Summary of the Data From the Prevention Programme for Hemoglobinopathies in Northern Israel
Sickle Cell Anemia Screening and Prevention in Northern Israel
Sponsors
Source
HaEmek Medical Center, Israel
Oversight Info
Has Dmc
Yes
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.
Overall Status
Completed
Start Date
2008-05-01
Completion Date
2009-03-01
Primary Completion Date
2009-03-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Number of carriers detected |
End of study |
Secondary Outcome
Measure |
Time Frame |
|
Couples referred for prenatal diagnosis |
End of study |
Number Of Groups
2
Enrollment
69
Conditions
Intervention
Eligibility
Study Pop
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.
Sampling Method
Probability Sample
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ariel Koren, MD |
Principal Investigator |
Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel |
Location
Facility |
|
Pediatric Hematology Unit - Ha'Emek Medical Center Afula 18101 Israel |
Location Countries
Country
Israel
Verification Date
2015-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
HaEmek Medical Center, Israel
Investigator Full Name
Dr Koren Ariel
Investigator Title
Head of Pediatric Hematology Unit and Pediatric Dpt B
Keywords
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
A
Description
Thalassemia Minor carriers
Arm Group Label
B
Description
Sickle cell carriers
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Retrospective
Study First Submitted
August 14, 2008
Study First Submitted Qc
August 14, 2008
Study First Posted
August 15, 2008
Last Update Submitted
August 30, 2015
Last Update Submitted Qc
August 30, 2015
Last Update Posted
September 1, 2015
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.