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Metformin for the Treatment of Diabetes in Pregnancy

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ClinicalTrials.gov Identifier: NCT00414245
Recruitment Status : Unknown
Verified December 2006 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 21, 2006
Last Update Posted : December 21, 2006
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by:
Soroka University Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether metformin is effective and safe in the treatment of diabetes in pregnancy.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Diabetes Mellitus Type 2 Drug: metformin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin for the Treatment of Diabetes in Pregnancy
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. glycemic control
  2. pregnancy complications

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant women
  • GDM A2
  • diabetes mellitus type 2
  • singleton pregnancy

Exclusion Criteria:

  • diabetic nephropathy or proliferative retinopathy
  • cannot swallow tablets
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00414245


Contacts
Contact: Boaz Sheizaf, MD 972-54-2401191 bsheizaf@bgu.ac.il

Locations
Israel
Division of Obstetrics and Gynecology, Soroka University Medical Center Not yet recruiting
Beer-Sheva, Israel
Contact: Boaz Sheizaf, MD    972-54-2401191    bsheizaf@bgu.ac.il   
Principal Investigator: Boaz Sheizaf, MD         
Sponsors and Collaborators
Soroka University Medical Center
Ben-Gurion University of the Negev
Investigators
Principal Investigator: Boaz Sheizaf, MD division of obstetrics and gynecology, soroka university medical center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00414245     History of Changes
Other Study ID Numbers: sor434306ctil
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: December 21, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Diabetes Mellitus, Type 2
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs