<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01662596</url>
  </required_header>
  <id_info>
    <org_study_id>0044-12-HYMC</org_study_id>
    <nct_id>NCT01662596</nct_id>
  </id_info>
  <brief_title>Detection of Risk Factors for Fetal Anomalies in a Rural Hospital Population</brief_title>
  <official_title>Detection of Risk Factors for Fetal Anomalies in a Rural Hospital Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to estimate the rate of risk factors for appearance of disease or&#xD;
      fetal malformations in a population who turn to hospital &quot;Hillel Yaffe&quot; and examine whether&#xD;
      there is a difference in the rate of early testing for diseases or birth defects in the&#xD;
      fetus.&#xD;
&#xD;
      Understanding the population and its risk factors, will allow specific reference to these&#xD;
      risk factors to lowering them to eventually reduce the rate of congenital malformations in&#xD;
      this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Major defects prevalence in the general population is estimated at 5% of all live births. In&#xD;
      cases where the fetus suffers from structural defect, chromosomal or genetic disease,&#xD;
      prenatal diagnosis is an important scientific tool that allows reliable advice and better&#xD;
      pregnancy outcomes.&#xD;
&#xD;
      Diseases and many embryonic defects can be detected early, including nervous system defects,&#xD;
      heart defects, urinary tract defects, limb defects and more. Taking folic acid before&#xD;
      pregnancy and during the first trimester reduces the incidence of some of these defects.&#xD;
&#xD;
      Aneuploidy and mainly trisomy 21,18,13, Monosomy X and aneuploid in sex chromosome is&#xD;
      responsible for most of the chromosomal anomalies. Some of aneuploidy can be diagnosed by a&#xD;
      combination of nuchal translucency (also associated with cardiac abnormalities) and maternal&#xD;
      serum markers detection in the first trimester of pregnancy or a laboratory test in the&#xD;
      second trimester. Ultrasound is also a tool for diagnosis of aneuploidity, which detecting&#xD;
      abnormalities characteristic or &quot;soft signs&quot; who suspicious in chromosomal disorder.&#xD;
&#xD;
      Genetic tests is another diagnostic tool that suggested to general population and in&#xD;
      individual cases adapted to genetic diseases that are known.&#xD;
&#xD;
      In 2008 about 75.5% of the population in Israel were Jews, 20.2% Arabs, and 4.3 were defined&#xD;
      as &quot;others&quot;. Approximately 45% of Arabs living in the northern region compared to 10% of the&#xD;
      Jewish population. Congenital malformations were the leading cause of death in infants Arab&#xD;
      and the second cause of death in Jewish infants.&#xD;
&#xD;
      In recent years the supply of screening before and during pregnancy has increased, but it is&#xD;
      apparent that the rate of implementation of nuchal translucency, amniocentesis and therefore&#xD;
      detection of disease are lower in Arab population, as well as the rates of taking folic acid.&#xD;
      These differences between populations in carrying out tests that enable prevention and early&#xD;
      detection of birth defects and neonatal genetic diseases also associated with differences in&#xD;
      economic, religious and age of the woman.&#xD;
&#xD;
      In this work we try to know the population applying for medical services at Hillel Yaffe&#xD;
      Hospital. Estimate the rate of risk factors for appearance of disease or fetal malformations&#xD;
      in a population who turn to hospital &quot;Hillel Yaffe&quot; and examine whether there is a difference&#xD;
      in the rate of early testing for diseases or birth defects in the fetus.&#xD;
&#xD;
      We hypothesize that a large percentage of the population who turn to Hillel Yaffe Hospital&#xD;
      has risk factors for having a sick fetus and the Muslim population is in higher risk than the&#xD;
      Jewish population.&#xD;
&#xD;
      Understanding the population and its risk factors, will allow specific reference to these&#xD;
      risk factors to lowering them to eventually reduce the rate of congenital malformations in&#xD;
      this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Pregnancy</condition>
  <condition>Pregnancy Complications</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women who address the emergency room, Ultrasound unit or foreign clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who address the emergency room, Ultrasound unit or foreign clinics in&#xD;
             the second or third trimester.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women in the first trimester Pregnant women who doesn't want to participate.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yael yagur, student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Technion, Israel Institute of Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alon Shrin, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Ultrasound unit manager, obstetric and gynaecology, Hillel Yaffe</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yael Yagur, student</last_name>
    <phone>972-52-3309429</phone>
    <email>yaelyagur@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alon Shrim, M.D.</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Obstetric and Gynaecology Department</name>
      <address>
        <city>Hadera</city>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>yael yagur, student</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 8, 2012</last_update_submitted>
  <last_update_submitted_qc>August 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Risk factors,</keyword>
  <keyword>prenatal diagnosis,</keyword>
  <keyword>fetal malformations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01662596
org study id: 0044-12-HYMC
nct id: NCT01662596
lead sponsor: 
has dmc: Yes
The purpose of the study is to estimate the rate of risk factors for appearance of disease or
      fetal malformations in a population who turn to hospital "Hillel Yaffe" and examine whether
      there is a difference in the rate of early testing for diseases or birth defects in the
      fetus.

