<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/NCT01716091</url>
  </required_header>
  <id_info>
    <org_study_id>Aşıcıoğlu 02</org_study_id>
    <nct_id>NCT01716091</nct_id>
  </id_info>
  <brief_title>The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery</brief_title>
  <official_title>The Effect of Saline Irrigation in the Peritoneal Cavity at Cesarean Delivery on Maternal Morbidity and Gastrointestinal System Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Bakirkoy Maternity and Children Diseases Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Bakirkoy Maternity and Children Diseases Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypotheised that irrigating the abdominal cavity with saline at the time of&#xD;
      cesarean delivery will increase Gastrointestinal System Disfunction without maternal&#xD;
      infectious morbidity(especially febril morbidity).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">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>postoperative gastrointestinal system disturbance</measure>
    <time_frame>postoperativeone weeks</time_frame>
    <description>ıntraoperative and postoperative nausea,emesiz and requirement antıemetic drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative febril morbidity</measure>
    <time_frame>postoperative six weeks</time_frame>
    <description>postoperative endometritis,febril morbidity</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">430</enrollment>
  <condition>Postoperative Enfectious Morbidity</condition>
  <condition>Postoperative GİS Functionally Recovery</condition>
  <arm_group>
    <arm_group_label>saline irrigation</arm_group_label>
    <description>irrigation group:saline irrigation after uterine wall closed control group:no irrigation after uterine wall closed</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>irrigation in the peritoneal cavity</intervention_name>
    <description>irrigation in the peritoneal cavity after uterine wall closed at cesarean</description>
    <arm_group_label>saline irrigation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all pregnant women between 18 years or older and who requıred cesarean delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Elective cesarean delivery&#xD;
&#xD;
          2. Gestational age greater 38 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. chorioamnıonıtıs&#xD;
&#xD;
          2. type 1 diabetes mellitus&#xD;
&#xD;
          3. placenta previa and acreata&#xD;
&#xD;
          4. prior severe gastrointestional disease&#xD;
&#xD;
          5. emergency cesarean delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Osman Aşıcıoğlu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>T.C. Kanuni Sultan Süleyman Teaching Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>T.C. Kanuni Sultan Süleyman Teaching Hospital</name>
      <address>
        <city>Halkalı/İstanbul</city>
        <state>Küçükçekmece</state>
        <zip>34105</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>January 6, 2015</last_update_submitted>
  <last_update_submitted_qc>January 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Bakirkoy Maternity and Children Diseases Hospital</investigator_affiliation>
    <investigator_full_name>Osman Aşıcıoğlu</investigator_full_name>
    <investigator_title>T.C. Şişli Etfal E A H</investigator_title>
  </responsible_party>
  <keyword>focus of study is postoperative enfectious morbidity and postoperative GİS functionally recovery</keyword>
  <!-- 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/NCT01716091
org study id: Aşıcıoğlu 02
nct id: NCT01716091
lead sponsor: 
has dmc: No
The investigators hypotheised that irrigating the abdominal cavity with saline at the time of
      cesarean delivery will increase Gastrointestinal System Disfunction without maternal
      infectious morbidity(especially febril morbidity).
observational model: Case-Control
time perspective: Prospective
measure: postoperative gastrointestinal system disturbance
time frame: postoperativeone weeks
description: ıntraoperative and postoperative nausea,emesiz and requirement antıemetic drug
measure: postoperative febril morbidity
time frame: postoperative six weeks
description: postoperative endometritis,febril morbidity
arm group label: saline irrigation
description: irrigation group:saline irrigation after uterine wall closed control group:no irrigation after uterine wall closed
intervention type: Procedure
intervention name: irrigation in the peritoneal cavity
description: irrigation in the peritoneal cavity after uterine wall closed at cesarean
arm group label: saline irrigation
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Osman Aşıcıoğlu, M.D.
role: Principal Investigator
affiliation: T.C. Kanuni Sultan Süleyman Teaching Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Bakirkoy Maternity and Children Diseases Hospital
investigator full name: Osman Aşıcıoğlu
investigator title: T.C. Şişli Etfal E A H