<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/NCT03778242</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/276/18</org_study_id>
    <nct_id>NCT03778242</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.</brief_title>
  <official_title>The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for Reducing Blood Loss During Hemorrhagic Cesarean Delivery: 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>
    <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 evaluate the effects of topical tranexamic acid (TA) on reducing post-partum&#xD;
      hemorrhage in pregnant women with hemorrhagic cesarean section&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of&#xD;
      PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting&#xD;
      in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine&#xD;
      contraction following delivery is an important issue. The aim of the study is to To explore&#xD;
      the efficacy and safety of temporary uterine packing combined with topical tranexamic acid&#xD;
      (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD),&#xD;
      compared with placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</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>open label Randomized Clinical Tria</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open label Randomized Clinical Tria</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>number of patients need of additional pharmacological uterotonic</measure>
    <time_frame>24 hours post operative</time_frame>
    <description>calculation number of patients need of additional pharmacological uterotonic</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>estimation of intraoperative blood loss (ml)</measure>
    <time_frame>during the operation</time_frame>
    <description>measure Intraoperative blood loss in ml by gravimetric methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of postoperative blood loss</measure>
    <time_frame>4 hours postoperative</time_frame>
    <description>measure amount of blood loss post operative in ml by gravimetric methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patient with postpartum hemorrhage</measure>
    <time_frame>24 hours post operative</time_frame>
    <description>calculation of the number of the patients with blood loss &gt;1000 ml</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>Topical tranexamic acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical tranexamic acid</intervention_name>
    <description>temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid</description>
    <arm_group_label>Topical tranexamic acid</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <description>2 placebo ampoules to TA in 100 ml saline by slow infusion</description>
    <arm_group_label>normal saline</arm_group_label>
    <other_name>Placebo comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who were admitted for an elective or non-emergency CS during labor and&#xD;
             exposed to intraoperative bleeding about 800 ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  placenta praevia and placental abruption&#xD;
&#xD;
          -  Women with a medical disorder,&#xD;
&#xD;
          -  placenta accrete,&#xD;
&#xD;
          -  allergy to TA, and&#xD;
&#xD;
          -  intraoperative bleeding thanks to causes aside from uterine atony&#xD;
&#xD;
          -  Patients over 40 or who have&#xD;
&#xD;
               -  pre-existing coagulation disorders,&#xD;
&#xD;
          -  with a severe medical disorder&#xD;
&#xD;
          -  allergy to tranexamic acid&#xD;
&#xD;
          -  refuse to consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 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>
  <location>
    <facility>
      <name>Aswan University</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</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>postpartum hemorrhage</keyword>
  <keyword>oxytocin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03778242
org study id: aswu/276/18
nct id: NCT03778242
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum
      hemorrhage in pregnant women with hemorrhagic cesarean section
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of
      PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting
      in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine
      contraction following delivery is an important issue. The aim of the study is to To explore
      the efficacy and safety of temporary uterine packing combined with topical tranexamic acid
      (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD),
      compared with placebo.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: open label Randomized Clinical Tria
primary purpose: Prevention
masking: None (Open Label)
masking description: open label Randomized Clinical Tria
measure: number of patients need of additional pharmacological uterotonic
time frame: 24 hours post operative
description: calculation number of patients need of additional pharmacological uterotonic
measure: estimation of intraoperative blood loss (ml)
time frame: during the operation
description: measure Intraoperative blood loss in ml by gravimetric methods
measure: amount of postoperative blood loss
time frame: 4 hours postoperative
description: measure amount of blood loss post operative in ml by gravimetric methods
measure: number of patient with postpartum hemorrhage
time frame: 24 hours post operative
description: calculation of the number of the patients with blood loss >1000 ml
arm group label: Topical tranexamic acid
arm group type: Active Comparator
description: temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
arm group label: normal saline
arm group type: Placebo Comparator
description: temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
intervention type: Drug
intervention name: Topical tranexamic acid
description: temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
arm group label: Topical tranexamic acid
other name: Active Comparator
intervention type: Drug
intervention name: normal saline
description: 2 placebo ampoules to TA in 100 ml saline by slow infusion
arm group label: normal saline
other name: Placebo comparator
criteria: 
gender: Female
gender based: Yes
gender description: patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: hany f sallam, md
role: Principal Investigator
affiliation: Aswan University Hospital
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: Principal Investigator
mesh term: Tranexamic Acid
sharing ipd: Undecided