<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/NCT03044093</url>
  </required_header>
  <id_info>
    <org_study_id>0299-16-RMB</org_study_id>
    <nct_id>NCT03044093</nct_id>
  </id_info>
  <brief_title>Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion</brief_title>
  <official_title>Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <brief_summary>
    <textblock>
      Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion -&#xD;
      a Double Blinded Randomized Controlled Trial&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in Hospital Stay Duration</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>number of days of hospital stay</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Second Trimester Abortion</condition>
  <arm_group>
    <arm_group_label>MISOPROSTOL alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the common practice currently in our medical center for second trimester medical abortion/ Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mifepristone and Misoprostol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in addition to the common practice currently in our medical center for second trimester medical abortion we will add Mifepristone before administering Misoprostol.&#xD;
Mifepristone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone</intervention_name>
    <description>The group that will get in addition to Misoprostol also Mifepristone</description>
    <arm_group_label>Mifepristone and Misoprostol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The group that will only get Misoprostol</description>
    <arm_group_label>MISOPROSTOL alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Both groups will get think drug</description>
    <arm_group_label>MISOPROSTOL alone</arm_group_label>
    <arm_group_label>Mifepristone and Misoprostol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  no allergy known to these drugs&#xD;
&#xD;
          -  second trimester abortion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hematology diseases&#xD;
&#xD;
          -  clotting factor deficiency&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>MEIR NIZRI, MD</last_name>
    <phone>972-50-2061521</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Rambam Medical Campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MEIR NIZRI, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Mifepristone</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/NCT03044093
org study id: 0299-16-RMB
nct id: NCT03044093
lead sponsor: 
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion -
      a Double Blinded Randomized Controlled Trial
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Reduction in Hospital Stay Duration
time frame: Up to 24 months
description: number of days of hospital stay
arm group label: MISOPROSTOL alone
arm group type: Active Comparator
description: the common practice currently in our medical center for second trimester medical abortion/ Placebo
arm group label: Mifepristone and Misoprostol
arm group type: Experimental
description: in addition to the common practice currently in our medical center for second trimester medical abortion we will add Mifepristone before administering Misoprostol.
Mifepristone
intervention type: Drug
intervention name: Mifepristone
description: The group that will get in addition to Misoprostol also Mifepristone
arm group label: Mifepristone and Misoprostol
intervention type: Drug
intervention name: Placebo
description: The group that will only get Misoprostol
arm group label: MISOPROSTOL alone
intervention type: Drug
intervention name: Misoprostol
description: Both groups will get think drug
arm group label: MISOPROSTOL alone
arm group label: Mifepristone and Misoprostol
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: MEIR NIZRI, MD
phone: 972-50-2061521
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Misoprostol
mesh term: Mifepristone
sharing ipd: No