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Clinical Trial Summary

Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03570632
Study type Interventional
Source University of Pittsburgh
Contact Maisa N Feghali, MD
Phone 4126471000
Email feghalim@upmc.edu
Status Recruiting
Phase Phase 4
Start date July 8, 2019
Completion date December 2024

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