<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/NCT04505943</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/352/5/19</org_study_id>
    <nct_id>NCT04505943</nct_id>
  </id_info>
  <brief_title>Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion</brief_title>
  <official_title>Comparison of Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</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>
      To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic&#xD;
      Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing&#xD;
      IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Long-acting reversible contraception methods are highly effective methods for reduction of&#xD;
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that&#xD;
      provides reliable, effective and long term contraception for many women. However, the&#xD;
      insertion procedure can be associated with a troublesome degree of pain that prevent some&#xD;
      women from choosing its use. Different interventions have been described to decrease pain&#xD;
      perception during intrauterine device insertion with no agreement on an effective one.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2021</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>randomized controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in visual analog scale pain scores during intrauterine device insertion</measure>
    <time_frame>10 minuts</time_frame>
    <description>The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the difference in visual analog scale pain scores during tenaculum application</measure>
    <time_frame>10 minuts</time_frame>
    <description>The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the ease of IUD insertion</measure>
    <time_frame>10 minutes</time_frame>
    <description>the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>women's satisfaction level: score</measure>
    <time_frame>10 minutes</time_frame>
    <description>women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>IUCD Complication</condition>
  <arm_group>
    <arm_group_label>isonicotinic acid hydrazide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dinoprostone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia &amp; Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>misoprostol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 12hours before IUD insertion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isonicotinic Acid Hydrazide</intervention_name>
    <description>2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.</description>
    <arm_group_label>isonicotinic acid hydrazide</arm_group_label>
    <other_name>INH</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dinoprostine</intervention_name>
    <description>2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia &amp; Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.</description>
    <arm_group_label>dinoprostone</arm_group_label>
    <other_name>prostin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>misoprostol</intervention_name>
    <description>2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion</description>
    <arm_group_label>misoprostol</arm_group_label>
    <other_name>Misotac</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nulliparous women requesting copper IUD insertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  Parous women,&#xD;
&#xD;
          -  contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD&#xD;
             insertion,&#xD;
&#xD;
          -  untreated active cervicitis or vaginitis,&#xD;
&#xD;
          -  undiagnosed abnormal uterine bleeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>nulliparous women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nahla w Shady, md</last_name>
    <role>Study Chair</role>
    <affiliation>Aswan universirty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hany f Sallam, md</last_name>
    <phone>+20102435461</phone>
    <phone_ext>002</phone_ext>
    <email>hany.farouk@aswu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>nahla w Shady, md</last_name>
    <phone>+201022336052</phone>
    <phone_ext>002</phone_ext>
    <email>hanygyne@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aswan University Hospital</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 15, 2020</last_update_submitted>
  <last_update_submitted_qc>August 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>A Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isoniazid</mesh_term>
    <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/NCT04505943
org study id: aswu/352/5/19
nct id: NCT04505943
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic
      Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing
      IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.
Long-acting reversible contraception methods are highly effective methods for reduction of
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that
      provides reliable, effective and long term contraception for many women. However, the
      insertion procedure can be associated with a troublesome degree of pain that prevent some
      women from choosing its use. Different interventions have been described to decrease pain
      perception during intrauterine device insertion with no agreement on an effective one.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trial
primary purpose: Prevention
masking: Single (Participant)
masking description: randomized controlled trial
measure: The difference in visual analog scale pain scores during intrauterine device insertion
time frame: 10 minuts
description: The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
measure: the difference in visual analog scale pain scores during tenaculum application
time frame: 10 minuts
description: The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10
measure: the ease of IUD insertion
time frame: 10 minutes
description: the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)
measure: women's satisfaction level: score
time frame: 10 minutes
description: women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction
arm group label: isonicotinic acid hydrazide
arm group type: Experimental
description: 2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.
arm group label: dinoprostone
arm group type: Active Comparator
description: 2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion.
arm group label: misoprostol
arm group type: Active Comparator
description: 2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 12hours before IUD insertion.
intervention type: Drug
intervention name: Isonicotinic Acid Hydrazide
description: 2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.
arm group label: isonicotinic acid hydrazide
other name: INH
intervention type: Drug
intervention name: dinoprostine
description: 2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
arm group label: dinoprostone
other name: prostin
intervention type: Drug
intervention name: misoprostol
description: 2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion
arm group label: misoprostol
other name: Misotac
criteria: 
gender: Female
gender based: Yes
gender description: nulliparous women
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: nahla w Shady, md
role: Study Chair
affiliation: Aswan universirty
last name: hany f Sallam, md
phone: +20102435461
phone ext: 002
email: hany.farouk@aswu.edu.eg
last name: nahla w Shady, md
phone: +201022336052
phone ext: 002
email: hanygyne@yahoo.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: A Professor
mesh term: Isoniazid
mesh term: Misoprostol
sharing ipd: No