<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/NCT03792438</url>
  </required_header>
  <id_info>
    <org_study_id>Hesham Mohamed Elnaggar</org_study_id>
    <nct_id>NCT03792438</nct_id>
  </id_info>
  <brief_title>Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound</brief_title>
  <official_title>Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</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>
      This study aims to assess the relation between the vascularity of uterine septum and&#xD;
      obstetric performance with Transvaginal 3D Power Doppler Ultrasound&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research hypothesis:&#xD;
&#xD;
      In women with uterine septum vascularity of the septum may affect obstetric performance.&#xD;
&#xD;
      Research question:&#xD;
&#xD;
      In women with uterine septum does vascularity of the septum affect obstetric outcome?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2017</start_date>
  <completion_date type="Actual">November 25, 2018</completion_date>
  <primary_completion_date type="Actual">November 25, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium</measure>
    <time_frame>About 18 months</time_frame>
    <description>Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium and its relationship to either primary infertility or recurrent abortion</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Septum; Uterus</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transvaginal 3D Power Doppler Ultrasound</intervention_name>
    <description>Samsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with primary infertility or recurrent abortion attending to Early Cancer Detection&#xD;
        Unit at Ain Shams Maternity Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with septate uterus diagnosed by office hysteroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with previous uterine scar.&#xD;
&#xD;
          -  Women with suspected or confirmed pregnancy.&#xD;
&#xD;
          -  Women with active pelvic infection or old one.&#xD;
&#xD;
          -  Women with abnormal uterine bleeding.&#xD;
&#xD;
          -  Fibroids, adenomyosis or ovarian swelling.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed I Amer, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nashwa E Hassan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mortada E Ahmed, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11357</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>Hesham Mohamed Mohamed Elnaggar</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>Septate Uterus</mesh_term>
  </condition_browse>
  <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/NCT03792438
org study id: Hesham Mohamed Elnaggar
nct id: NCT03792438
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the relation between the vascularity of uterine septum and
      obstetric performance with Transvaginal 3D Power Doppler Ultrasound
Research hypothesis:

      In women with uterine septum vascularity of the septum may affect obstetric performance.

      Research question:

      In women with uterine septum does vascularity of the septum affect obstetric outcome?
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium
time frame: About 18 months
description: Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium and its relationship to either primary infertility or recurrent abortion
intervention type: Diagnostic Test
intervention name: Transvaginal 3D Power Doppler Ultrasound
description: Samsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Mohamed I Amer, MD
role: Study Chair
affiliation: Professor
last name: Nashwa E Hassan, MD
role: Study Director
affiliation: Assistant Professor
last name: Mortada E Ahmed, MD
role: Study Director
affiliation: Lecturer
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: Hesham Mohamed Mohamed Elnaggar
investigator title: Principal Investigator
mesh term: Septate Uterus
sharing ipd: No