<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/NCT03800511</url>
  </required_header>
  <id_info>
    <org_study_id>Prediction of intra-abdominal</org_study_id>
    <nct_id>NCT03800511</nct_id>
  </id_info>
  <brief_title>Prediction of Intra-abdominal Adhesion Before CS</brief_title>
  <official_title>Prediction of Intra-abdominal Adhesion Before CS: A Diagnostic Test Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nahed allam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar 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>
      Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for&#xD;
      the surgeon and patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the repeated cesarean section is associated with recorded maternal morbidity including&#xD;
      placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular&#xD;
      injuries. The anticipation of the problem is important for decreasing its adverse effect .&#xD;
      preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall,&#xD;
      bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior&#xD;
      staff obstetrician or others and theatre requirements to overcome any problem happened.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>intra-abdominal adhesion</measure>
    <time_frame>intra-operative period</time_frame>
    <description>presence of adhesion between uterus and abdominal wall or intestine on bladder</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>skin to uterine incision time</measure>
    <time_frame>intra-operative period</time_frame>
    <description>time consumed by surgeon from skin incision to uterine incision in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need to insert intra-peritoneal drain</measure>
    <time_frame>intraoperative period</time_frame>
    <description>if there in marked adhesion and vascular injury a drain could be inserted</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">27</enrollment>
  <condition>Intra-Abdominal; Adhesion</condition>
  <arm_group>
    <arm_group_label>repeated caesarean section</arm_group_label>
    <description>full term pregnant women with singleton baby with a history of at least previous one caesarean section</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>sliding test</intervention_name>
    <description>ultrasound detected sliding test before doing repeated caesarean section</description>
    <arm_group_label>repeated caesarean section</arm_group_label>
    <other_name>ultrasound detected sliding test</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women in their 9th-month singleton planned for elective repeated CS and had a&#xD;
        history of previous CS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant in their 9th-month singleton, planned for elective CS and had a history of&#xD;
             previous CS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  included multiple pregnancies, preterm labour, emergency CS, skin burn at the site of&#xD;
             CS&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taiseer Maarouf, MD</last_name>
    <role>Study Chair</role>
    <affiliation>ALAZHAR UNIVERSITY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>nahed allam, MD</last_name>
    <phone>+0201121116136</phone>
    <email>nahedallam16@gmail.com</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Nahed allam</investigator_full_name>
    <investigator_title>Proffesor Nahed Ezzat Allam (Nallam</investigator_title>
  </responsible_party>
  <keyword>sliding test , ceaserean section</keyword>
  <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>Undecided</sharing_ipd>
    <ipd_description>It is not yet known if there will be a plan to make IPD available.discussion with the other authors after completion of recruitment of patients</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/NCT03800511
org study id: Prediction of intra-abdominal
nct id: NCT03800511
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Recognition of intraabdominal adhesion before doing repeated cesarean section is helpful for
      the surgeon and patients.
the repeated cesarean section is associated with recorded maternal morbidity including
      placenta preavia and accreta , liability to injuries to the bladder, intestine or vascular
      injuries. The anticipation of the problem is important for decreasing its adverse effect .
      preoperative diagnosis of pelvic adhesion between the uterus and anterior abdominal wall,
      bladder, intestine or omentum could b of help to give time for a surgeon to prepare senior
      staff obstetrician or others and theatre requirements to overcome any problem happened.
observational model: Case-Only
time perspective: Prospective
measure: intra-abdominal adhesion
time frame: intra-operative period
description: presence of adhesion between uterus and abdominal wall or intestine on bladder
measure: skin to uterine incision time
time frame: intra-operative period
description: time consumed by surgeon from skin incision to uterine incision in minutes
measure: need to insert intra-peritoneal drain
time frame: intraoperative period
description: if there in marked adhesion and vascular injury a drain could be inserted
arm group label: repeated caesarean section
description: full term pregnant women with singleton baby with a history of at least previous one caesarean section
intervention type: Diagnostic Test
intervention name: sliding test
description: ultrasound detected sliding test before doing repeated caesarean section
arm group label: repeated caesarean section
other name: ultrasound detected sliding test
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: No
last name: Taiseer Maarouf, MD
role: Study Chair
affiliation: ALAZHAR UNIVERSITY
last name: nahed allam, MD
phone: +0201121116136
email: nahedallam16@gmail.com
responsible party type: Sponsor-Investigator
investigator affiliation: Al-Azhar University
investigator full name: Nahed allam
investigator title: Proffesor Nahed Ezzat Allam (Nallam
mesh term: Tissue Adhesions
sharing ipd: Undecided
ipd description: It is not yet known if there will be a plan to make IPD available.discussion with the other authors after completion of recruitment of patients