<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/NCT03267446</url>
  </required_header>
  <id_info>
    <org_study_id>CU28817</org_study_id>
    <nct_id>NCT03267446</nct_id>
  </id_info>
  <brief_title>Doppler Imaging and Morbidly Adherent Placenta</brief_title>
  <official_title>The Role of Grey Scale Ultrasound, 2D, and 3D Power Doppler in Diagnosing and Predicting the Surgical Risks in Patients With Morbidly Adherent Placenta.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic&#xD;
      technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta&#xD;
      as well as predict the surgical outcome regarding the type of surgery and the intra operative&#xD;
      morbidities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 29, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of 3D power Doppler in detecting morbidly adherent placenta.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Antepartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients confirmed having one or more of the signs of morbidly adherent placenta will be examined by 3D Ultrasound and 3D power Doppler. Patients will then be prepared for the operation.Cesarean hysterectomy will be done with removal of the uterus and the placenta as one mass.Cases with focal invasion of the uterus will be given a trial for conservative management. The whole specimen will be sent for histopathological examination, and the determination of length and depth of invasion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D Doppler Ultrasound</intervention_name>
    <description>3D volumes will be obtained in automatic sweeps using a motorized curved-array transducer while the women held their breath. In order to interpret the data consistently, the settings of power, On Voluson E10; GE Medical Systems)</description>
    <arm_group_label>Interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 - 45.&#xD;
&#xD;
          -  Pregnant 32 weeks or more.&#xD;
&#xD;
          -  Placenta previa (Major and Minor).&#xD;
&#xD;
          -  History of previous cesarean section.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical disorders such as bleeding disorders.&#xD;
&#xD;
          -  Lethal fetal anomalies.&#xD;
&#xD;
          -  Delivery before 34 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed M Hussein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo Univeristy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed M Hussein, MD</last_name>
    <phone>01223 515652</phone>
    <phone_ext>002</phone_ext>
    <email>ahmed_mhussein@live.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dina M Dakhly, MD</last_name>
    <phone>01003498919</phone>
    <phone_ext>002</phone_ext>
    <email>dinadakhly@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr el aini hospital</name>
      <address>
        <city>Cairo</city>
        <zip>12211</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed M Hussein, MD</last_name>
      <phone>01223515652</phone>
      <phone_ext>002</phone_ext>
      <email>ahmed_mhussein@live.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Mahmoud Hussein</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</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/NCT03267446
org study id: CU28817
nct id: NCT03267446
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic
      technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta
      as well as predict the surgical outcome regarding the type of surgery and the intra operative
      morbidities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity of 3D power Doppler in detecting morbidly adherent placenta.
time frame: 12 months
arm group label: Interventional group
arm group type: Experimental
description: Patients confirmed having one or more of the signs of morbidly adherent placenta will be examined by 3D Ultrasound and 3D power Doppler. Patients will then be prepared for the operation.Cesarean hysterectomy will be done with removal of the uterus and the placenta as one mass.Cases with focal invasion of the uterus will be given a trial for conservative management. The whole specimen will be sent for histopathological examination, and the determination of length and depth of invasion.
intervention type: Device
intervention name: 3D Doppler Ultrasound
description: 3D volumes will be obtained in automatic sweeps using a motorized curved-array transducer while the women held their breath. In order to interpret the data consistently, the settings of power, On Voluson E10; GE Medical Systems)
arm group label: Interventional group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed M Hussein, MD
role: Principal Investigator
affiliation: Cairo Univeristy
last name: Ahmed M Hussein, MD
phone: 01223 515652
phone ext: 002
email: ahmed_mhussein@live.com
last name: Dina M Dakhly, MD
phone: 01003498919
phone ext: 002
email: dinadakhly@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Mahmoud Hussein
investigator title: Assistant Professor
mesh term: Hemorrhage
sharing ipd: Undecided