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

Maisa N. Feghali, MD (Other)
Overall Status
Recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Anticipated Enrollment :
60 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Actual Study Start Date :
Jul 8, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Usual care

Experimental: Metformin

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

Outcome Measures

Primary Outcome Measures

  1. Rate of hypertensive disorders of pregnancy [Delivery/End of pregnancy]

Secondary Outcome Measures

  1. Home glucose levels throughout pregnancy [Weekly, throughout pregnancy from enrollment to delivery]

  2. Birthweight [Delivery/End of pregnancy]

  3. Neonatal morbidity [Delivery/End of pregnancy]

Other Outcome Measures

  1. Gestational weight gain [At time of prenatal visits, throughout pregnancy from enrollment to delivery]

  2. Umbilical cord c-peptide [Delivery/End of pregnancy]

  3. Umbilical cord glucose [Delivery/End of pregnancy]

  4. Neonatal body composition [Delivery/End of pregnancy]

Eligibility Criteria


Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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).

Contacts and Locations


Site City State Country Postal Code
1 Magee Womens Hospital of UPMC Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • Maisa N. Feghali, MD


  • Principal Investigator: Maisa N Feghali, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Maisa N. Feghali, MD, Assistant Professor, University of Pittsburgh Identifier:
Other Study ID Numbers:
  • PRO18050459
First Posted:
Jun 27, 2018
Last Update Posted:
Dec 6, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2021