Sickle Cell Anemia Screening and Prevention in Northern Israel

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by HaEmek Medical Center, Israel
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00735488
First received: August 14, 2008
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention
Thalassemia
Sickle Cell Anemia
Other: Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Summary of the Data From the Prevention Programme for Hemoglobinopathies in Northern Israel

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Number of carriers detected [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Couples referred for prenatal diagnosis [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100000
Study Start Date: May 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Thalassemia Minor carriers
Other: Observational
Summary of data
B
Sickle cell carriers
Other: Observational
Summary of data

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00735488

Contacts
Contact: Ariel Koren, MD 972-4-6495576 ext 5576 koren_a@clalit.org.il

Locations
Israel
Pediatric Hematology Unit - Ha'Emek Medical Center Recruiting
Afula, Israel, 18101
Contact: Ariel Koren, MD    972-4-6495576 ext 5576    koren_a@clalit.org.il   
Sub-Investigator: Carina Levin, MD         
Sub-Investigator: Luci Zalman, PhD         
Sub-Investigator: Ronit BGril Zamir, Msc         
Sub-Investigator: Stavit Shalev, MD         
Sub-Investigator: Haya Palmor         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Ministry of Health, Israel
Investigators
Principal Investigator: Ariel Koren, MD Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00735488     History of Changes
Other Study ID Numbers: 0011-08-EMC
Study First Received: August 14, 2008
Last Updated: July 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Thalassemia
Sickle cell anemia
Carrier detection
Prenatal Diagnosis
Genetic counseling

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Thalassemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 26, 2014