NCT05388643 Early Detection of Gestational Diabetes Mellitus in Pregnancy
| NCT ID | NCT05388643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Massachusetts, Worcester |
| Condition | Gestational Diabetes Mellitus in Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Gianna Wilkie, MD
PRINCIPAL INVESTIGATOR
University of Massachusetts, Worcester
Frequently Asked Questions
Who can join the NCT05388643 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Diabetes Mellitus in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05388643 currently recruiting?
Yes, NCT05388643 is actively recruiting participants. Contact the research team at Gianna.Wilkie@umassmemorial.org for enrollment information.
Where is the NCT05388643 trial being conducted?
This trial is being conducted at Worcester, United States.
Who is sponsoring the NCT05388643 clinical trial?
NCT05388643 is sponsored by University of Massachusetts, Worcester. The principal investigator is Gianna Wilkie, MD at University of Massachusetts, Worcester. The trial plans to enroll 80 participants.
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