.S.

Conditions

• Gestational Diabetes

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.