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Sickle Cell Anemia Screening and Prevention in Northern Israel

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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

Tracking Information
First Submitted Date August 14, 2008
First Posted Date August 15, 2008
Last Update Posted Date September 1, 2015
Study Start Date May 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2008)
Number of carriers detected [ Time Frame: End of study ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 14, 2008)
Couples referred for prenatal diagnosis [ Time Frame: End of study ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sickle Cell Anemia Screening and Prevention in Northern Israel
Official Title Summary of the Data From the Prevention Programme for Hemoglobinopathies in Northern Israel
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Thalassemia
  • Sickle Cell Anemia
Intervention Other: Observational
Summary of data
Study Groups/Cohorts
  • A
    Thalassemia Minor carriers
    Intervention: Other: Observational
  • B
    Sickle cell carriers
    Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 30, 2015)
69
Original Estimated Enrollment
 (submitted: August 14, 2008)
100000
Actual Study Completion Date March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00735488
Other Study ID Numbers 0011-08-EMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Koren Ariel, HaEmek Medical Center, Israel
Study Sponsor HaEmek Medical Center, Israel
Collaborators Ministry of Health, Israel
Investigators
Principal Investigator: Ariel Koren, MD Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
PRS Account HaEmek Medical Center, Israel
Verification Date August 2015