      Understanding the population and its risk factors, will allow specific reference to these
      risk factors to lowering them to eventually reduce the rate of congenital malformations in
      this population.
Major defects prevalence in the general population is estimated at 5% of all live births. In
      cases where the fetus suffers from structural defect, chromosomal or genetic disease,
      prenatal diagnosis is an important scientific tool that allows reliable advice and better
      pregnancy outcomes.

      Diseases and many embryonic defects can be detected early, including nervous system defects,
      heart defects, urinary tract defects, limb defects and more. Taking folic acid before
      pregnancy and during the first trimester reduces the incidence of some of these defects.

      Aneuploidy and mainly trisomy 21,18,13, Monosomy X and aneuploid in sex chromosome is
      responsible for most of the chromosomal anomalies. Some of aneuploidy can be diagnosed by a
      combination of nuchal translucency (also associated with cardiac abnormalities) and maternal
      serum markers detection in the first trimester of pregnancy or a laboratory test in the
      second trimester. Ultrasound is also a tool for diagnosis of aneuploidity, which detecting
      abnormalities characteristic or "soft signs" who suspicious in chromosomal disorder.

      Genetic tests is another diagnostic tool that suggested to general population and in
      individual cases adapted to genetic diseases that are known.

      In 2008 about 75.5% of the population in Israel were Jews, 20.2% Arabs, and 4.3 were defined
      as "others". Approximately 45% of Arabs living in the northern region compared to 10% of the
      Jewish population. Congenital malformations were the leading cause of death in infants Arab
      and the second cause of death in Jewish infants.

      In recent years the supply of screening before and during pregnancy has increased, but it is
      apparent that the rate of implementation of nuchal translucency, amniocentesis and therefore
      detection of disease are lower in Arab population, as well as the rates of taking folic acid.
      These differences between populations in carrying out tests that enable prevention and early
      detection of birth defects and neonatal genetic diseases also associated with differences in
      economic, religious and age of the woman.

      In this work we try to know the population applying for medical services at Hillel Yaffe
      Hospital. Estimate the rate of risk factors for appearance of disease or fetal malformations
      in a population who turn to hospital "Hillel Yaffe" and examine whether there is a difference
      in the rate of early testing for diseases or birth defects in the fetus.

      We hypothesize that a large percentage of the population who turn to Hillel Yaffe Hospital
      has risk factors for having a sick fetus and the Muslim population is in higher risk than the
      Jewish population.

      Understanding the population and its risk factors, will allow specific reference to these
      risk factors to lowering them to eventually reduce the rate of congenital malformations in
      this population.
time perspective: Cross-Sectional
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: yael yagur, student
role: Principal Investigator
affiliation: Technion, Israel Institute of Technology
last name: Alon Shrin, M.D.
role: Study Director
affiliation: Ultrasound unit manager, obstetric and gynaecology, Hillel Yaffe
last name: Yael Yagur, student
phone: 972-52-3309429
email: yaelyagur@gmail.com
last name: Alon Shrim, M.D.
facility: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Pregnancy Complications
mesh term: Congenital Abnormalities