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The Effect of Diabetes on the Newborn

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00831519
First Posted: January 29, 2009
Last Update Posted: June 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
  Purpose
The aim of this study is to test and compare biochemical, hematological, and inflammatory factors in diabetic and healthy pregnant mothers and in their newborns.

Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biochemical, Hematologic, and Inflammatory Effects of Diabetes on the Newborn

Further study details as provided by Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • oxidative stress [ Time Frame: Immediately after delivery by cesarean section ]
    New borns of diabetic mother may have oxidative stress


Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Macrosomial, GD
Macrosomial, control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who plan to deliver at Western Galilee Hospital
Criteria

Inclusion Criteria:

  • pregnant women

Exclusion Criteria:

  Contacts and Locations
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): NCT00831519


Contacts
Contact: Ella Ophir, MD (4)9107517

Locations
Israel
Western Galilee Hospital- Nahariya Recruiting
Nahariya, Israel
Contact: Ophir       ella.ophir@naharia.health.gov.il   
Principal Investigator: Ella Ophir, MD         
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

Responsible Party: Prof. Jacob Bornstein, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT00831519     History of Changes
Other Study ID Numbers: JB_6.08_1
First Submitted: January 28, 2009
First Posted: January 29, 2009
Last Update Posted: June 20, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases