<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/NCT03306953</url>
  </required_header>
  <id_info>
    <org_study_id>5678</org_study_id>
    <nct_id>NCT03306953</nct_id>
  </id_info>
  <brief_title>The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation</brief_title>
  <official_title>The Effect of Rectus Muscle Approximation at Cesarean Delivery on Postoperative Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective randomized controlled study to determine the clinical outcome of rectus&#xD;
      muscle re-approximation at Cesarean delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized controlled study to determine the clinical outcome of rectus&#xD;
      muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2&#xD;
      groups. Rectus muscle approximation will be done to the first group. The second group will be&#xD;
      the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">January 20, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Early pain score</measure>
    <time_frame>24 hours after cesarean section</time_frame>
    <description>Early pain score will be assessed by an investigator for patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Late pain score</measure>
    <time_frame>48 hours after cesarean section</time_frame>
    <description>Late pain score will be assessed by an investigator for patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Rectus muscle approximation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three sutures will be done for the the purpose of rectus muscle approximation in cesarean section.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No approximation for the rectus muscle will be done for the control group in cesarean section.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rectus muscle approximation</intervention_name>
    <description>The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.</description>
    <arm_group_label>Rectus muscle approximation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who will undergo first elective cesarean section&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous abdominal or pelvic surgery&#xD;
&#xD;
          -  Medical or psychiatric disease&#xD;
&#xD;
          -  Previous pelvic inflammatory disease&#xD;
&#xD;
          -  Obesity&#xD;
&#xD;
          -  Allergy to analgesics&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eman F Omran, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital</name>
      <address>
        <city>Cairo</city>
        <state>Greater Cairo</state>
        <zip>11956</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Eman Omran</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>Pain, Postoperative</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/NCT03306953
org study id: 5678
nct id: NCT03306953
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective randomized controlled study to determine the clinical outcome of rectus
      muscle re-approximation at Cesarean delivery.
This is a prospective randomized controlled study to determine the clinical outcome of rectus
      muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2
      groups. Rectus muscle approximation will be done to the first group. The second group will be
      the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Early pain score
time frame: 24 hours after cesarean section
description: Early pain score will be assessed by an investigator for patients
measure: Late pain score
time frame: 48 hours after cesarean section
description: Late pain score will be assessed by an investigator for patients
arm group label: Rectus muscle approximation
arm group type: Active Comparator
description: Three sutures will be done for the the purpose of rectus muscle approximation in cesarean section.
arm group label: Control
arm group type: No Intervention
description: No approximation for the rectus muscle will be done for the control group in cesarean section.
intervention type: Procedure
intervention name: Rectus muscle approximation
description: The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.
arm group label: Rectus muscle approximation
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: Eman F Omran, M.D.
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Eman Omran
investigator title: principal investigator
mesh term: Pain, Postoperative
sharing ipd: Undecided