<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/NCT04482881</url>
  </required_header>
  <id_info>
    <org_study_id>labour induction</org_study_id>
    <nct_id>NCT04482881</nct_id>
  </id_info>
  <brief_title>Isosorbide Mononitrate in Induction of Labour</brief_title>
  <official_title>Isosorbide Mononitrate and Misoprostol in Induction of Labour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Suez Canal University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aljazeera 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Induction of labor is defined as the process of artificially initiating uterine contractions,&#xD;
      prior to their spontaneous onset, with progressive effacement and dilatation of the cervix&#xD;
      and ultimately, the delivery of the baby.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are many indications for induction of labor in the obstetric practice, of which&#xD;
      prolonged gestational age stands as the most common cause.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 21, 2020</start_date>
  <completion_date type="Anticipated">September 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 20, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the number of women who will be reach active phase within 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>how many women will reach active phase within 24 hours</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Labor Fast</condition>
  <arm_group>
    <arm_group_label>women receiving isosorbide mononitrates lower dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>women who will receive isosorbide mononitrates lower dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>women receiving isosorbide mononitrates higher dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>women who will receive isosorbide mononitrates higher dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women receiving misoprostol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women who will receive misoprostol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isosorbide Mononitrate 40 MG</intervention_name>
    <description>giving women isosorbide mononitrate 40 MG</description>
    <arm_group_label>women receiving isosorbide mononitrates lower dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isosorbide Mononitrate 60 MG</intervention_name>
    <description>giving women isosorbide mononitrate 60MG</description>
    <arm_group_label>women receiving isosorbide mononitrates higher dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Giving women misoprostol</description>
    <arm_group_label>Women receiving misoprostol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single vertex presentation. 2. Gestational age &gt; 37weeks calculated from last&#xD;
             menstrual period or U/S scanning.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with rupture of membranes.&#xD;
&#xD;
          2. Previous uterine scar.&#xD;
&#xD;
          3. Fetal malpresentation.&#xD;
&#xD;
          4. Multiple pregnancies.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Alalfy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Algezeera hospitaland National Research Centre ,Egypt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahmoud Alalfy</last_name>
    <phone>01002611058</phone>
    <email>mahmoudalalfy@ymail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Algazeerah</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mahmoud Alalfy, master</last_name>
      <phone>+201002611058</phone>
      <email>mahmoudalalfy@ymail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ahmed Elgazzar, M.D</last_name>
      <phone>+201014005959</phone>
    </contact_backup>
    <investigator>
      <last_name>Mahmoud Alalfy, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isosorbide</mesh_term>
    <mesh_term>Isosorbide Dinitrate</mesh_term>
    <mesh_term>Isosorbide-5-mononitrate</mesh_term>
    <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/NCT04482881
org study id: labour induction
nct id: NCT04482881
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Induction of labor is defined as the process of artificially initiating uterine contractions,
      prior to their spontaneous onset, with progressive effacement and dilatation of the cervix
      and ultimately, the delivery of the baby.
There are many indications for induction of labor in the obstetric practice, of which
      prolonged gestational age stands as the most common cause.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: the number of women who will be reach active phase within 24 hours
time frame: 24 hours
description: how many women will reach active phase within 24 hours
arm group label: women receiving isosorbide mononitrates lower dose
arm group type: Active Comparator
description: women who will receive isosorbide mononitrates lower dose
arm group label: women receiving isosorbide mononitrates higher dose
arm group type: Active Comparator
description: women who will receive isosorbide mononitrates higher dose
arm group label: Women receiving misoprostol
arm group type: Active Comparator
description: Women who will receive misoprostol
intervention type: Drug
intervention name: Isosorbide Mononitrate 40 MG
description: giving women isosorbide mononitrate 40 MG
arm group label: women receiving isosorbide mononitrates lower dose
intervention type: Drug
intervention name: Isosorbide Mononitrate 60 MG
description: giving women isosorbide mononitrate 60MG
arm group label: women receiving isosorbide mononitrates higher dose
intervention type: Drug
intervention name: Misoprostol
description: Giving women misoprostol
arm group label: Women receiving misoprostol
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Alalfy, PhD
role: Principal Investigator
affiliation: Algezeera hospitaland National Research Centre ,Egypt
last name: Mahmoud Alalfy
phone: 01002611058
email: mahmoudalalfy@ymail.com
facility: 
contact: 
contact backup: 
investigator: 
country: Egypt
responsible party type: Sponsor
mesh term: Isosorbide
mesh term: Isosorbide Dinitrate
mesh term: Isosorbide-5-mononitrate
mesh term: Misoprostol