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

Last updated: January 8, 2025
Sponsor: Maisa N. Feghali, MD
Overall Status: Active - Not Recruiting

Phase

4

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Prevention

Treatment

Metformin

Clinical Study ID

NCT03570632
STUDY19060327
  • Ages 18-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Known allergy or adverse reaction to metformin

  • Multiple gestation

  • Abnormal obstetrical ultrasound suspicious for major congenital abnormality, knownor 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, persistentlyabnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's andUlcerative colitis), major hematologic disorder (including alloimmune and isoimmunethrombocytopenia).

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Metformin
Phase: 4
Study Start date:
July 08, 2019
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Magee Womens Hospital of UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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