<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/NCT03820206</url>
  </required_header>
  <id_info>
    <org_study_id>50</org_study_id>
    <nct_id>NCT03820206</nct_id>
  </id_info>
  <brief_title>The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women</brief_title>
  <official_title>The Value of Tranxemic Acid to Reduce Intraoperative Blood Loss During Elective Cesarean Sections in High Risk Women: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      A full medical history will be obtained from all participants. Obstetric ultrasonography and&#xD;
      laboratory tests will be performed.According to group assignment, either 1 g(10 mL)&#xD;
      tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or&#xD;
      30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision&#xD;
      over a 5-minute period.&#xD;
&#xD;
      Following delivery, patients in both groups will receive an intravenous bolus of 5 IU&#xD;
      oxytocin , 1 mL(0.2 mg) intramuscular ergometrine , and 20 IU oxytocin in 500 mL lactated&#xD;
      Ringer's solution(infused at a rate of 125 mL/h)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A full medical history will be obtained from all participants. Obstetric ultrasonography and&#xD;
      laboratory tests will be performed, including prothrombin time, prothrombin concentration,&#xD;
      complete blood count, and liver and kidney function tests. Maternal body weight and vital&#xD;
      signs (heart rate, blood pressure, and respiratory rate) will be checked 30 minutes before&#xD;
      surgery. According to group assignment, either 1 g(10 mL) tranexamic acid (Kapron, Amoun,&#xD;
      Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of&#xD;
      5% glucose will be slowly administered intravenously 15 minutes before skin incision over a&#xD;
      5-minute period.&#xD;
&#xD;
      Following delivery, patients in both groups will receive an intravenous bolus of 5 IU&#xD;
      oxytocin (Syntocinon, Novartis, Basel, Switzerland), 1 mL(0.2 mg) intramuscular ergometrine&#xD;
      (Methergin, Novartis, Basel, Switzerland), and 20 IU oxytocin in 500 mL lactated Ringer's&#xD;
      solution(infused at a rate of 125 mL/h).&#xD;
&#xD;
      Fluid monitoring will be performed through rate of infusion and urine output. A complete&#xD;
      blood count test will be performed 24 hours after delivery. On discharge, patients who&#xD;
      received tranexamic acid will be given a brief orientation regarding symptoms and signs of a&#xD;
      thromboembolic event and will be instructed to contact the investigators immediately if any&#xD;
      occurred.&#xD;
&#xD;
      All patients will be examined for thromboembolic events at the 1- and 4-week follow-up visits&#xD;
&#xD;
      EBL will be calculated according to the formula:&#xD;
&#xD;
      EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where&#xD;
      EBV is estimated blood volume (mL; weight in kg × 85). For a two-tailed test at an α level of&#xD;
      0.05, the difference between the two groups regarding the primary outcome measure (EBL) had a&#xD;
      power of 1.0 (100%) in a post hoc calculation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">January 2, 2020</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated blood loss (EBL) during cesarean delivery</measure>
    <time_frame>during the operation</time_frame>
    <description>EBL will be calculated according to the formula:&#xD;
EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where EBV is estimated blood volume (mL; weight in kg × 85)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Intraoperative Bleeding</condition>
  <arm_group>
    <arm_group_label>Tranexamic acid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 g (10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.</description>
    <arm_group_label>Tranexamic acid group</arm_group_label>
    <other_name>Kapron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cesarean section</intervention_name>
    <description>Lower segement transverse cesarean section</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Tranexamic acid group</arm_group_label>
    <other_name>Lower segment elective cesarean section</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Grand multipara&#xD;
&#xD;
               -  Multiple pregnancy&#xD;
&#xD;
               -  Polyhydraminos (AFI is more than 24 cm).&#xD;
&#xD;
               -  Placenta previa&#xD;
&#xD;
               -  Gestational diabetes mellitus&#xD;
&#xD;
               -  Preeclampsia&#xD;
&#xD;
               -  Anemia complicating pregnancy (Hemoglobin is less than 11 gm/dl)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Allergy to tranxemic acid.&#xD;
&#xD;
               -  H/o suggestive of bleeding disorders&#xD;
&#xD;
               -  previous history of deep vein thrombosis&#xD;
&#xD;
               -  Abnormally invasive placenta&#xD;
&#xD;
               -  Emergency cesarean sections&#xD;
&#xD;
               -  Intraoprative complications during cesarean sections as uterine artery injury and&#xD;
                  broad ligamentary hematoma.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 2, 2020</last_update_submitted>
  <last_update_submitted_qc>January 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed M Maged, MD</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blood Loss, Surgical</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/NCT03820206
org study id: 50
nct id: NCT03820206
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A full medical history will be obtained from all participants. Obstetric ultrasonography and
      laboratory tests will be performed.According to group assignment, either 1 g(10 mL)
      tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or
      30 mL of 5% glucose will be slowly administered intravenously 15 minutes before skin incision
      over a 5-minute period.

