<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/NCT03774706</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/184/18</org_study_id>
    <nct_id>NCT03774706</nct_id>
  </id_info>
  <brief_title>Sublingual Misoprostol With or Without Intravenous Tranexamic Acid During Hemorrhagic Cesarean Section</brief_title>
  <official_title>Role of Sublingual Misoprostol With or Without Intravenous Tranexamic Acid for Reducing Post-partum Hemorrhage During and After Hemorrhagic Cesarean Section: A Double-Blind Randomized 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>No</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>
      Purpose to evaluates the effects of sublingual misoprostol with or without intravenous&#xD;
      tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean&#xD;
      section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Different uterotonic agents administration, mainly oxytocin, has been routinely used to&#xD;
      reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies&#xD;
      reported that oxytocin use in the setting of CS may result in maternal adverse effects,&#xD;
      including hypotension and tachycardia., Therefore, investigating other therapeutic agents&#xD;
      with lower adverse effects and higher efficacy is needed. Recently, a number of studies&#xD;
      reported a correlation between fibrinogen decrease and cesarean-related hemorrhage.&#xD;
      Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic&#xD;
      equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as&#xD;
      tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other&#xD;
      hand, it has been suggested that TA administration reduces blood loss and the incidence of&#xD;
      postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher&#xD;
      efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been&#xD;
      introduced as a uterotonic agent for preventing PPH following CS. A recent study reported&#xD;
      that oral or sublingual misoprostol is more effective than the placebo in reducing severe&#xD;
      PPH, following CS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 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 placebo randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>number of patients develop postpartum hemorrhage</measure>
    <time_frame>6 hours post operative</time_frame>
    <description>calculation of number of patients develop postpartum hemorrhage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraoperative blood loss (ml)</measure>
    <time_frame>during the operation</time_frame>
    <description>calculation of the amount of blood loss in ml by gravimetric methods</description>
  </secondary_outcome>
  <other_outcome>
    <measure>postoperative blood loss (ml)</measure>
    <time_frame>6 hours post operative</time_frame>
    <description>calculation of the amount of blood loss in ml by gravimetric methods</description>
  </other_outcome>
  <other_outcome>
    <measure>number of patients need blood transfusion</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>calculation of number of patients need blood transfusion</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>Misoprostol with TA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Misoprostol with placebo to TA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>two tablets misoprostol 400 μg sublingual</description>
    <arm_group_label>Misoprostol with TA</arm_group_label>
    <arm_group_label>Misoprostol with placebo to TA</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline</description>
    <arm_group_label>Misoprostol with TA</arm_group_label>
    <other_name>active comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to tranexamic acid</intervention_name>
    <description>placebo to tranexamic acid (110 ml saline)</description>
    <arm_group_label>Misoprostol with placebo to TA</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who undergone elective cesarean section (C.S) and exposed to intraoperative&#xD;
             bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus&#xD;
&#xD;
          -  age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS&#xD;
             with inferior segment incision, and spinal anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having an underlying disease (heart, liver, kidney, pulmonary, etc.),&#xD;
&#xD;
          -  eclampsia and severe preeclampsia&#xD;
&#xD;
          -  allergy to TA (such as known allergy or thromboembolic event during pregnancy) and&#xD;
             misoprostol&#xD;
&#xD;
          -  coagulation disorders&#xD;
&#xD;
          -  refuse or unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women who undergo elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hany f sallam, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aswan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>hany f sallam</last_name>
    <phone>01022336052</phone>
    <phone_ext>002</phone_ext>
    <email>hany.farouk@aswu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aswan University</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>hany f sallam, md</last_name>
      <phone>01092440504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.ed.eg</email>
    </contact>
    <contact_backup>
      <last_name>Nahla w Shady, md</last_name>
      <phone>1019240504</phone>
      <phone_ext>002</phone_ext>
      <email>nahla.elsayed@aswu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cesarean section</keyword>
  <keyword>tranexamic acid</keyword>
  <keyword>misoprostol</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Tranexamic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03774706
org study id: aswu/184/18
nct id: NCT03774706
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose to evaluates the effects of sublingual misoprostol with or without intravenous
      tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean
      section.
Different uterotonic agents administration, mainly oxytocin, has been routinely used to
      reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies
      reported that oxytocin use in the setting of CS may result in maternal adverse effects,
      including hypotension and tachycardia., Therefore, investigating other therapeutic agents
      with lower adverse effects and higher efficacy is needed. Recently, a number of studies
      reported a correlation between fibrinogen decrease and cesarean-related hemorrhage.
      Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic
      equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as
      tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other
      hand, it has been suggested that TA administration reduces blood loss and the incidence of
      postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher
      efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been
      introduced as a uterotonic agent for preventing PPH following CS. A recent study reported
      that oral or sublingual misoprostol is more effective than the placebo in reducing severe
      PPH, following CS
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double-blind placebo randomized controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used
measure: number of patients develop postpartum hemorrhage
time frame: 6 hours post operative
description: calculation of number of patients develop postpartum hemorrhage
measure: intraoperative blood loss (ml)
time frame: during the operation
description: calculation of the amount of blood loss in ml by gravimetric methods
measure: postoperative blood loss (ml)
time frame: 6 hours post operative
description: calculation of the amount of blood loss in ml by gravimetric methods
measure: number of patients need blood transfusion
time frame: 24 hours postoperative
description: calculation of number of patients need blood transfusion
arm group label: Misoprostol with TA
arm group type: Active Comparator
description: two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv
arm group label: Misoprostol with placebo to TA
arm group type: Active Comparator
description: two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv
intervention type: Drug
intervention name: Misoprostol
description: two tablets misoprostol 400 μg sublingual
arm group label: Misoprostol with TA
arm group label: Misoprostol with placebo to TA
other name: Active Comparator
intervention type: Drug
intervention name: Tranexamic Acid
description: two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline
arm group label: Misoprostol with TA
other name: active comparator
intervention type: Drug
intervention name: placebo to tranexamic acid
description: placebo to tranexamic acid (110 ml saline)
arm group label: Misoprostol with placebo to TA
other name: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: women who undergo elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: hany f sallam, md
role: Principal Investigator
affiliation: Aswan University Hospital
last name: hany f sallam
phone: 01022336052
phone ext: 002
email: hany.farouk@aswu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: Principal Investigator
mesh term: Misoprostol
mesh term: Tranexamic Acid
sharing ipd: Undecided