Status:
WITHDRAWN
Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes
Lead Sponsor:
Gianna Wilkie
Conditions:
Prediabetes; Complicating Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metfo...
Detailed Description
Women in pregnancy are routinely screened for diabetes in the first trimester and those who fall into the prediabetes category by hemoglobin A1c level of 5.7 to 6.4%, fasting plasma glucose of greater...
Eligibility Criteria
Inclusion
- Pregnant women with hemoglobin A1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation
- Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
- Patients able to provide written informed consent
Exclusion
- Pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above
- Presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin
- Participants who are under the age of 18
- Multiple Pregnancy
- Patients already taking metformin for other indications
- Fetal defect noted on early dating ultrasound
- Miscarriage before randomization
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04523363
Start Date
June 1 2025
End Date
June 30 2026
Last Update
April 11 2025
Active Locations (1)
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1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605