<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/NCT04427618</url>
  </required_header>
  <id_info>
    <org_study_id>2019/2425</org_study_id>
    <nct_id>NCT04427618</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section</brief_title>
  <official_title>Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KK Women's and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KK Women's and Children's 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal&#xD;
      morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the&#xD;
      prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH&#xD;
      prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process&#xD;
      further by inhibiting the fibrinolytic system.&#xD;
&#xD;
      TXA is an antifibrinolytic that has been studied in many different patient population for its&#xD;
      use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to&#xD;
      trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and&#xD;
      recent evidence have found promising results in its use for prophylaxis of PPH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 3, 2021</primary_completion_date>
  <phase>Phase 3</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</measure>
    <time_frame>Intraoperative</time_frame>
    <description>This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hemoglobin and hematocrit level</measure>
    <time_frame>Preoperative to 48 hours postoperative</time_frame>
    <description>Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for additional medical intervention including blood transfusion, additional uterotonics</measure>
    <time_frame>During surgery and up to 3 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postpartum hemorrhage: defined as &gt;1000ml total blood loss within 24 hours after delivery</measure>
    <time_frame>During surgery and up to 24 hours from surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism</measure>
    <time_frame>Intraoperative to 4 weeks post surgery</time_frame>
    <description>Patients will be reviewed for signs and symptoms of thromboembolic events. They will be reviewed daily post surgery in the ward as per routine protocol. Generally, all post caesarean section patients will be warded till post operative day 3. They will also have a routine follow up 4 weeks post surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal APGAR score</measure>
    <time_frame>At delivery</time_frame>
    <description>Neonatal APGAR score at 1 and 5 minutes of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal birth weight</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal admission to special care nursery or intensive care unit</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnosis of thromboembolic events in the neonate</measure>
    <time_frame>Up to 4 weeks post delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gravimetric estimation of blood loss during the surgery</measure>
    <time_frame>Intraoperative</time_frame>
    <description>This would be assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider estimated blood loss</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Estimated by the surgical team</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <condition>Tranexamic Acid</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision, and Intravenous oxytocin 5 units post delivery of the baby.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid</intervention_name>
    <description>Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All English speaking patients&#xD;
&#xD;
          -  Above 21 year old&#xD;
&#xD;
          -  Undergoing elective caesarean section.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known/suspected placenta accreta antenatally&#xD;
&#xD;
          -  Contraindications to syntocinon and tranexamic acid such as hypersensitivity to these&#xD;
             medications&#xD;
&#xD;
          -  Known thrombophilia or coagulopathy&#xD;
&#xD;
          -  History of thromboembolic events&#xD;
&#xD;
          -  Severe cardiac/renal/liver disease&#xD;
&#xD;
          -  Poorly controlled hypertension /severe preeclampsia (BP &gt; 160/100)/eclampsia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manisha Mathur</last_name>
    <role>Principal Investigator</role>
    <affiliation>KK Women's and Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KK Women's and Children's Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>November 6, 2022</last_update_submitted>
  <last_update_submitted_qc>November 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</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>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/NCT04427618
org study id: 2019/2425
nct id: NCT04427618
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal
      morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the
      prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH
      prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process
      further by inhibiting the fibrinolytic system.

      TXA is an antifibrinolytic that has been studied in many different patient population for its
      use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to
      trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and
      recent evidence have found promising results in its use for prophylaxis of PPH.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Estimated blood loss
time frame: Intraoperative
description: This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85.
measure: Change in hemoglobin and hematocrit level
time frame: Preoperative to 48 hours postoperative
description: Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery
measure: Need for additional medical intervention including blood transfusion, additional uterotonics
time frame: During surgery and up to 3 days after surgery
measure: Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery
time frame: During surgery and up to 24 hours from surgery
measure: Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism
time frame: Intraoperative to 4 weeks post surgery
description: Patients will be reviewed for signs and symptoms of thromboembolic events. They will be reviewed daily post surgery in the ward as per routine protocol. Generally, all post caesarean section patients will be warded till post operative day 3. They will also have a routine follow up 4 weeks post surgery.
measure: Neonatal APGAR score
time frame: At delivery
description: Neonatal APGAR score at 1 and 5 minutes of life
measure: Neonatal birth weight
time frame: At delivery
measure: Neonatal admission to special care nursery or intensive care unit
time frame: At delivery
measure: Diagnosis of thromboembolic events in the neonate
time frame: Up to 4 weeks post delivery
measure: Gravimetric estimation of blood loss during the surgery
time frame: Intraoperative
description: This would be assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted
measure: Provider estimated blood loss
time frame: Intraoperative
description: Estimated by the surgical team
arm group label: Intervention group
arm group type: Experimental
description: Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision, and Intravenous oxytocin 5 units post delivery of the baby.
arm group label: Control group
arm group type: Placebo Comparator
description: Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby
intervention type: Drug
intervention name: Tranexamic acid
description: Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
arm group label: Intervention group
intervention type: Drug
intervention name: Normal saline
description: Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision
arm group label: Control group
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manisha Mathur
role: Principal Investigator
affiliation: KK Women's and Children's Hospital
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Tranexamic Acid
sharing ipd: Undecided