<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/NCT04463966</url>
  </required_header>
  <id_info>
    <org_study_id>Tranexamic</org_study_id>
    <nct_id>NCT04463966</nct_id>
  </id_info>
  <brief_title>Prevention of Postpartum Haemorrhage</brief_title>
  <official_title>Tranexamic Acid for the Prevention of Postpartum Haemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha University</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>
      Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients:&#xD;
      Randomized Control Trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to assess the efficacy of administration of Tranexamic Acid in preventing&#xD;
      Postpartum haemorrhage &amp; reducing intraoperative and postoperative blood loss in high risk&#xD;
      women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to&#xD;
      transfusion-sparing and hysterectomy-sparing. &amp; reduction of hemorrhage-related mortality&#xD;
      when Postpartum hemorrhage is expected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">April 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>blood loss</measure>
    <time_frame>immediately after deliver</time_frame>
    <description>Estimation of blood loss</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>immediately after delivery</time_frame>
    <description>blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulse</measure>
    <time_frame>immediately after delivery</time_frame>
    <description>pulse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>temperature</measure>
    <time_frame>immeditely after delivery</time_frame>
    <description>temperature</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Post Partum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Study</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group will not be given tranexamic acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid injection</intervention_name>
    <description>1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .</description>
    <arm_group_label>Study</arm_group_label>
    <other_name>Kapron, 500 mg/5ml</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women at high risk for postpartum hemorrhage after cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women who are not at high risk for postpartum hemorrhage , or attending for normal&#xD;
             vaginal delivery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaimaa Ezzat</last_name>
    <role>Principal Investigator</role>
    <affiliation>Police Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aboubakr Elnashar, MD</last_name>
    <phone>00201066934749</phone>
    <email>elnashar53@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>shaimaa ezzat</last_name>
    <phone>00201009023289</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Police Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaimaa ezzat</last_name>
      <phone>00201009023289</phone>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Dr. Abou Bakr Mohamed El Nashaar</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>tranexamic acid</keyword>
  <keyword>postpartum hemorrhage</keyword>
  <keyword>cesarean section</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <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/NCT04463966
org study id: Tranexamic
nct id: NCT04463966
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients:
      Randomized Control Trial
This study aims to assess the efficacy of administration of Tranexamic Acid in preventing
      Postpartum haemorrhage & reducing intraoperative and postoperative blood loss in high risk
      women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to
      transfusion-sparing and hysterectomy-sparing. & reduction of hemorrhage-related mortality
      when Postpartum hemorrhage is expected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: blood loss
time frame: immediately after deliver
description: Estimation of blood loss
measure: blood pressure
time frame: immediately after delivery
description: blood pressure
measure: pulse
time frame: immediately after delivery
description: pulse
measure: temperature
time frame: immeditely after delivery
description: temperature
arm group label: Study
arm group type: Active Comparator
description: Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
arm group label: Control
arm group type: No Intervention
description: control group will not be given tranexamic acid
intervention type: Drug
intervention name: Tranexamic acid injection
description: 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
arm group label: Study
other name: Kapron, 500 mg/5ml
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shaimaa Ezzat
role: Principal Investigator
affiliation: Police Hospital
last name: Aboubakr Elnashar, MD
phone: 00201066934749
email: elnashar53@hotmail.com
last name: shaimaa ezzat
phone: 00201009023289
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Dr. Abou Bakr Mohamed El Nashaar
investigator title: professor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Tranexamic Acid
sharing ipd: Undecided