<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/NCT03829592</url>
  </required_header>
  <id_info>
    <org_study_id>Misoprostol</org_study_id>
    <nct_id>NCT03829592</nct_id>
  </id_info>
  <brief_title>TheEffect of pH on Misoprostol in Induction of Labor</brief_title>
  <official_title>TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kasr El Aini Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was&#xD;
      initially marketed for the treatment of peptic ulcers due to its mucosal protective and&#xD;
      anti-secretory properties, but has commonly been used for the induction of abortion and&#xD;
      labour .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although initially having been established for oral use, misoprostol tablets are commonly&#xD;
      used as vaginal suppositories for the previously purposes. Water or saline are frequently&#xD;
      used in common practice to moisten the tablets prior to their administration, however,&#xD;
      according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">July 12, 2020</completion_date>
  <primary_completion_date type="Actual">May 10, 2020</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>3 paralle groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of women who will start lactive phase of labour after treatment</measure>
    <time_frame>within 24 hours</time_frame>
    <description>the number of women in a group who will enter in active labour faster than other groups</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>misoprostol in neutral media</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention : misoprostol in a neutral media will be given to women to induce labour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol in acidic media</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention : misoprostol in acidic media will be given to induce labour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol in alkaline media</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Intervention : misoprostol in alkaline media will be given to induce labour</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>misoprostol in a neutral media</intervention_name>
    <description>giving misoprostol in a neutral media</description>
    <arm_group_label>misoprostol in neutral media</arm_group_label>
    <other_name>Drug (misoprostol + neutral media )</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>misoprostol in an acidic media</intervention_name>
    <description>giving misoprostol in an acidic media</description>
    <arm_group_label>Misoprostol in acidic media</arm_group_label>
    <other_name>Drug ( Misoprostol + acidic media )</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>misoprostol in an alkaline media</intervention_name>
    <description>giving misoprostol in an alkaline media</description>
    <arm_group_label>Misoprostol in alkaline media</arm_group_label>
    <other_name>Drug ( misoprostol + alkaline media )</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Full term pregnant women</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Alalfy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algazeerah and Kasralainy hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <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>May 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 16, 2020</last_update_submitted>
  <last_update_submitted_qc>May 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03829592
org study id: Misoprostol
nct id: NCT03829592
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was
      initially marketed for the treatment of peptic ulcers due to its mucosal protective and
      anti-secretory properties, but has commonly been used for the induction of abortion and
      labour .
Although initially having been established for oral use, misoprostol tablets are commonly
      used as vaginal suppositories for the previously purposes. Water or saline are frequently
      used in common practice to moisten the tablets prior to their administration, however,
      according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 paralle groups
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The number of women who will start lactive phase of labour after treatment
time frame: within 24 hours
description: the number of women in a group who will enter in active labour faster than other groups
arm group label: misoprostol in neutral media
arm group type: Placebo Comparator
description: Intervention : misoprostol in a neutral media will be given to women to induce labour
arm group label: Misoprostol in acidic media
arm group type: Active Comparator
description: Intervention : misoprostol in acidic media will be given to induce labour
arm group label: Misoprostol in alkaline media
arm group type: Sham Comparator
description: Intervention : misoprostol in alkaline media will be given to induce labour
intervention type: Drug
intervention name: misoprostol in a neutral media
description: giving misoprostol in a neutral media
arm group label: misoprostol in neutral media
other name: Drug (misoprostol + neutral media )
intervention type: Drug
intervention name: misoprostol in an acidic media
description: giving misoprostol in an acidic media
arm group label: Misoprostol in acidic media
other name: Drug ( Misoprostol + acidic media )
intervention type: Drug
intervention name: misoprostol in an alkaline media
description: giving misoprostol in an alkaline media
arm group label: Misoprostol in alkaline media
other name: Drug ( misoprostol + alkaline media )
criteria: 
gender: Female
gender based: Yes
gender description: Full term pregnant women
minimum age: 20 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Alalfy
role: Principal Investigator
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
responsible party type: Sponsor
mesh term: Labor Pain
mesh term: Misoprostol