NCT03570632

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Maisa N. Feghali, MD · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Pregnancy in Diabetes

Interventions

Type	Name	Description
DRUG	Metformin	Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy

Timeline

• Start date: 2019-07-08
• Primary completion: 2025-10-30
• Completion: 2026-05-31
• First posted: 2018-06-27
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study