Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 1, Pregnancy in Diabetes
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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).
Sites / Locations
- Magee Womens Hospital of UPMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care
Metformin
Arm Description
Outcomes
Primary Outcome Measures
Rate of hypertensive disorders of pregnancy
Secondary Outcome Measures
Home glucose levels throughout pregnancy
Birthweight
Neonatal morbidity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03570632
Brief Title
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Official Title
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maisa N. Feghali, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Pregnancy in Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Metformin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy
Primary Outcome Measure Information:
Title
Rate of hypertensive disorders of pregnancy
Time Frame
Delivery/End of pregnancy
Secondary Outcome Measure Information:
Title
Home glucose levels throughout pregnancy
Time Frame
Weekly, throughout pregnancy from enrollment to delivery
Title
Birthweight
Time Frame
Delivery/End of pregnancy
Title
Neonatal morbidity
Time Frame
Delivery/End of pregnancy
Other Pre-specified Outcome Measures:
Title
Gestational weight gain
Time Frame
At time of prenatal visits, throughout pregnancy from enrollment to delivery
Title
Umbilical cord c-peptide
Time Frame
Delivery/End of pregnancy
Title
Umbilical cord glucose
Time Frame
Delivery/End of pregnancy
Title
Neonatal body composition
Time Frame
Delivery/End of pregnancy
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only pregnant women are eligible to participate in the study
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maisa N Feghali, MD
Phone
4126471000
Email
feghalim@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maisa N Feghali, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maisa Feghali, MD
Phone
412-647-1000
Email
feghalim@upmc.edu
First Name & Middle Initial & Last Name & Degree
Maisa Feghali, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
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