<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/NCT03808571</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03808571</nct_id>
  </id_info>
  <brief_title>Cord Blood Nesfatin-1 and Irisin in the Intrauterine Growth Restricted Fetuses</brief_title>
  <official_title>The Association of Cord Blood Nesfatin-1 and Irisin Level With Fetal Doppler Parameters in Pregnancies Complicated With Intrauterine Growth Restricted Fetuses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl 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>
      : The aim of this study is to investigate Cord blood irisin and nesfatin-1 levels in&#xD;
      pregnancies with intrauterine growth retardation and to determine whether they are associated&#xD;
      with abnormal fetal doppler findings or not.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted at Yüzüncü Yıl University Medical Faculty Obstetrics and Gynecology&#xD;
      Clinic. The study group included 34 pregnant women ranged from 18 to 45 years old who have&#xD;
      intrauterine growth retardation and underwent ceseraen section. 32 pregnant women who had no&#xD;
      abnormality on prenatal follow-up and underwent elective ceserean seciton served as control&#xD;
      group. The maternal age, height, weight, body mass index (BMI), systolic and diastolic blood&#xD;
      pressures were recorded in both groups of patients. Maternal serum total blood count and&#xD;
      biochemical parameters were obtained from the laboratory parameters. Gestational week at&#xD;
      birth, birth weight, sex, 1st and 5th minute APGAR scores were recorded. Blood samples were&#xD;
      collected from all the cases during the cesarean section for measurmenet of nesfatin-1 and&#xD;
      irisin by doubly clamped umbilical cord. Blood samples were immediately centrifuged in&#xD;
      sterile tubes and maintained at -80 ° C until assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</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>cord blood nesfatn-1 level measurement</measure>
    <time_frame>9 months</time_frame>
    <description>cord blood levels of nesfatin-1 in pregnancies with intrauterine growth restricted fetuses and healthy pregnancies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cord blood irisin level measurement</measure>
    <time_frame>9 months</time_frame>
    <description>ord blood levels of irisin in pregnancies with intrauterine growth restricted fetuses and healthy pregnancies.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Nesfatin-1</condition>
  <condition>Irisin</condition>
  <condition>Intrauterine Growth Restriction</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Pregnancies complicated with intrauterine growth restricted fetuses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy pregnancies</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cord blood specimen during the delivery</intervention_name>
    <description>The cord blood will be taken during the delivery of baby.</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>
      cord blood specimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with intrauterine grwoth rectricted fetuses.&#xD;
&#xD;
          -  Healthy pregnancies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with chronic medical conditions&#xD;
&#xD;
          -  multiple pregnancies&#xD;
&#xD;
          -  fetuses with fetal malfomations or genetic syndromes&#xD;
&#xD;
          -  pregnant women older than 45 years old&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology</name>
      <address>
        <city>Van</city>
        <zip>65000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>erbil karaman</investigator_full_name>
    <investigator_title>Associate doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Growth Retardation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03808571
org study id: 1
nct id: NCT03808571
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
: The aim of this study is to investigate Cord blood irisin and nesfatin-1 levels in
      pregnancies with intrauterine growth retardation and to determine whether they are associated
      with abnormal fetal doppler findings or not.
This study was conducted at Yüzüncü Yıl University Medical Faculty Obstetrics and Gynecology
      Clinic. The study group included 34 pregnant women ranged from 18 to 45 years old who have
      intrauterine growth retardation and underwent ceseraen section. 32 pregnant women who had no
      abnormality on prenatal follow-up and underwent elective ceserean seciton served as control
      group. The maternal age, height, weight, body mass index (BMI), systolic and diastolic blood
      pressures were recorded in both groups of patients. Maternal serum total blood count and
      biochemical parameters were obtained from the laboratory parameters. Gestational week at
      birth, birth weight, sex, 1st and 5th minute APGAR scores were recorded. Blood samples were
      collected from all the cases during the cesarean section for measurmenet of nesfatin-1 and
      irisin by doubly clamped umbilical cord. Blood samples were immediately centrifuged in
      sterile tubes and maintained at -80 ° C until assessed.
observational model: Case-Control
time perspective: Prospective
measure: cord blood nesfatn-1 level measurement
time frame: 9 months
description: cord blood levels of nesfatin-1 in pregnancies with intrauterine growth restricted fetuses and healthy pregnancies.
measure: Cord blood irisin level measurement
time frame: 9 months
description: ord blood levels of irisin in pregnancies with intrauterine growth restricted fetuses and healthy pregnancies.
arm group label: Study group
description: Pregnancies complicated with intrauterine growth restricted fetuses
arm group label: Control group
description: Healthy pregnancies
intervention type: Other
intervention name: cord blood specimen during the delivery
description: The cord blood will be taken during the delivery of baby.
arm group label: Control group
arm group label: Study group
cord blood specimen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: erbil karaman
investigator title: Associate doctor
mesh term: Fetal Growth Retardation
sharing ipd: Undecided