Status:
RECRUITING
Early Detection of Gestational Diabetes Mellitus in Pregnancy
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Pregnancy, High Risk
Eligibility:
FEMALE
18+ years
Phase:
NA
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 me...
Detailed Description
Gestational diabetes mellitus (GDM) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. GDM has lifelong complications including an increased risk of develo...
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.
Key Trial Info
Start Date :
August 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05388643
Start Date
August 18 2025
End Date
December 1 2026
Last Update
August 26 2025
Active Locations (1)
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1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605