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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

Tracking Information
First Submitted Date  ICMJE June 15, 2018
First Posted Date  ICMJE June 27, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE July 8, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
Rate of hypertensive disorders of pregnancy [ Time Frame: Delivery/End of pregnancy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03570632 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • Home glucose levels throughout pregnancy [ Time Frame: Weekly, throughout pregnancy from enrollment to delivery ]
  • Birthweight [ Time Frame: Delivery/End of pregnancy ]
  • Neonatal morbidity [ Time Frame: Delivery/End of pregnancy ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2018)
  • Gestational weight gain [ Time Frame: At time of prenatal visits, throughout pregnancy from enrollment to delivery ]
  • Umbilical cord c-peptide [ Time Frame: Delivery/End of pregnancy ]
  • Umbilical cord glucose [ Time Frame: Delivery/End of pregnancy ]
  • Neonatal body composition [ Time Frame: Delivery/End of pregnancy ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Official Title  ICMJE Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Pregnancy in Diabetes
Intervention  ICMJE Drug: Metformin
Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy
Study Arms  ICMJE
  • No Intervention: Usual care
  • Experimental: Metformin
    Intervention: Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only pregnant women are eligible to participate in the study
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maisa N Feghali, MD 4126471000 feghalim@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03570632
Other Study ID Numbers  ICMJE PRO18050459
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maisa N. Feghali, MD, University of Pittsburgh
Study Sponsor  ICMJE Maisa N. Feghali, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maisa N Feghali, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP