<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/NCT02989324</url>
  </required_header>
  <id_info>
    <org_study_id>zuh- 4</org_study_id>
    <nct_id>NCT02989324</nct_id>
  </id_info>
  <brief_title>Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy</brief_title>
  <official_title>Low Dose Vaginal Misoprostol With or Without Foley Catheter for Late Second Trimester Pregnancy Termination in Women With Previous Multiple Cesarean Sections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second&#xD;
      Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus&#xD;
      Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple&#xD;
      Cesarean Sections to assess safety and efficacy of theses methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>induction to expulsion interval</measure>
    <time_frame>24 hours</time_frame>
    <description>from time to start induction to time of complete expulsion of product of conception</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Late Second Trimester Termination of Pregnancy</condition>
  <arm_group>
    <arm_group_label>Vaginal Misoprosto</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol Plus Foley Catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MisoprostoL</intervention_name>
    <description>Vaginal MisoprostoL</description>
    <arm_group_label>Misoprostol Plus Foley Catheter</arm_group_label>
    <arm_group_label>Vaginal Misoprosto</arm_group_label>
    <other_name>CYTOTEC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Foley Catheter</intervention_name>
    <description>Misoprostol Plus Foley Catheter</description>
    <arm_group_label>Misoprostol Plus Foley Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:late second trimester&#xD;
&#xD;
          -  IUFD&#xD;
&#xD;
          -  Previous Multiple Cesarean Sections&#xD;
&#xD;
        Exclusion Criteria:Low lying placenta&#xD;
&#xD;
          -  asthma&#xD;
&#xD;
          -  allergy to misoprostol&#xD;
&#xD;
          -  patient refuse to participate&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ibrahim A el sharkwy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>IBRAHIM ABD ELGAFOR</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_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/NCT02989324
org study id: zuh- 4
nct id: NCT02989324
lead sponsor: 
has dmc: Yes
Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second
      Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections
this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus
      Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple
      Cesarean Sections to assess safety and efficacy of theses methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: induction to expulsion interval
time frame: 24 hours
description: from time to start induction to time of complete expulsion of product of conception
arm group label: Vaginal Misoprosto
arm group type: Experimental
description: Vaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section
arm group label: Misoprostol Plus Foley Catheter
arm group type: Active Comparator
description: Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections
intervention type: Drug
intervention name: MisoprostoL
description: Vaginal MisoprostoL
arm group label: Misoprostol Plus Foley Catheter
arm group label: Vaginal Misoprosto
other name: CYTOTEC
intervention type: Device
intervention name: Foley Catheter
description: Misoprostol Plus Foley Catheter
arm group label: Misoprostol Plus Foley Catheter
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ibrahim A el sharkwy, MD
role: Principal Investigator
affiliation: FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: IBRAHIM ABD ELGAFOR
investigator title: assistant professor
mesh term: Misoprostol
sharing ipd: No