We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sickle Cell Anemia Screening and Prevention in Northern Israel

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.
 
ClinicalTrials.gov Identifier: NCT00735488
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : September 1, 2015
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Since 1987, a screening for β Thalassemia in pregnant women is carried on in northern Israel, and from 1999 all the samples were tested also for Hgb S, Hgb C, Hgb D, Hgb O Arab and others.

In this study, the investigators intend to summarize the results of this preventive program aiming to detect couples at risk for having offspring with Thalassemia or SCA, the compliance regard to genetic counseling and prenatal diagnosis and the incidence of new affected babies born.


Condition or disease Intervention/treatment
Thalassemia Sickle Cell Anemia Other: Observational

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Summary of the Data From the Prevention Programme for Hemoglobinopathies in Northern Israel
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Thalassemia

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
A
Thalassemia Minor carriers
 Other: Observational
Summary of data
B
Sickle cell carriers
 Other: Observational
Summary of data


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of carriers detected [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. Couples referred for prenatal diagnosis [ Time Frame: End of study ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The program for prevention of hemoglobinopathies in Northern Israel, instituted since 1987, covered the northern part of Israel, including the Jezreel valley, the Nazareth area, the upper Galilee, the Hula valley and the northern part of the seashore region7. The overall population in this region is about a million inhabitants with about 50 % of Arab population, and a significant percentage of them from Bedouin origin, a population that at least partially is of African origin.
Criteria

Inclusion Criteria: All pregnant women tested and their husband in those cases that the woman test revealed abnormal hemoglobin.

Exclusion Criteria: No exclusion criteria.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts 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): NCT00735488


Locations
Layout table for location information
Israel
Pediatric Hematology Unit - Ha'Emek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Ministry of Health, Israel
Investigators
Layout table for investigator information
Principal Investigator: Ariel Koren, MD Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00735488    
Other Study ID Numbers: 0011-08-EMC
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by Dr Koren Ariel, HaEmek Medical Center, Israel:
Thalassemia
Sickle cell anemia
Carrier detection
Prenatal Diagnosis
Genetic counseling
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Thalassemia
Anemia, Sickle Cell
Hematologic Diseases
 Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn