<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/NCT02192177</url>
  </required_header>
  <id_info>
    <org_study_id>M30 Intrahepatic cholestasis</org_study_id>
    <nct_id>NCT02192177</nct_id>
  </id_info>
  <brief_title>Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.</brief_title>
  <official_title>Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zekai Tahir Burak Women's Health Research and Education Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zekai Tahir Burak Women's Health Research and Education Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially&#xD;
      late second and third trimester. We aimed to investigate the role of apoptosis in&#xD;
      etiopathogenesis of obstetric cholestasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      M30 (caspases cleaved Cytokeratin-18 (CK-18) fragment) is a specific apoptosis marker. We&#xD;
      aimed to use it to evaluate the apoptotic process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>M30 value as Unit per Liter.</measure>
    <time_frame>Four months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of delivery with cesarean section.</measure>
    <time_frame>Four months.</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Pregnant subjects diagnosed with obstetric cholestasis who didn't have any foreknown systemic disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>entirely healthy pregnant subjects, the control group.</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal venous and umbilical cord blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Late second or third trimester of pregnancy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Foreknown systemic diseases, multiple pregnancy, smoking cigarettes.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali O Ersoy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical doctor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ali O Ersoy</last_name>
    <phone>+905056579157</phone>
    <email>draliersoy@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zekai Tahir Burak Maternity Teaching Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali O Ersoy</last_name>
      <phone>+905056579157</phone>
      <email>draliersoy@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Ali O Ersoy</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Del Ben M, Polimeni L, Baratta F, Bartimoccia S, Carnevale R, Loffredo L, Pignatelli P, Violi F, Angelico F. Serum Cytokeratin-18 Is Associated with NOX2-Generated Oxidative Stress in Patients with Nonalcoholic Fatty Liver. Int J Hepatol. 2014;2014:784985. doi: 10.1155/2014/784985. Epub 2014 Jan 29.</citation>
    <PMID>24678423</PMID>
  </reference>
  <reference>
    <citation>Du Q, Zhang Y, Pan Y, Duan T. Lithocholic acid-induced placental tumor necrosis factor-alpha upregulation and syncytiotrophoblast cell apoptosis in intrahepatic cholestasis of pregnancy. Hepatol Res. 2014 May;44(5):532-41. doi: 10.1111/hepr.12150. Epub 2013 May 31.</citation>
    <PMID>23627780</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zekai Tahir Burak Women's Health Research and Education Hospital</investigator_affiliation>
    <investigator_full_name>Ali Ozgur Ersoy</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Apoptosis</keyword>
  <keyword>intrahepatic cholestasis</keyword>
  <keyword>obstetric outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholestasis</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/NCT02192177
org study id: M30 Intrahepatic cholestasis
nct id: NCT02192177
lead sponsor: 
has dmc: Yes
Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially
      late second and third trimester. We aimed to investigate the role of apoptosis in
      etiopathogenesis of obstetric cholestasis.
M30 (caspases cleaved Cytokeratin-18 (CK-18) fragment) is a specific apoptosis marker. We
      aimed to use it to evaluate the apoptotic process.
observational model: Case-Control
time perspective: Prospective
measure: M30 value as Unit per Liter.
time frame: Four months.
measure: Percentage of delivery with cesarean section.
time frame: Four months.
arm group label: Group 1
description: Pregnant subjects diagnosed with obstetric cholestasis who didn't have any foreknown systemic disease.
arm group label: Group 2
description: entirely healthy pregnant subjects, the control group.
Maternal venous and umbilical cord blood.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ali O Ersoy
role: Principal Investigator
affiliation: Medical doctor
last name: Ali O Ersoy
phone: +905056579157
email: draliersoy@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
citation: Del Ben M, Polimeni L, Baratta F, Bartimoccia S, Carnevale R, Loffredo L, Pignatelli P, Violi F, Angelico F. Serum Cytokeratin-18 Is Associated with NOX2-Generated Oxidative Stress in Patients with Nonalcoholic Fatty Liver. Int J Hepatol. 2014;2014:784985. doi: 10.1155/2014/784985. Epub 2014 Jan 29.
PMID: 24678423
citation: Du Q, Zhang Y, Pan Y, Duan T. Lithocholic acid-induced placental tumor necrosis factor-alpha upregulation and syncytiotrophoblast cell apoptosis in intrahepatic cholestasis of pregnancy. Hepatol Res. 2014 May;44(5):532-41. doi: 10.1111/hepr.12150. Epub 2013 May 31.
PMID: 23627780
responsible party type: Principal Investigator
investigator affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
investigator full name: Ali Ozgur Ersoy
investigator title: Medical Doctor
mesh term: Cholestasis