      Following delivery, patients in both groups will receive an intravenous bolus of 5 IU
      oxytocin , 1 mL(0.2 mg) intramuscular ergometrine , and 20 IU oxytocin in 500 mL lactated
      Ringer's solution(infused at a rate of 125 mL/h)
A full medical history will be obtained from all participants. Obstetric ultrasonography and
      laboratory tests will be performed, including prothrombin time, prothrombin concentration,
      complete blood count, and liver and kidney function tests. Maternal body weight and vital
      signs (heart rate, blood pressure, and respiratory rate) will be checked 30 minutes before
      surgery. According to group assignment, either 1 g(10 mL) tranexamic acid (Kapron, Amoun,
      Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose or 30 mL of
      5% glucose will be slowly administered intravenously 15 minutes before skin incision over a
      5-minute period.

      Following delivery, patients in both groups will receive an intravenous bolus of 5 IU
      oxytocin (Syntocinon, Novartis, Basel, Switzerland), 1 mL(0.2 mg) intramuscular ergometrine
      (Methergin, Novartis, Basel, Switzerland), and 20 IU oxytocin in 500 mL lactated Ringer's
      solution(infused at a rate of 125 mL/h).

      Fluid monitoring will be performed through rate of infusion and urine output. A complete
      blood count test will be performed 24 hours after delivery. On discharge, patients who
      received tranexamic acid will be given a brief orientation regarding symptoms and signs of a
      thromboembolic event and will be instructed to contact the investigators immediately if any
      occurred.

      All patients will be examined for thromboembolic events at the 1- and 4-week follow-up visits

      EBL will be calculated according to the formula:

      EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where
      EBV is estimated blood volume (mL; weight in kg × 85). For a two-tailed test at an α level of
      0.05, the difference between the two groups regarding the primary outcome measure (EBL) had a
      power of 1.0 (100%) in a post hoc calculation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Estimated blood loss (EBL) during cesarean delivery
time frame: during the operation
description: EBL will be calculated according to the formula:
EBL = EBV x Preoperative hematocrit-Postoperative hematocrit Preoperative hematocrit where EBV is estimated blood volume (mL; weight in kg × 85)
arm group label: Tranexamic acid group
arm group type: Active Comparator
description: 1 g (10 mL) tranexamic acid (Kapron, Amoun, Egypt; stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.
arm group label: Control group
arm group type: Placebo Comparator
description: 30 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.
intervention type: Drug
intervention name: Tranexamic Acid
description: 1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.
arm group label: Tranexamic acid group
other name: Kapron
intervention type: Procedure
intervention name: Cesarean section
description: Lower segement transverse cesarean section
arm group label: Control group
arm group label: Tranexamic acid group
other name: Lower segment elective cesarean section
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: Professor
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed M Maged, MD
investigator title: Principal investigator
mesh term: Blood Loss, Surgical
mesh term: Tranexamic Acid
sharing ipd: Undecided