Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

Withdrawn before enrolling · Phase 4

Conditions studied: Prediabetes; Complicating Pregnancy

In brief

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 metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

Key facts

Study ID

NCT04523363

Run by

Gianna Wilkie

People needed

0

Starts

2025-06-01

Expected to finish

2026-06-30

Last updated by the study team

2025-04-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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