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Clinical trial

Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening and Treatment

ID
Name
STUDY00001870
Description
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment with metformin for postpartum patients with pregnancies affected by GDM.
Trial arms
Trial start
2025-04-01
Estimated PCD
2028-04-01
Trial end
2028-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Metformin Hydrochloride
metformin extended-release formulation (500 mg tablet administered orally daily with evening meal)
Arms:
Metformin Treatment Postpartum
Other names:
metformin, glucophage
Active Comparator
Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.
Arms:
Standard of Care Education
Size
80
Primary endpoint
Glycemic Outcomes--Hemoglobin A1c
3 months, 6 months and 1 year
Glycemic Outcomes--Fructosamine Levels
3 months, 6 months and 1 year
Eligibility criteria
Inclusion Criteria: * pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria * receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial * able and willing to provide informed consent * English or Spanish speaking * ability to complete immediate in hospital postpartum glucose testing * have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL Exclusion Criteria: * known diagnosis of pre-existing pre-gestational diabetes in pregnancy * inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum * systemic steroid use
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-06-13

1 organization

1 drug

2 indications

Organization
University of Massachusetts, Worcester
Drug
Metformin
Indication
Gestational Diabetes
Indication
Type 2 Diabetes