<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/NCT04499989</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/353/4/19</org_study_id>
    <nct_id>NCT04499989</nct_id>
  </id_info>
  <brief_title>Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion</brief_title>
  <official_title>Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery: a Randomized Double Blinded Clinical Trial</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 investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine&#xD;
      device (IUD) insertion reduces failed insertions, insertion-related complications and pain in&#xD;
      in Women Delivered Only by Cesarean Delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women may experience pain and technical difficulties may be encountered when insertion of an&#xD;
      intrauterine device is attempted through a narrow cervical canal. intrauterine device&#xD;
      insertion- related complications and side effects are more common among women who had never&#xD;
      delivered vaginally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>double blind randomized trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind randomized trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the difference in the pain intensity scores between the study groups</measure>
    <time_frame>10 minutes</time_frame>
    <description>the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provider ease of insertion</measure>
    <time_frame>10 minutes</time_frame>
    <description>Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>insertion time</measure>
    <time_frame>10 minutes</time_frame>
    <description>IUD insertion time from speculum in to speculum out</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>IUCD Complication</condition>
  <arm_group>
    <arm_group_label>INH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INH</intervention_name>
    <description>3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.</description>
    <arm_group_label>INH</arm_group_label>
    <other_name>isonicotinic acid hydrazide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Comparator</intervention_name>
    <description>3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion</description>
    <arm_group_label>Placebo Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-pregnant women&#xD;
&#xD;
          -  Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to&#xD;
             insertion&#xD;
&#xD;
          -  Women who delivered only by cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with any uterine abnormalities as congenital anomalies, endometrial lesions,&#xD;
             adenomyosis, fibroids.&#xD;
&#xD;
          -  Those with a Category 3 or 4 conditions for intrauterine device insertion according to&#xD;
             the WHO Medical Eligibility Criteria for contraceptive use&#xD;
&#xD;
          -  Allergy to isonicotinic acid hydrazide .&#xD;
&#xD;
          -  Women refuse to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women Delivered Only by Elective Cesarean Section</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>
  <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 2021</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</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>
  </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/NCT04499989
org study id: aswu/353/4/19
nct id: NCT04499989
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine
      device (IUD) insertion reduces failed insertions, insertion-related complications and pain in
      in Women Delivered Only by Cesarean Delivery.
Women may experience pain and technical difficulties may be encountered when insertion of an
      intrauterine device is attempted through a narrow cervical canal. intrauterine device
      insertion- related complications and side effects are more common among women who had never
      delivered vaginally.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind randomized trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind randomized trial
measure: the difference in the pain intensity scores between the study groups
time frame: 10 minutes
description: the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain
measure: Provider ease of insertion
time frame: 10 minutes
description: Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.
measure: insertion time
time frame: 10 minutes
description: IUD insertion time from speculum in to speculum out
arm group label: INH
arm group type: Experimental
description: 3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
arm group label: Placebo Comparator
arm group type: Placebo Comparator
description: 3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.
intervention type: Drug
intervention name: INH
description: 3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.
arm group label: INH
other name: isonicotinic acid hydrazide
intervention type: Drug
intervention name: Placebo Comparator
description: 3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion
arm group label: Placebo Comparator
criteria: 
gender: Female
gender based: Yes
gender description: Women Delivered Only by Elective Cesarean Section
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: nahla w Shady, md
role: Study Chair
affiliation: Aswan universirty
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
sharing ipd: No