<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/NCT03790371</url>
  </required_header>
  <id_info>
    <org_study_id>Ain Shams University MH</org_study_id>
    <nct_id>NCT03790371</nct_id>
  </id_info>
  <brief_title>Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion</brief_title>
  <official_title>Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion Following Previous Insertion Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      the current study was conducted to assess efficacy of vaginal misoprostol before IUD&#xD;
      insertion following previous insertion failure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">August 1, 2016</completion_date>
  <primary_completion_date type="Actual">August 1, 2016</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the success rate for IUD insertion.</measure>
    <time_frame>four hours after misoprostol dose</time_frame>
    <description>the success of IUD insertion after previous attempt failure</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>misoprostol group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>while the control group received a placebo tablet in the same regimen as the study group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>vaginal misoprostol prior IUD insertion</description>
    <arm_group_label>misoprostol group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>vaginal placebo tablet prior IUD insertion</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        One previous failed attempt of IUD insertion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Uterine fibroid distorting the cavity.&#xD;
&#xD;
          2. Anatomical uterine abnormality with distortion of the cavity&#xD;
&#xD;
          3. Current pelvic inflammatory disease or recently treated pelvic inflammatory disease&#xD;
             (PID) in the last three months.&#xD;
&#xD;
          4. Current purulent cervicitis (chlamydia or gonorrhea).&#xD;
&#xD;
          5. Immediately after septic abortion.&#xD;
&#xD;
          6. Uterus size less than 6 cm and more than 9 cm.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AinShams university maternity hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbassya</state>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Rasheedy Ali</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03790371
org study id: Ain Shams University MH
nct id: NCT03790371
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
the current study was conducted to assess efficacy of vaginal misoprostol before IUD
      insertion following previous insertion failure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: the success rate for IUD insertion.
time frame: four hours after misoprostol dose
description: the success of IUD insertion after previous attempt failure
arm group label: misoprostol group
arm group type: Active Comparator
description: misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion
arm group label: placebo
arm group type: Placebo Comparator
description: while the control group received a placebo tablet in the same regimen as the study group.
intervention type: Drug
intervention name: Misoprostol
description: vaginal misoprostol prior IUD insertion
arm group label: misoprostol group
intervention type: Drug
intervention name: Placebos
description: vaginal placebo tablet prior IUD insertion
arm group label: placebo
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 44 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Rasheedy Ali
investigator title: Principal Investigator
mesh term: Misoprostol