<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/NCT04499976</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/353/3/19</org_study_id>
    <nct_id>NCT04499976</nct_id>
  </id_info>
  <brief_title>Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage</brief_title>
  <official_title>Adjuvant Isonicotinic Acid Hydrazide (INH) With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: 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>
      This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol&#xD;
      versus misoprostol alone for medical termination of first-trimester pregnancy among women&#xD;
      with one or more previous cesarean deliveries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing&#xD;
      intraoperative complications of cervical dilatation have been proven . Misoprostol is a&#xD;
      synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now&#xD;
      widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology&#xD;
      include medical abortion in the first and second trimesters of pregnancy.&#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">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 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 controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind randomized controlled study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>induction to abortion time</measure>
    <time_frame>9 hours</time_frame>
    <description>induction to abortion time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of patient with complete abortion</measure>
    <time_frame>9 hours</time_frame>
    <description>number of patient with complete abortion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of patient need for surgical evacuation of the products of conception</measure>
    <time_frame>12 hours</time_frame>
    <description>number of patient need for surgical evacuation of the products of conception</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Abortion, Missed</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 dose, 900 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 two doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isonicotinic Acid</intervention_name>
    <description>Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days</description>
    <arm_group_label>INH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Drug: placebo then misoprostol Drug: Placebo placebo for 3 days</description>
    <arm_group_label>Placebo Comparator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion</description>
    <arm_group_label>INH</arm_group_label>
    <arm_group_label>Placebo Comparator</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;
          -  previous one or more cesarean deliveries&#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 INH.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women with one or more previous cesarean deliveries with missed miscarriage</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</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 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Abortion, Missed</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04499976
org study id: aswu/353/3/19
nct id: NCT04499976
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol
      versus misoprostol alone for medical termination of first-trimester pregnancy among women
      with one or more previous cesarean deliveries.
In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing
      intraoperative complications of cervical dilatation have been proven . Misoprostol is a
      synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now
      widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology
      include medical abortion in the first and second trimesters of pregnancy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind randomized controlled study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind randomized controlled study
measure: induction to abortion time
time frame: 9 hours
description: induction to abortion time
measure: number of patient with complete abortion
time frame: 9 hours
description: number of patient with complete abortion
measure: number of patient need for surgical evacuation of the products of conception
time frame: 12 hours
description: number of patient need for surgical evacuation of the products of conception
arm group label: INH
arm group type: Experimental
description: 3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily dose, 900 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 two doses.
arm group label: Placebo Comparator
arm group type: Placebo Comparator
description: three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
intervention type: Drug
intervention name: Isonicotinic Acid
description: Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days
arm group label: INH
intervention type: Drug
intervention name: Placebo
description: Drug: placebo then misoprostol Drug: Placebo placebo for 3 days
arm group label: Placebo Comparator
intervention type: Drug
intervention name: Misoprostol
description: Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
arm group label: INH
arm group label: Placebo Comparator
criteria: 
gender: Female
gender based: Yes
gender description: women with one or more previous cesarean deliveries with missed miscarriage
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: nahla w Shady
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: Abortion, Spontaneous
mesh term: Abortion, Missed
mesh term: Misoprostol
sharing ipd: No