<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/NCT03767179</url>
  </required_header>
  <id_info>
    <org_study_id>KTU</org_study_id>
    <nct_id>NCT03767179</nct_id>
  </id_info>
  <brief_title>Research of Serum Procalcitonin, ESR, CRP And Leukocyte Levels in Fertile Missed Abortion Cases</brief_title>
  <official_title>Research of Serum Procalcitonin, Erythrocyte Sedimentation Rate, C-Reactive Protein And Leukocyte Levels in Fertile Missed Abortion Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karadeniz Technical University</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>
      Aim: The serum procalcitonin, erythrocyte sedimentation rate, c-reactive protein and&#xD;
      leukocyte values will be compared between fertile missed abortion diagnosed pregnants and&#xD;
      fertile normal pregnants to determine the presence of subclinical infection in the etiology&#xD;
      of missed abortion&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study group will consist of 30 fertile, under 35 years old women having for the first&#xD;
      time missed abortus diagnosis in the Obstetrics Department of Obstetrics and Gynecology of&#xD;
      Medicine Faculty of Karadeniz Technical University, Medical Faculty of Medicine. As control&#xD;
      group, 30 cases with the same trimester, fertile, and under 35 years old who had referred to&#xD;
      Obstetrics clinic, who had no systemic disease, will be included in the study. Blood samples&#xD;
      will be collected at the time of diagnosis of the patients with missed abortion and in normal&#xD;
      pregnancy in the week of 20th gestational week and will send to Biochemistry laboratory to&#xD;
      examine procalcitonin, erythrocyte sedimentation rate, c-reactive protein and leukocyte&#xD;
      values in their sera. The age, weight, gestational week, gravida (number), parity (number),&#xD;
      abortus (number), body mass index, systemic diseases, blood group, smoking information,&#xD;
      binary test results, and results of genetic analysis will be collected in both groups. The&#xD;
      pathology results of the missed abortion group will also be collected. The results will&#xD;
      statistically be compared in the SPSS 13.0 program in both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">May 15, 2018</completion_date>
  <primary_completion_date type="Actual">April 15, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum LC</measure>
    <time_frame>01.01.2018- 15.02.2019</time_frame>
    <description>Serum leukocyte count in number</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CRP</measure>
    <time_frame>01.01.2018- 15.02.2019</time_frame>
    <description>Serum CRP level in microgram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ESR</measure>
    <time_frame>01.01.2018- 15.02.2019</time_frame>
    <description>Erythrocyte sedimentation rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prokalsitonin</measure>
    <time_frame>01.01.2018- 15.02.2019</time_frame>
    <description>Serum procalcitonin level in microgram</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Abortion, Missed</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>The study group consisted of 30 fertile, under 35 years old women who were included in the study for the first time missed abortus diagnosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>30 cases with the same trimester, fertile, and under 35 years old who were referred to Obstetrics clinic, who had no systemic disease, were included in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>study</intervention_name>
    <description>procalcitonin, sedimentation, CRP, leukocyte identification</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Serum, abortion materials&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        60 pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fertile, less than 20 weeks of geese who have missed abortus for the first time&#xD;
             without systemic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to meet the missed abortus diagnostic criteria (for the group of fertile&#xD;
             missed abortus)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Rejection to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suleyman Guven, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>KaradenizTU Medicine Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karadeniz Technical University, Medical Faculty of Medicine.</name>
      <address>
        <city>Trabzon</city>
        <state>Ortahisar</state>
        <zip>61000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
    <investigator_full_name>Suleyman Guven</investigator_full_name>
    <investigator_title>Clinical Professor.</investigator_title>
  </responsible_party>
  <keyword>Missed abortion</keyword>
  <keyword>Procalcitonin</keyword>
  <keyword>Erythrocyte sedimentation rate (ESR)</keyword>
  <keyword>C-reactive protein (CRP)</keyword>
  <keyword>Leukocyte (WBC)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Missed</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/NCT03767179
org study id: KTU
nct id: NCT03767179
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim: The serum procalcitonin, erythrocyte sedimentation rate, c-reactive protein and
      leukocyte values will be compared between fertile missed abortion diagnosed pregnants and
      fertile normal pregnants to determine the presence of subclinical infection in the etiology
      of missed abortion
The study group will consist of 30 fertile, under 35 years old women having for the first
      time missed abortus diagnosis in the Obstetrics Department of Obstetrics and Gynecology of
      Medicine Faculty of Karadeniz Technical University, Medical Faculty of Medicine. As control
      group, 30 cases with the same trimester, fertile, and under 35 years old who had referred to
      Obstetrics clinic, who had no systemic disease, will be included in the study. Blood samples
      will be collected at the time of diagnosis of the patients with missed abortion and in normal
      pregnancy in the week of 20th gestational week and will send to Biochemistry laboratory to
      examine procalcitonin, erythrocyte sedimentation rate, c-reactive protein and leukocyte
      values in their sera. The age, weight, gestational week, gravida (number), parity (number),
      abortus (number), body mass index, systemic diseases, blood group, smoking information,
      binary test results, and results of genetic analysis will be collected in both groups. The
      pathology results of the missed abortion group will also be collected. The results will
      statistically be compared in the SPSS 13.0 program in both groups.
observational model: Case-Control
time perspective: Prospective
measure: Serum LC
time frame: 01.01.2018- 15.02.2019
description: Serum leukocyte count in number
measure: CRP
time frame: 01.01.2018- 15.02.2019
description: Serum CRP level in microgram
measure: ESR
time frame: 01.01.2018- 15.02.2019
description: Erythrocyte sedimentation rate
measure: Prokalsitonin
time frame: 01.01.2018- 15.02.2019
description: Serum procalcitonin level in microgram
arm group label: Study Group
description: The study group consisted of 30 fertile, under 35 years old women who were included in the study for the first time missed abortus diagnosis.
arm group label: Control Group
description: 30 cases with the same trimester, fertile, and under 35 years old who were referred to Obstetrics clinic, who had no systemic disease, were included in the study.
intervention type: Diagnostic Test
intervention name: study
description: procalcitonin, sedimentation, CRP, leukocyte identification
arm group label: Control Group
arm group label: Study Group
Blood Serum, abortion materials
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suleyman Guven, Prof
role: Principal Investigator
affiliation: KaradenizTU Medicine Faculty
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: Suleyman Guven
investigator title: Clinical Professor.
mesh term: Abortion, Missed
sharing ipd: No