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Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes
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.
Conditions:
🦠 Prediabetes; Complicating Pregnancy
🗓️ Study Start (Actual) 1 June 2025
🗓️ Primary Completion (Estimated) 30 June 2026
✅ Study Completion (Estimated) 30 June 2026
👥 Enrollment (Estimated) 240
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Worcester, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 August 2020
  • First Submitted that Met QC Criteria 20 August 2020
  • First Posted 21 August 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 April 2024
  • Last Update Posted 9 April 2024
  • Last Verified April 2024
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