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

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ClinicalTrials.gov Identifier: NCT03570632
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Maisa N. Feghali, MD, University of Pittsburgh

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
Diabetes Mellitus, Type 1 Pregnancy in Diabetes Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


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




Primary Outcome Measures :
  1. Rate of hypertensive disorders of pregnancy [ Time Frame: Delivery/End of pregnancy ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only pregnant women are eligible to participate in the study
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570632


Contacts
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Contact: Maisa N Feghali, MD 4126471000 feghalim@upmc.edu

Locations
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United States, Pennsylvania
Magee Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Maisa Feghali, MD    412-647-1000    feghalim@upmc.edu   
Principal Investigator: Maisa Feghali, MD         
Sponsors and Collaborators
Maisa N. Feghali, MD
Investigators
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Principal Investigator: Maisa N Feghali, MD University of Pittsburgh

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Responsible Party: Maisa N. Feghali, MD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03570632     History of Changes
Other Study ID Numbers: PRO18050459
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pre-Eclampsia
Pregnancy in Diabetics
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs