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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
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya Identifier:
First received: January 28, 2009
Last updated: June 19, 2014
Last verified: June 2014
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.


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)
Macrosomial, GD
Macrosomial, control


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

Inclusion Criteria:

  • pregnant women

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00831519

Contact: Ella Ophir, MD (4)9107517

Western Galilee Hospital- Nahariya Recruiting
Nahariya, Israel
Contact: Ophir   
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 Identifier: NCT00831519     History of Changes
Other Study ID Numbers: JB_6.08_1
Study First Received: January 28, 2009
Last Updated: June 19, 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 22, 2017