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

NCT ID: NCT03570632

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2026-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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

Interventions

Metformin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pregnant women 18-50 years
• 12 0/7 and 19 6/7 weeks of gestation
• Diagnosed with type 1 DM prior to pregnancy.

Exclusion Criteria

• Known allergy or adverse reaction to metformin
• Multiple gestation
• Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy
• Medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine > 1.1 mg/dL), proteinuria (P:C >0.3 or 24-hour urine protein > 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maisa N. Feghali, MD

OTHER

Sponsor Role: lead

Responsible Party

Maisa N. Feghali, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maisa N Feghali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19060327

Identifier Type: -

Identifier Source: org_study_id