<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/NCT02995356</url>
  </required_header>
  <id_info>
    <org_study_id>2.101.2015.0076</org_study_id>
    <nct_id>NCT02995356</nct_id>
  </id_info>
  <brief_title>Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</source>
  <brief_summary>
    <textblock>
      Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients&#xD;
      will be determined with using irregular increased human chorionic gonadotropin (beta-HCG)&#xD;
      results and no embryo reported ultrasonography results. Plasma and cervical fluid samples&#xD;
      will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase&#xD;
      levels of samples will be compared between patients who have doubt for ectopic pregnancy and&#xD;
      patients who have intrauterine pregnancy. Concentration of these proteins in samples will be&#xD;
      evaluated. If any difference will be found between groups in favour of ectopic pregnancy,&#xD;
      these results might be interpreted as these proteins useful for early detecting of the&#xD;
      ectopic pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of Axonemal Dynein Heavy Chain 5</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of creatine kinase</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">85</enrollment>
  <condition>Ectopic Pregnancy</condition>
  <arm_group>
    <arm_group_label>Doubt for ectopic pregnancy group</arm_group_label>
    <description>This group participants have doubt for ectopic pregnancy in terms of beta-HCG pregnancy follow-up results and ultrasonography results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal intrauterine pregnancy group</arm_group_label>
    <description>This groups participants have normal intrauterine pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collecting cervical liquid and sera samples</intervention_name>
    <arm_group_label>Doubt for ectopic pregnancy group</arm_group_label>
    <arm_group_label>Normal intrauterine pregnancy group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have doubt for ectopic pregnancy will be selected for study group and patients&#xD;
        who have intrauterine pregnancy will be selected for control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Doubted ectopic pregnancy&#xD;
&#xD;
          -  Without any finding about intrauterine pregnancy in ultrasonography results&#xD;
&#xD;
          -  Without any vaginal bleeding&#xD;
&#xD;
          -  Having irregular pregnancy test results&#xD;
&#xD;
          -  Beta-HCG results should be at least upper than 100 milli-International unit (mIU/ml)&#xD;
&#xD;
          -  Having fist trimester pregnancy for intrauterine pregnancy group&#xD;
&#xD;
          -  Without any emergency findings&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Doubted incomplete abortion&#xD;
&#xD;
          -  Having vaginal bleeding&#xD;
&#xD;
          -  Having ultrasound results which include intrauterine embryo report&#xD;
&#xD;
          -  Having lower than 100 mIU/ml beta-HCG results&#xD;
&#xD;
          -  Without fetal heart rate in intrauterine pregnancy group&#xD;
&#xD;
          -  Having older than fist trimester pregnancy for intrauterine pregnancy group&#xD;
&#xD;
          -  Having emergency findings&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ege University, Medicine Faculty, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Cagdas Sahin</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Ectopic pregnancy</keyword>
  <keyword>Axonemal Dynein Heavy Chain 5</keyword>
  <keyword>Creatine Kinase</keyword>
  <keyword>Cervical fluid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy, Ectopic</mesh_term>
    <mesh_term>Cardiac Complexes, Premature</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/NCT02995356
org study id: 2.101.2015.0076
nct id: NCT02995356
lead sponsor: 
Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients
      will be determined with using irregular increased human chorionic gonadotropin (beta-HCG)
      results and no embryo reported ultrasonography results. Plasma and cervical fluid samples
      will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase
      levels of samples will be compared between patients who have doubt for ectopic pregnancy and
      patients who have intrauterine pregnancy. Concentration of these proteins in samples will be
      evaluated. If any difference will be found between groups in favour of ectopic pregnancy,
      these results might be interpreted as these proteins useful for early detecting of the
      ectopic pregnancy.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Concentration of Axonemal Dynein Heavy Chain 5
time frame: 1 year
measure: Concentration of creatine kinase
time frame: 1 year
arm group label: Doubt for ectopic pregnancy group
description: This group participants have doubt for ectopic pregnancy in terms of beta-HCG pregnancy follow-up results and ultrasonography results.
arm group label: Normal intrauterine pregnancy group
description: This groups participants have normal intrauterine pregnancy
intervention type: Other
intervention name: Collecting cervical liquid and sera samples
arm group label: Doubt for ectopic pregnancy group
arm group label: Normal intrauterine pregnancy group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Cagdas Sahin
investigator title: MD
mesh term: Pregnancy, Ectopic
mesh term: Cardiac Complexes, Premature