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ACTIVE NOT RECRUITING
NCT03570632
PHASE4

Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus

Sponsor: Maisa N. Feghali, MD

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2019-07-08

Completion Date

2026-05-31

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DRUG

Metformin

Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy

Locations (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States