Early Detection of Gestational Diabetes Mellitus in Pregnancy
Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
University of Massachusetts, Worcester
80 participants
Jul 1, 2025
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
Inclusion Criteria6
- \) age greater than or equal to 18 years old,
- \) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
- \) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
- \) able and willing to provide informed consent,
- \) English or Spanish speaking, and
- \) are at high risk for developing GDM by ACOG clinical risk factor guidelines.
Exclusion Criteria4
- \) known diagnosis of pre-existing pregestational diabetes,
- \) plan to receive prenatal care or deliver outside of UMMHC,
- \) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
- \) systemic steroid use.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05388643