<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/NCT03777878</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/186/18</org_study_id>
    <nct_id>NCT03777878</nct_id>
  </id_info>
  <brief_title>Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section</brief_title>
  <official_title>Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid for Prevention of Postpartum Hemorrhage at 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>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>
      Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic&#xD;
      acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean&#xD;
      section with one or more risk factor for postpartum hemorrhage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor&#xD;
      to maternal mortality and morbidity especially in developing countries. The risk of PPH is&#xD;
      much higher for women undergoing cesarean delivery (CD). Oxytocin is regarded as the gold&#xD;
      standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean&#xD;
      section oxytocin must be administered as a continuous intravenous infusion to attain&#xD;
      sustained uterotonic activity throughout the surgical procedure and immediate postpartum&#xD;
      period. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as&#xD;
      a single-dose injection; intravenously administered carbetocin has a half-life of&#xD;
      approximately 40 min.&#xD;
&#xD;
      A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min&#xD;
      and persists for an average of 60 min following injection.&#xD;
&#xD;
      The aim of this study is to compare the effectiveness of combined tranexamic acid (TA) and&#xD;
      oxytocin infusion with intravenous carbetocin for prevention of PPH in patients with risk&#xD;
      factors during cesarean section.&#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">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 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>A Double-Blind Randomized Clinical Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>A Double-Blind Randomized Clinical Trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The number of the patient need of additional pharmacological uterotonic.</measure>
    <time_frame>24 hours post operative</time_frame>
    <description>calculate the number of the patient 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>24 hours post operative</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>3</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>Carbetocin plus placebo to TA and placebo to oxytocin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 μg carbetocin ampoule or separate placebo ampoule was diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby plus two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oxytocin plus TA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 1gm TA in 100ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby</description>
  </arm_group>
  <arm_group>
    <arm_group_label>oxytocin plus placebo to TA and placebo to carbetocin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbetocin</intervention_name>
    <description>100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby</description>
    <arm_group_label>Carbetocin plus placebo to TA and placebo to oxytocin</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxytocin</intervention_name>
    <description>20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby</description>
    <arm_group_label>oxytocin plus TA</arm_group_label>
    <arm_group_label>oxytocin plus placebo to TA and placebo to carbetocin</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TA</intervention_name>
    <description>2 ampoules of TA in 100 ml saline by slow infusion</description>
    <arm_group_label>oxytocin plus TA</arm_group_label>
    <other_name>active comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to carbetocin</intervention_name>
    <description>placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby</description>
    <arm_group_label>oxytocin plus TA</arm_group_label>
    <arm_group_label>oxytocin plus placebo to TA and placebo to carbetocin</arm_group_label>
    <other_name>placebo comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to TA</intervention_name>
    <description>2 placebo ampoules to TA in 100 ml saline by slow infusion</description>
    <arm_group_label>Carbetocin plus placebo to TA and placebo to oxytocin</arm_group_label>
    <arm_group_label>oxytocin plus placebo to TA and placebo to carbetocin</arm_group_label>
    <other_name>placebo comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to oxytocin</intervention_name>
    <description>two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby</description>
    <arm_group_label>Carbetocin plus placebo to TA and placebo to oxytocin</arm_group_label>
    <other_name>placebo comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who undergo elective cesarean section with one or more risk factors for PPH were&#xD;
             the candidates for participation&#xD;
&#xD;
          -  With fetal macrosomia, polyhydramnios, low insertion of the placenta, multiple&#xD;
             gestations, prolonged labor, chorioamnionitis, past history of PPH, diabetes and high&#xD;
             parity (5 previous deliveries).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suspected coagulopathy,&#xD;
&#xD;
          -  history of coronary artery disease or hypertension,&#xD;
&#xD;
          -  women with a history of hypersensitivity to carbetocin, TA or oxytocin&#xD;
&#xD;
          -  general anesthesia, and&#xD;
&#xD;
          -  PPH due to causes other than uterine atony.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 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 15, 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>oxytocin</keyword>
  <keyword>carbetocin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
    <mesh_term>Carbetocin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03777878
org study id: aswu/186/18
nct id: NCT03777878
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic
      acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean
      section with one or more risk factor for postpartum hemorrhage.
Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor
      to maternal mortality and morbidity especially in developing countries. The risk of PPH is
      much higher for women undergoing cesarean delivery (CD). Oxytocin is regarded as the gold
      standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean
      section oxytocin must be administered as a continuous intravenous infusion to attain
      sustained uterotonic activity throughout the surgical procedure and immediate postpartum
      period. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as
      a single-dose injection; intravenously administered carbetocin has a half-life of
      approximately 40 min.

      A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min
      and persists for an average of 60 min following injection.

      The aim of this study is to compare the effectiveness of combined tranexamic acid (TA) and
      oxytocin infusion with intravenous carbetocin for prevention of PPH in patients with risk
      factors during cesarean section.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A Double-Blind Randomized Clinical Trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: A Double-Blind Randomized Clinical Trial
measure: The number of the patient need of additional pharmacological uterotonic.
time frame: 24 hours post operative
description: calculate the number of the patient 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: 24 hours post operative
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: Carbetocin plus placebo to TA and placebo to oxytocin
arm group type: Active Comparator
description: 100 μg carbetocin ampoule or separate placebo ampoule was diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby plus two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion
arm group label: oxytocin plus TA
arm group type: Active Comparator
description: 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 1gm TA in 100ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
arm group label: oxytocin plus placebo to TA and placebo to carbetocin
arm group type: Active Comparator
description: 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
intervention type: Drug
intervention name: Carbetocin
description: 100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
arm group label: Carbetocin plus placebo to TA and placebo to oxytocin
other name: Active Comparator
intervention type: Drug
intervention name: oxytocin
description: 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
arm group label: oxytocin plus TA
arm group label: oxytocin plus placebo to TA and placebo to carbetocin
other name: Active Comparator
intervention type: Drug
intervention name: TA
description: 2 ampoules of TA in 100 ml saline by slow infusion
arm group label: oxytocin plus TA
other name: active comparator
intervention type: Drug
intervention name: placebo to carbetocin
description: placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
arm group label: oxytocin plus TA
arm group label: oxytocin plus placebo to TA and placebo to carbetocin
other name: placebo comparator
intervention type: Drug
intervention name: placebo to TA
description: 2 placebo ampoules to TA in 100 ml saline by slow infusion
arm group label: Carbetocin plus placebo to TA and placebo to oxytocin
arm group label: oxytocin plus placebo to TA and placebo to carbetocin
other name: placebo comparator
intervention type: Drug
intervention name: placebo to oxytocin
description: two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
arm group label: Carbetocin plus placebo to TA and placebo to oxytocin
other name: placebo comparator
criteria: 
gender: Female
gender based: Yes
gender description: Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
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: Oxytocin
mesh term: Carbetocin