<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/NCT03780699</url>
  </required_header>
  <id_info>
    <org_study_id>Ain Shams University H</org_study_id>
    <nct_id>NCT03780699</nct_id>
  </id_info>
  <brief_title>Hysteroscopic Evaluation of Cesarean Scar Defect</brief_title>
  <official_title>Hysteroscopic Evaluation of Cesarean Scar Defect Features &amp; Its Correlation With Women Complaints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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 aim of this study is to identify hysteroscopic findings of cesarean scar defect in women&#xD;
      underwent at least one prior cesarean section and its relation to any of the different un&#xD;
      explained gynecological presentations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</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>cesarean section scar defect shapes</measure>
    <time_frame>at least six months after CS</time_frame>
    <description>different shapes of CS defect and its relation to post menstrual spotting</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cesarean Scar Defect</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diagnostic hysteroscopic examination</intervention_name>
    <description>The hysteroscopic criteria of the cesarean scar defect will be observed with comment on different niche features</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be carried on 200 patients with cesarean scar defect recruited from Early&#xD;
        Cancer Detection Unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 and 35 years.&#xD;
&#xD;
          2. Had at least one prior cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of uterine surgery that could change the cavity anatomy.&#xD;
&#xD;
          2. Uterine Abnormalities as submucous fibroid, endometrial or endocervical Polyps.&#xD;
&#xD;
          3. Recent intra-uterine contraceptive device (IUCD) in place.&#xD;
&#xD;
          4. Known history of endometriosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Radwa R Ali, MD</last_name>
    <phone>01283492979</phone>
    <phone_ext>02002</phone_ext>
    <email>radwaebed@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>AinShams university maternity hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbassya</state>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Radwa R Ali, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Rasheedy Ali</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03780699
org study id: Ain Shams University H
nct id: NCT03780699
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to identify hysteroscopic findings of cesarean scar defect in women
      underwent at least one prior cesarean section and its relation to any of the different un
      explained gynecological presentations.
observational model: Other
time perspective: Cross-Sectional
measure: cesarean section scar defect shapes
time frame: at least six months after CS
description: different shapes of CS defect and its relation to post menstrual spotting
intervention type: Procedure
intervention name: Diagnostic hysteroscopic examination
description: The hysteroscopic criteria of the cesarean scar defect will be observed with comment on different niche features
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Radwa R Ali, MD
phone: 01283492979
phone ext: 02002
email: radwaebed@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Rasheedy Ali
investigator title: Principal Investigator
sharing ipd: No