<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/NCT02976311</url>
  </required_header>
  <id_info>
    <org_study_id>E52332816_51</org_study_id>
    <nct_id>NCT02976311</nct_id>
  </id_info>
  <brief_title>Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques</brief_title>
  <acronym>C/S</acronym>
  <official_title>Comparison of Inflammatory Reactions Following Two Different Cesarean Surgery Techniques; The Modified Misgav-Ladach Versus the Pfannenstiel-Kerr Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kayseri Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kayseri Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aimed to find out whether there are any differences in&#xD;
      inflammatory reactions occured subsequent to two different cesarean delivery techniques;&#xD;
      modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cesarean section is one of the most undertaken operations in women of childbearing age.&#xD;
      However, there is not a unique cesarean surgery technique. Pfannenstiel , reported his own&#xD;
      technique in 1897. Because of the applicability of the technique, it went down well among&#xD;
      obstetricians. After three decades, Kerr evolved this technique, and Pfannenstiel-Kerr&#xD;
      technique became the method of choice until late 70's. In 1972, Stark et al defined the&#xD;
      Misgav Ladach technique and in the following years this technique became popular among&#xD;
      obstetricians. In late 80's Misgav Ladach technique was modified and started to be more&#xD;
      popular. But, still Pfannenstiel-Kerr technique continued to be used frequently and studies&#xD;
      comparing clinical outcomes of these two techniques were conducted for several times.&#xD;
      However, the inflammatory responses which occured subsequent to application of these&#xD;
      techniques were not investigated. This is the first study investigating the inflammatory&#xD;
      response emerged after different cesarean surgery techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL-6</measure>
    <time_frame>24 hours</time_frame>
    <description>percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TNF-alpha</measure>
    <time_frame>24 hours</time_frame>
    <description>percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Delivery</condition>
  <condition>Cesarean Delivery</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Misgav-Ladach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cesarean section(C/S) via the modified 'Misgav-Ladach' technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pfannenstiel-Kerr</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cesarean section(C/S) via the 'Pfannenstiel-Kerr' technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cesarean section(C/S) via the modified Misgav-Ladach technique</intervention_name>
    <description>the first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique</description>
    <arm_group_label>Misgav-Ladach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cesarean section via the Pfannenstiel-Kerr technique</intervention_name>
    <description>the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique</description>
    <arm_group_label>Pfannenstiel-Kerr</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cesarean section for the first time&#xD;
&#xD;
          -  Term,singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any inflammatory disease&#xD;
&#xD;
          -  Any pregnancy complication; IUGR,preeclampsia,preterm labor,preterm premature rupture&#xD;
             of membranes&#xD;
&#xD;
          -  Pregnancies &lt;37weeks gestational age&#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>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 24, 2016</last_update_submitted>
  <last_update_submitted_qc>November 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kayseri Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Hatice Akkaya</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <keyword>inflammatory reaction</keyword>
  <keyword>IL-6</keyword>
  <keyword>TNF</keyword>
  <keyword>Misgav Ladach technique</keyword>
  <keyword>Pfannenstiel-Kerr technique</keyword>
  <keyword>cesarean delivery</keyword>
  <keyword>cesarean technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>If needed</ipd_description>
  </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/NCT02976311
org study id: E52332816_51
nct id: NCT02976311
lead sponsor: 
has dmc: Yes
In this study, the investigators aimed to find out whether there are any differences in
      inflammatory reactions occured subsequent to two different cesarean delivery techniques;
      modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.
Cesarean section is one of the most undertaken operations in women of childbearing age.
      However, there is not a unique cesarean surgery technique. Pfannenstiel , reported his own
      technique in 1897. Because of the applicability of the technique, it went down well among
      obstetricians. After three decades, Kerr evolved this technique, and Pfannenstiel-Kerr
      technique became the method of choice until late 70's. In 1972, Stark et al defined the
      Misgav Ladach technique and in the following years this technique became popular among
      obstetricians. In late 80's Misgav Ladach technique was modified and started to be more
      popular. But, still Pfannenstiel-Kerr technique continued to be used frequently and studies
      comparing clinical outcomes of these two techniques were conducted for several times.
      However, the inflammatory responses which occured subsequent to application of these
      techniques were not investigated. This is the first study investigating the inflammatory
      response emerged after different cesarean surgery techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: IL-6
time frame: 24 hours
description: percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
measure: TNF-alpha
time frame: 24 hours
description: percentage of difference in serum IL-6 levels just before the beginning of the surgery and at the 24th hour of the surgery
arm group label: Misgav-Ladach
arm group type: Active Comparator
description: cesarean section(C/S) via the modified 'Misgav-Ladach' technique
arm group label: Pfannenstiel-Kerr
arm group type: Active Comparator
description: cesarean section(C/S) via the 'Pfannenstiel-Kerr' technique
intervention type: Procedure
intervention name: cesarean section(C/S) via the modified Misgav-Ladach technique
description: the first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique
arm group label: Misgav-Ladach
intervention type: Procedure
intervention name: cesarean section via the Pfannenstiel-Kerr technique
description: the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique
arm group label: Pfannenstiel-Kerr
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Hatice Akkaya
investigator title: doctor
mesh term: Inflammation
sharing ipd: Yes
ipd description: If needed