The Effect of Diabetes on the Newborn

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Western Galilee Hospital-Nahariya
Sponsor:
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00831519
First received: January 28, 2009
Last updated: June 19, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • oxidative stress [ Time Frame: Immediately after delivery by cesarean section ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 28, 2009
Last Updated: June 19, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on October 02, 2014