WithdrawnPhase 4

Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

Stopped: Study was not funded and could not be performed

United States0Started 2025-06-01

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

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Birth Weight

Timeframe: At Birth

Trial details

NCT IDNCT04523363

SponsorGianna Wilkie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Prediabetes; Complicating Pregnancy trials