Metformin for Prediabetes in Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Gianna L Wilkie, MD
Principal Investigator
UMass Memorial Health
Are You a Good Fit for This Trial?
This trial is for pregnant women receiving care at UMass Memorial Medical Center, who have prediabetes indicated by specific blood sugar tests before the 14th week of gestation. They must be able to consent in writing. It's not for those under 18, with pre-existing diabetes, on metformin already, or if they have liver/renal/heart failure, sensitivity to metformin, a multiple pregnancy or noted fetal defects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either metformin or standard prenatal care from 14 weeks of pregnancy until delivery
Follow-up
Participants are monitored for obstetric, maternal, and neonatal outcomes until the 6-week postpartum visit
What Are the Treatments Tested in This Trial?
Interventions
- Metformin
Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gianna Wilkie
Lead Sponsor