<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/NCT02235155</url>
  </required_header>
  <id_info>
    <org_study_id>1017</org_study_id>
    <nct_id>NCT02235155</nct_id>
  </id_info>
  <brief_title>Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan</brief_title>
  <official_title>Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Uzbekistan</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol&#xD;
      medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of abortions that are complete as a measure of efficacy</measure>
    <time_frame>At 15 hours after the start of misoprostol administration</time_frame>
    <description>It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interval of time between induction with misoprostol to complete abortion</measure>
    <time_frame>Every 3 hours from the start of misoprostol administration until complete abortion</time_frame>
    <description>It is the length of time between the administration of the first dose of misoprostol and complete abortion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Women's satisfaction with the method</measure>
    <time_frame>At discharge, up to 5 days after enrollment</time_frame>
    <description>It is a scale that assesses the level of a woman's satisfaction with the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects experienced by women</measure>
    <time_frame>Every 3 hours from the start of misoprostol administration until complete abortion</time_frame>
    <description>It is a brief questionnaire that records all side effects experienced by women.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain experienced by women</measure>
    <time_frame>At the time of discharge, up to 5 days after enrollment</time_frame>
    <description>It is a scale that assesses the acceptability of pain experienced by the woman.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications during induction and after discharge</measure>
    <time_frame>Every 3 hours from the start of misoprostol administration, up to 1 month after discharge</time_frame>
    <description>It is a record of complications and their treatment during induction and up to 1 month after discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Women's perception of acceptability of the procedure</measure>
    <time_frame>At discharge, up to 5 days after enrollment</time_frame>
    <description>It is a scale that assesses the acceptability of the procedure for the woman.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider's perception of acceptability of the method</measure>
    <time_frame>At study completion, up to 2 years after study enrollment commences</time_frame>
    <description>It is a questionnaire that assesses the acceptability of the method for the provider.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total dose of misoprostol administered</measure>
    <time_frame>Every 3 hours from start of misoprostol administration to complete abortion</time_frame>
    <description>Count of the total dose of misoprostol administered from the first dose to complete abortion.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">135</enrollment>
  <condition>Abortion in Second Trimester</condition>
  <arm_group>
    <arm_group_label>Pregnant women of 13-22 weeks gestation</arm_group_label>
    <description>Pregnant women of 13-22 weeks gestation will receive 200 mg mifepristone followed 24-48 hours later by 400 mcg sublingual misoprostol every three hours until complete expulsion.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet legal criteria to obtain abortion&#xD;
&#xD;
          -  Have an ongoing pregnancy of 13-22 weeks gestation&#xD;
&#xD;
          -  Be willing to undergo a surgical completion if necessary&#xD;
&#xD;
          -  Have no contraindications to study procedures, according to provider&#xD;
&#xD;
          -  Be willing and able to consent to procedure, either by reading consent document or by&#xD;
             having consent document read to her&#xD;
&#xD;
          -  Be willing to follow study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known previous transmural uterine incision&#xD;
&#xD;
          -  Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications&#xD;
             to the use of mifepristone or misoprostol&#xD;
&#xD;
          -  Any contraindications to vaginal delivery, including placenta previa&#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>Dilfuza Kurbanbekova, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women's Wellness Center, Uzbekistan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tamar Tsereteli, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Beverly Winikoff, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynuity Health Projects</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bukhara Maternity House No. 1</name>
      <address>
        <city>Bukhara</city>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samarkand Perinatal Center</name>
      <address>
        <city>Samarkand</city>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic No. 2, Tashkent Medical Academy</name>
      <address>
        <city>Tashkent</city>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uzbekistan</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>January 13, 2016</last_update_submitted>
  <last_update_submitted_qc>January 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02235155
org study id: 1017
nct id: NCT02235155
lead sponsor: 
has dmc: No
The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol
      medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.
observational model: Cohort
time perspective: Prospective
measure: Proportion of abortions that are complete as a measure of efficacy
time frame: At 15 hours after the start of misoprostol administration
description: It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration.
measure: Interval of time between induction with misoprostol to complete abortion
time frame: Every 3 hours from the start of misoprostol administration until complete abortion
description: It is the length of time between the administration of the first dose of misoprostol and complete abortion.
measure: Women's satisfaction with the method
time frame: At discharge, up to 5 days after enrollment
description: It is a scale that assesses the level of a woman's satisfaction with the procedure.
measure: Side effects experienced by women
time frame: Every 3 hours from the start of misoprostol administration until complete abortion
description: It is a brief questionnaire that records all side effects experienced by women.
measure: Pain experienced by women
time frame: At the time of discharge, up to 5 days after enrollment
description: It is a scale that assesses the acceptability of pain experienced by the woman.
measure: Complications during induction and after discharge
time frame: Every 3 hours from the start of misoprostol administration, up to 1 month after discharge
description: It is a record of complications and their treatment during induction and up to 1 month after discharge.
measure: Women's perception of acceptability of the procedure
time frame: At discharge, up to 5 days after enrollment
description: It is a scale that assesses the acceptability of the procedure for the woman.
measure: Provider's perception of acceptability of the method
time frame: At study completion, up to 2 years after study enrollment commences
description: It is a questionnaire that assesses the acceptability of the method for the provider.
measure: Total dose of misoprostol administered
time frame: Every 3 hours from start of misoprostol administration to complete abortion
description: Count of the total dose of misoprostol administered from the first dose to complete abortion.
arm group label: Pregnant women of 13-22 weeks gestation
description: Pregnant women of 13-22 weeks gestation will receive 200 mg mifepristone followed 24-48 hours later by 400 mcg sublingual misoprostol every three hours until complete expulsion.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dilfuza Kurbanbekova, PhD, MD
role: Principal Investigator
affiliation: Women's Wellness Center, Uzbekistan
last name: Tamar Tsereteli, PhD, MD
role: Principal Investigator
affiliation: Gynuity Health Projects
last name: Beverly Winikoff, MD, MPH
role: Principal Investigator
affiliation: Gynuity Health Projects
facility: 
facility: 
facility: 
country: Uzbekistan
responsible party type: Sponsor