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

Phase 4

Active, not recruiting

• Conditions: Pregnancy in Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: Metformin

• Registration Number: NCT03570632
• Lead Sponsor: Maisa N. Feghali, MD

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-27
• Study Start: 2019-07-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Rate of hypertensive disorders of pregnancy	Delivery/End of pregnancy

Secondary Outcome Measures

Name	Time	Method
Home glucose levels throughout pregnancy	Weekly, throughout pregnancy from enrollment to delivery
Birthweight	Delivery/End of pregnancy
Neonatal morbidity	Delivery/End of pregnancy

Trial Locations

Locations (1)

Magee Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States