<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/NCT03798964</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-0119-18</org_study_id>
    <nct_id>NCT03798964</nct_id>
  </id_info>
  <brief_title>The Expression Heparanase in Term and Preterm Placentas</brief_title>
  <official_title>The Expression Heparanase in Term and Preterm Placentas</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of&#xD;
      heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM).&#xD;
&#xD;
      This study aims to investigate the association between heparanase expression in the human&#xD;
      placenta and preterm birth (PTB) .&#xD;
&#xD;
      The investigators hypothesize that an abnormal placentation causes relative placental&#xD;
      ischemia that induces higher rates of heparanase expression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">November 24, 2020</completion_date>
  <primary_completion_date type="Actual">November 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Heparanase expression</measure>
    <time_frame>Six months</time_frame>
    <description>Heparanase expression in the human placenta following delivery will be evaluated by western blot analysis in the three groups and will be compared to determine differences in the levels.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Preterm Birth</condition>
  <arm_group>
    <arm_group_label>Elective term cesarean</arm_group_label>
    <description>Low-risk women undergoing elective term cesarean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Term vaginal delivery</arm_group_label>
    <description>Low-risk women undergoing term vaginal delivery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preterm vaginal delivery</arm_group_label>
    <description>Women undergoing preterm vaginal delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placental analysis</intervention_name>
    <description>Analysis of placenta to determine expression of heparanase</description>
    <arm_group_label>Elective term cesarean</arm_group_label>
    <arm_group_label>Preterm vaginal delivery</arm_group_label>
    <arm_group_label>Term vaginal delivery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women attending our obstetrical unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High-risk patients&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Significant maternal illness&#xD;
&#xD;
          -  Significant fetal anomaly&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rinat Gabbay-Benziv, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hille Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>June 22, 2022</last_update_submitted>
  <last_update_submitted_qc>June 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03798964
org study id: HYMC-0119-18
nct id: NCT03798964
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of
      heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM).

      This study aims to investigate the association between heparanase expression in the human
      placenta and preterm birth (PTB) .

      The investigators hypothesize that an abnormal placentation causes relative placental
      ischemia that induces higher rates of heparanase expression.
observational model: Cohort
time perspective: Prospective
measure: Heparanase expression
time frame: Six months
description: Heparanase expression in the human placenta following delivery will be evaluated by western blot analysis in the three groups and will be compared to determine differences in the levels.
arm group label: Elective term cesarean
description: Low-risk women undergoing elective term cesarean section
arm group label: Term vaginal delivery
description: Low-risk women undergoing term vaginal delivery
arm group label: Preterm vaginal delivery
description: Women undergoing preterm vaginal delivery
intervention type: Other
intervention name: Placental analysis
description: Analysis of placenta to determine expression of heparanase
arm group label: Elective term cesarean
arm group label: Preterm vaginal delivery
arm group label: Term vaginal delivery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Rinat Gabbay-Benziv, MD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: No