<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/NCT03016273</url>
  </required_header>
  <id_info>
    <org_study_id>BFCS</org_study_id>
    <nct_id>NCT03016273</nct_id>
  </id_info>
  <brief_title>Bladder Flap Technique In Elective Cesarean Section</brief_title>
  <official_title>Bladder Flap Versus Non Bladder Flap Technique In Women Undergoing Elective Cesarean Section A Randomized Controlled Trial</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>
      Cesarean section is a surgical procedure used to deliver one or more babies. cesarean section&#xD;
      is usually performed when vaginal delivery will put the mother or child's health or life at&#xD;
      risk. In recent years, the number of cesarean section has risen worldwide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the skin - delivery time</measure>
    <time_frame>duration of surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cesarean Delivery</condition>
  <arm_group>
    <arm_group_label>Bladder flap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The bladder flap is made by superficially incising and dissecting the peritoneal lining to separate the urinary bladder from the lower uterine segment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non bladder flap</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>creation of bladder flap</intervention_name>
    <description>Creation of the bladder flap, i.e., dissecting the urinary bladder from the lower segment of the uterus is a standard part of cesarean section (CS).</description>
    <arm_group_label>Bladder flap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing elective primary cesarean section&#xD;
&#xD;
          2. previous cesarean section&#xD;
&#xD;
          3. gestational age 32 or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing emergent cesarean section&#xD;
&#xD;
          2. Patients undergoing planned vertical uterine incision.&#xD;
&#xD;
          3. Patients undergone previous laparotomies.&#xD;
&#xD;
          4. Gestational age less than 32 weeks .&#xD;
&#xD;
          5. Patient refusing to participate in the study&#xD;
&#xD;
          6. Women with body mass index &gt;35&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yasmin Youssef, MBBCh</last_name>
    <phone>00201068248305</phone>
    <email>yasminalaa92@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tarek A. Farghaly, PHD</last_name>
    <phone>+20100 1338099</phone>
    <email>tarekabdelradi@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assuit university</name>
      <address>
        <city>Asyut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Abbas</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>July 3, 2017</last_update_submitted>
  <last_update_submitted_qc>July 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Yasmin mohamed Alaa eldin mahmoud Youssef</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <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/NCT03016273
org study id: BFCS
nct id: NCT03016273
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cesarean section is a surgical procedure used to deliver one or more babies. cesarean section
      is usually performed when vaginal delivery will put the mother or child's health or life at
      risk. In recent years, the number of cesarean section has risen worldwide.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: the skin - delivery time
time frame: duration of surgery
arm group label: Bladder flap
arm group type: Experimental
description: The bladder flap is made by superficially incising and dissecting the peritoneal lining to separate the urinary bladder from the lower uterine segment.
arm group label: Non bladder flap
arm group type: No Intervention
intervention type: Procedure
intervention name: creation of bladder flap
description: Creation of the bladder flap, i.e., dissecting the urinary bladder from the lower segment of the uterus is a standard part of cesarean section (CS).
arm group label: Bladder flap
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Yasmin Youssef, MBBCh
phone: 00201068248305
email: yasminalaa92@gmail.com
last name: Tarek A. Farghaly, PHD
phone: +20100 1338099
email: tarekabdelradi@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Yasmin mohamed Alaa eldin mahmoud Youssef
investigator title: Dr
sharing ipd: Undecided