Condition: Gestational Diabetes Mellitus · Pregnancy, High Risk · Sponsor: Ohio State University
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.
This description comes directly from the study's public registry record.
Kartik Venkatesh, MD, PhD · 614-293-2222 · kartik.venkatesh@osumc.edu
Anna Bartholomew, MPH, BS, RN · 614-685-3229 · Anna.Bartholomew@osumc.edu
Always discuss trial participation with your own doctor first.
| University of Alabama | Tuscaloosa, Alabama, United States | Recruiting |
| Cedars Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| University of California San Francisco | San Francisco, California, United States | Recruiting |
| Christiana Care | Newark, Delaware, United States | Withdrawn |
| University of South Florida | Tampa, Florida, United States | Recruiting |
| Tufts University | Boston, Massachusetts, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States | Terminated |
| Washington University in St. Louis | St Louis, Missouri, United States | Recruiting |
| University of New Mexico | Albuquerque, New Mexico, United States | Recruiting |
| Columbia University Irving Medical Center | New York, New York, United States | Recruiting |
| University of North Caroline | Chapel Hill, North Carolina, United States | Withdrawn |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06445946