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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570632
• Other study ID #: PRO18050459
• Status: Recruiting
• Phase: Phase 4
• Start date: July 8, 2019
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: Maisa N Feghali, MD
• Phone: 4126471000
• Email: feghalim[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Pre-Eclampsia
• Pregnancy in Diabetes
• Pregnancy in Diabetics

Intervention

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

Locations

Country	Name	City	State
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Maisa N. Feghali, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gestational weight gain		At time of prenatal visits, throughout pregnancy from enrollment to delivery
Other	Umbilical cord c-peptide		Delivery/End of pregnancy
Other	Umbilical cord glucose		Delivery/End of pregnancy
Other	Neonatal body composition		Delivery/End of pregnancy
Primary	Rate of hypertensive disorders of pregnancy		Delivery/End of pregnancy
Secondary	Home glucose levels throughout pregnancy		Weekly, throughout pregnancy from enrollment to delivery
Secondary	Birthweight		Delivery/End of pregnancy
Secondary	Neonatal morbidity		Delivery/End of pregnancy