<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/NCT03813849</url>
  </required_header>
  <id_info>
    <org_study_id>0409/016</org_study_id>
    <nct_id>NCT03813849</nct_id>
  </id_info>
  <brief_title>Remnants of Conception After Suction Evacuation of Missed Abortion</brief_title>
  <official_title>Sonographic Detection of Remnants After Surgical Evacuation of Missed Abortion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alexandria</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>
      All women admitted for surgical evacuation of missed abortion after failure of medical&#xD;
      treatment from June 2016 underwent transvaginal sonography immediately after completion of&#xD;
      the procedure as judged by the operator to ensure absence of remnants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women indicated for surgical evacuation of missed abortion up to 12 weeks were included.&#xD;
      Standard surgical evacuation of uterus by suction followed by sharp curettage under general&#xD;
      anaesthesia were done for all cases. When the operator judged the procedure as complete,&#xD;
      transvaginal sonography was done by dedicated sonographer using portable ultrasound machine&#xD;
      in theatre. If remnants were detected the procedure was repeated till the cavity seen empty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 10, 2016</start_date>
  <completion_date type="Anticipated">March 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2020</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>presence remnants of conception</measure>
    <time_frame>immediately after the end of the procedure</time_frame>
    <description>transvaginal sonographic detection</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Miscarriage</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sonographic examination of uterus after surgical evacuation</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        multiparous women, aged 18 to 45 years with missed abortion up to 12 weeks gestational age,&#xD;
        with normal uterus and without suspicion of sepsis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        multiparous. have missed abortion up to 12 weeks gestational age by dating. failed medical&#xD;
        evacuation. consented for the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        suspicion of sepsis. Suspected molar pregnancy. previous evacuation trial. abnormal uterus&#xD;
        like fibroids.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mervat S Omran, M.D</last_name>
    <phone>+2034226106</phone>
    <email>Mervat.Elsedeek@alexmed.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shatby maternity university hospital</name>
      <address>
        <city>Alexandria</city>
        <zip>03312</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mervat S Omran, M.D</last_name>
      <phone>1005277168</phone>
      <email>Mervat.Elsedeek@alexmed.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>April 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>October 25, 2019</last_update_submitted>
  <last_update_submitted_qc>October 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Mervat Sheikhelarab Elsedeek Ibrahim Omran</investigator_full_name>
    <investigator_title>professor of obstetrics and gynecology</investigator_title>
  </responsible_party>
  <keyword>remnants of conception</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Abortion, Missed</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/NCT03813849
org study id: 0409/016
nct id: NCT03813849
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
All women admitted for surgical evacuation of missed abortion after failure of medical
      treatment from June 2016 underwent transvaginal sonography immediately after completion of
      the procedure as judged by the operator to ensure absence of remnants.
Women indicated for surgical evacuation of missed abortion up to 12 weeks were included.
      Standard surgical evacuation of uterus by suction followed by sharp curettage under general
      anaesthesia were done for all cases. When the operator judged the procedure as complete,
      transvaginal sonography was done by dedicated sonographer using portable ultrasound machine
      in theatre. If remnants were detected the procedure was repeated till the cavity seen empty.
observational model: Case-Only
time perspective: Prospective
measure: presence remnants of conception
time frame: immediately after the end of the procedure
description: transvaginal sonographic detection
intervention type: Diagnostic Test
intervention name: Sonographic examination of uterus after surgical evacuation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mervat S Omran, M.D
phone: +2034226106
email: Mervat.Elsedeek@alexmed.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: University of Alexandria
investigator full name: Mervat Sheikhelarab Elsedeek Ibrahim Omran
investigator title: professor of obstetrics and gynecology
mesh term: Abortion, Spontaneous
mesh term: Abortion, Missed
sharing ipd: Undecided