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NCT Number: NCT03570632

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Pregnancy in Diabetes Pregnancy in Diabetics Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

metformin

Drug

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

Primary outcomes

  1. Rate of hypertensive disorders of pregnancy

    Time frame: Delivery/End of pregnancy

Secondary outcomes

  1. Home glucose levels throughout pregnancy

    Time frame: Weekly, throughout pregnancy from enrollment to delivery

  2. Birthweight

    Time frame: Delivery/End of pregnancy

  3. Neonatal morbidity

    Time frame: Delivery/End of pregnancy

Other outcomes

  1. Gestational weight gain

    Time frame: At time of prenatal visits, throughout pregnancy from enrollment to delivery

  2. Umbilical cord c-peptide

    Time frame: Delivery/End of pregnancy

  3. Umbilical cord glucose

    Time frame: Delivery/End of pregnancy

  4. Neonatal body composition

    Time frame: Delivery/End of pregnancy

Sponsors and collaborators

Lead sponsor

Maisa N. Feghali, MD

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Jun 27, 2018
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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