<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/NCT03269279</url>
  </required_header>
  <id_info>
    <org_study_id>1036</org_study_id>
    <nct_id>NCT03269279</nct_id>
  </id_info>
  <brief_title>Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso</brief_title>
  <official_title>Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gynuity Health Projects</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gynuity Health Projects</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 goal of this study is to examine the effectiveness and feasibility of a&#xD;
      mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in&#xD;
      Burkina Faso.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 20, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of successful abortion</measure>
    <time_frame>24 hours</time_frame>
    <description>Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Medical; Abortion, Fetus</condition>
  <arm_group>
    <arm_group_label>Medical abortion arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone</intervention_name>
    <description>Medication used in conjunction with misoprostol for abortion</description>
    <arm_group_label>Medical abortion arm</arm_group_label>
    <other_name>Medabon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Medication used in conjunction with mifepristone for abortion</description>
    <arm_group_label>Medical abortion arm</arm_group_label>
    <other_name>Misoclear</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having an ongoing pregnancy of 13-22 weeks gestation&#xD;
&#xD;
          -  Be willing to undergo surgical completion if necessary&#xD;
&#xD;
          -  Have no contraindications to study procedures, according to provider&#xD;
&#xD;
          -  Be willing and able to consent to participate in the study&#xD;
&#xD;
          -  Be willing to follow study procedures&#xD;
&#xD;
          -  Respect legal indications for obtaining an abortion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to mifepristone or misoprostol/prostaglandin&#xD;
&#xD;
          -  Any contraindications to vaginal delivery, including placenta previa&#xD;
&#xD;
          -  Previous transmural uterine incsion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Blandine Thieba, MD</last_name>
    <role>Study Director</role>
    <affiliation>SOGOB</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Evelyne Komboigo, MD</last_name>
    <role>Study Chair</role>
    <affiliation>SOGOB</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Meighan Tarnagada, MPH</last_name>
    <phone>212.448.1230</phone>
    <email>mtarnagada@gynuity.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ayisha Diop, MS</last_name>
    <phone>212.448.1230</phone>
    <email>adiop@gynuity.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHUSS</name>
      <address>
        <city>Bobo-Dioulasso</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evelyne Komboigo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CMA Boromo</name>
      <address>
        <city>Boromo</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evelyne Komboigo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHUYO</name>
      <address>
        <city>Ouagadougou</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evelyne Komboigo, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHR Ouahigouya</name>
      <address>
        <city>Ouahigouya</city>
        <country>Burkina Faso</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evelyne Komboigo, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Burkina Faso</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>May 28, 2019</last_update_submitted>
  <last_update_submitted_qc>May 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2019</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/NCT03269279
org study id: 1036
nct id: NCT03269279
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to examine the effectiveness and feasibility of a
      mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in
      Burkina Faso.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of successful abortion
time frame: 24 hours
description: Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol
arm group label: Medical abortion arm
arm group type: Experimental
description: 200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester
intervention type: Drug
intervention name: Mifepristone
description: Medication used in conjunction with misoprostol for abortion
arm group label: Medical abortion arm
other name: Medabon
intervention type: Drug
intervention name: Misoprostol
description: Medication used in conjunction with mifepristone for abortion
arm group label: Medical abortion arm
other name: Misoclear
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Blandine Thieba, MD
role: Study Director
affiliation: SOGOB
last name: Evelyne Komboigo, MD
role: Study Chair
affiliation: SOGOB
last name: Meighan Tarnagada, MPH
phone: 212.448.1230
email: mtarnagada@gynuity.org
last name: Ayisha Diop, MS
phone: 212.448.1230
email: adiop@gynuity.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Burkina Faso
responsible party type: Sponsor
mesh term: Misoprostol
mesh term: Mifepristone
sharing ipd: No