<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/NCT03261765</url>
  </required_header>
  <id_info>
    <org_study_id>CSIAA</org_study_id>
    <nct_id>NCT03261765</nct_id>
  </id_info>
  <brief_title>Effect of Multiple Repeat Cesarean Sections on Intra-abdominal Adhesions</brief_title>
  <official_title>Effect of Multiple Repeat Cesarean Sections on Intra-abdominal Adhesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</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 rate of cesarean section deliveries has increased dramatically worldwide in the last&#xD;
      decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to&#xD;
      2007 data and is thought to be over 50% at present. The reasons for this include advanced age&#xD;
      of primigravida, a wide range of indications, patient requests, the frequency of women with&#xD;
      previous cesareans, women's rejections to offers of sterilization, and the common usage of&#xD;
      assisted reproductive techniques&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of abdominal adhesions</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>Multiple repeat cesarean (four or more)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Fewer repeat cesarean (two-three)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of adhesions</intervention_name>
    <description>Modified Nair scoring system</description>
    <arm_group_label>Fewer repeat cesarean (two-three)</arm_group_label>
    <arm_group_label>Multiple repeat cesarean (four or more)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All women with repeated cesarean section&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women with at least previous one cesarean section.&#xD;
&#xD;
          2. Women accepted to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous abdominopelvic surgery other than cesarean section.&#xD;
&#xD;
          2. History of Pelvic inflammatory disease.&#xD;
&#xD;
          3. Women refuse to participate in the study.&#xD;
&#xD;
          4. Intrauterine fetal death&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed Abbas</last_name>
    <phone>01003385183</phone>
    <email>bmr90@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Abbas</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ahmed Abbas</name>
      <address>
        <city>Assiut</city>
        <state>Cairo</state>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ahmed abbas</last_name>
      <email>bmr90@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>June 26, 2018</last_update_submitted>
  <last_update_submitted_qc>June 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abbas</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Adhesions</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/NCT03261765
org study id: CSIAA
nct id: NCT03261765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The rate of cesarean section deliveries has increased dramatically worldwide in the last
      decades. While the cesarean birth rate was 4.5% in the USA in 1965, it was 31.8% according to
      2007 data and is thought to be over 50% at present. The reasons for this include advanced age
      of primigravida, a wide range of indications, patient requests, the frequency of women with
      previous cesareans, women's rejections to offers of sterilization, and the common usage of
      assisted reproductive techniques
observational model: Other
time perspective: Cross-Sectional
measure: Rate of abdominal adhesions
time frame: 30 minutes
arm group label: Multiple repeat cesarean (four or more)
arm group label: Fewer repeat cesarean (two-three)
intervention type: Other
intervention name: Assessment of adhesions
description: Modified Nair scoring system
arm group label: Fewer repeat cesarean (two-three)
arm group label: Multiple repeat cesarean (four or more)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Ahmed Abbas
phone: 01003385183
email: bmr90@hotmail.com
last name: Ahmed Abbas
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: principal investigator
mesh term: Tissue Adhesions
sharing ipd: No