<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/NCT04500002</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/354/3/19</org_study_id>
    <nct_id>NCT04500002</nct_id>
  </id_info>
  <brief_title>Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion</brief_title>
  <official_title>Adjuvant Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage: A Randomized Controlled 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>
      The primary endpoint was the success rate of adjuvant isonicotinic acid hydrazide (INH) and&#xD;
      misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the American college of obstetricians and gynecologists (2005), medical abortion&#xD;
      is an acceptable alternative for surgical procedures in pregnant women with gestational age&#xD;
      of less than 10 weeks based on the last menstrual period&#xD;
&#xD;
      Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days&#xD;
      before the 12th week&#xD;
&#xD;
      Adjuvant isonicotinic acid hydrazide (INH) administration with misoprostol raises the rate of&#xD;
      complete abortion&#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">July 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 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>double blind randomized parallel assign controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind randomized parallel assign controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>number of patients with complete abortion</measure>
    <time_frame>12 hours</time_frame>
    <description>number of patients with complete abortion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time from induction to abortion</measure>
    <time_frame>12 hours</time_frame>
    <description>time from induction to abortion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of the women will undergo dilatation and curettage after failed medical induction of abortion</measure>
    <time_frame>12 hours</time_frame>
    <description>number of the women will undergo dilatation and curettage after failed medical induction of abortion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>IUCD Complication</condition>
  <arm_group>
    <arm_group_label>INH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily doses, 5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum three doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Misoprostol Alone 800 mcg every three hours up to maximum three doses</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isonicotinic Acid Hydrazide</intervention_name>
    <description>total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion</description>
    <arm_group_label>INH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Misoprosrol 800mcg will be given to all patients for induction of abortion</description>
    <arm_group_label>INH</arm_group_label>
    <arm_group_label>Misoprostol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age less than 70 days gestation (&lt;10 wks)&#xD;
&#xD;
          -  Hemoglobin &gt;10 g/dL.&#xD;
&#xD;
          -  BMI between 18.5 kg/m2 and 30 kg/m2.&#xD;
&#xD;
          -  Missed abortion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Molar pregnancy.&#xD;
&#xD;
          -  Fibroid uterus.&#xD;
&#xD;
          -  Uterine anomalies.&#xD;
&#xD;
          -  Coagulopathy.&#xD;
&#xD;
          -  Medical disorder that contraindicate induction of abortion (e.g. heart failure).&#xD;
&#xD;
          -  Previous attempts for induction of abortion in the current pregnancy.&#xD;
&#xD;
          -  Allergy to misoprostol or letrozole.&#xD;
&#xD;
          -  Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured&#xD;
             uterus).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women with gestational age of less than 10 week</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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 waer Shady</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 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 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/NCT04500002
org study id: aswu/354/3/19
nct id: NCT04500002
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary endpoint was the success rate of adjuvant isonicotinic acid hydrazide (INH) and
      misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.
According to the American college of obstetricians and gynecologists (2005), medical abortion
      is an acceptable alternative for surgical procedures in pregnant women with gestational age
      of less than 10 weeks based on the last menstrual period

      Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days
      before the 12th week

      Adjuvant isonicotinic acid hydrazide (INH) administration with misoprostol raises the rate of
      complete abortion
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind randomized parallel assign controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind randomized parallel assign controlled trial
measure: number of patients with complete abortion
time frame: 12 hours
description: number of patients with complete abortion
measure: time from induction to abortion
time frame: 12 hours
description: time from induction to abortion
measure: number of the women will undergo dilatation and curettage after failed medical induction of abortion
time frame: 12 hours
description: number of the women will undergo dilatation and curettage after failed medical induction of abortion
arm group label: INH
arm group type: Experimental
description: 3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily doses, 5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum three doses.
arm group label: Misoprostol
arm group type: Active Comparator
description: Misoprostol Alone 800 mcg every three hours up to maximum three doses
intervention type: Drug
intervention name: Isonicotinic Acid Hydrazide
description: total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
arm group label: INH
intervention type: Drug
intervention name: Misoprostol
description: Misoprosrol 800mcg will be given to all patients for induction of abortion
arm group label: INH
arm group label: Misoprostol
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women with gestational age of less than 10 week
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: hany f Sallam, md
phone: +20102435461
phone ext: 002
email: hany.farouk@aswu.edu.eg
last name: nahla waer Shady
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