<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/NCT03820089</url>
  </required_header>
  <id_info>
    <org_study_id>prolapse</org_study_id>
    <nct_id>NCT03820089</nct_id>
  </id_info>
  <brief_title>Evaluation of TP US in Women With Prolapse</brief_title>
  <official_title>Evaluation of TP US Assesment of Women With Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aljazeera Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms&#xD;
      in menopause&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most common cause of pelvic organ prolapse is multiple pregnancy and multiparity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">January 25, 2020</completion_date>
  <primary_completion_date type="Actual">January 20, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>8 Weeks</target_duration>
  <primary_outcome>
    <measure>The number of women who will be properly diagnosed with prolapse by TP us</measure>
    <time_frame>within 2 months</time_frame>
    <description>The accuracy of TP US in diagnosing the prolapse</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Prolapse</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasonography TP</intervention_name>
    <description>TP us will be made to the included women</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who complains from genital prolapse with previous normal deliveries&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with history of normal delivery Age between 25 to 75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with cesarean deliveries&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Females who have pelvic organ prolapse</gender_description>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Alalfy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algazeerah and Kasralainy hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
  </condition_browse>
  <!-- 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/NCT03820089
org study id: prolapse
nct id: NCT03820089
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms
      in menopause
The most common cause of pelvic organ prolapse is multiple pregnancy and multiparity
observational model: Cohort
time perspective: Prospective
measure: The number of women who will be properly diagnosed with prolapse by TP us
time frame: within 2 months
description: The accuracy of TP US in diagnosing the prolapse
intervention type: Diagnostic Test
intervention name: Ultrasonography TP
description: TP us will be made to the included women
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Females who have pelvic organ prolapse
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Alalfy, PhD
role: Principal Investigator
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Prolapse