<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/NCT02264769</url>
  </required_header>
  <id_info>
    <org_study_id>14-03</org_study_id>
    <nct_id>NCT02264769</nct_id>
  </id_info>
  <brief_title>Carbetocin at Elective Cesarean Delivery Part 4</brief_title>
  <official_title>Carbetocin at Elective Cesarean Deliveries: A Non-inferiority Study Between 20 and 100 Micrograms - Part 4</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the&#xD;
      most commonly used uterotonic drug to prevent and treat PPH in North America. However&#xD;
      oxytocin has a very short duration of action, requiring a continuous infusion to achieve&#xD;
      sustained uterotonic activity. Moreover large doses are associated with adverse effects like&#xD;
      hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and&#xD;
      Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at&#xD;
      elective cesarean delivery to promote uterine contraction. In three studies recently&#xD;
      performed at Mount Sinai Hospital, the investigators have found no difference in uterine&#xD;
      contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus&#xD;
      a larger trial comparing the minimum effective dose determined in the previous three trials&#xD;
      with the standard 100 mcg dose is necessary to confirm these findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current oxytocin regimen requires the administration of a continuous infusion to achieve&#xD;
      sustained uterotonic activity, which can be associated with a number of side effects and&#xD;
      unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy,&#xD;
      with a similar side effect profile to that of oxytocin. In addition, some studies have also&#xD;
      shown that there is less blood loss and less requirement for additional uterotonic drugs when&#xD;
      carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have&#xD;
      shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin. In the&#xD;
      investigators study, the investigators are going to compare those two doses of carbetocin to&#xD;
      determine that 20 mcg is not inferior to 100 mcg to produce adequate uterine tone in elective&#xD;
      cesarean delivery. This study will be a randomized, double - blind, non inferiority study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uterine tone</measure>
    <time_frame>2 minutes</time_frame>
    <description>Uterine tone on a scale of 0-10 at 2 minutes after completion of injection of carbetocin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uterine tone</measure>
    <time_frame>5 minutes</time_frame>
    <description>Uterine tone on a scale of 0-10 at 5 minutes after completion of injection of carbetocin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional uterotonic medication administration</measure>
    <time_frame>24 hours</time_frame>
    <description>2. The use of additional uterotonic at any time post administration of carbetocin up to 24 hours post delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>48 hours</time_frame>
    <description>Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>2 hours</time_frame>
    <description>Any of the following will be noted up to 2 hours post delivery: systolic blood pressure &lt; 80% of pre-delivery values, tachycardia &gt; 30% pre-delivery levels, bradycardia &lt; 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Carbetocin 20mcg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient is given carbetocin 20 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbetocin 100mcg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient is given carbetocin 100 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbetocin</intervention_name>
    <arm_group_label>Carbetocin 100mcg</arm_group_label>
    <arm_group_label>Carbetocin 20mcg</arm_group_label>
    <other_name>Duratocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective cesarean delivery under spinal anesthesia.&#xD;
&#xD;
          -  Written informed consent to participate in this study.&#xD;
&#xD;
          -  Term pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to give written informed consent.&#xD;
&#xD;
          -  Allergy or hypersensitivity to carbetocin or oxytocin.&#xD;
&#xD;
          -  Conditions that predispose to uterine atony and postpartum hemorrhage, such as&#xD;
             placenta previa, multiple gestation, preeclampsia, eclampsia, macrosomia,&#xD;
             polyhydramnios, uterine fibroids, previous history of uterine atony and postpartum&#xD;
             bleeding, or bleeding diathesis.&#xD;
&#xD;
          -  Hepatic, renal, and vascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Carvalho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>May 22, 2015</last_update_submitted>
  <last_update_submitted_qc>May 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>postpartum hemorrhage</keyword>
  <keyword>Cesarean delivery</keyword>
  <keyword>carbetocin</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>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/NCT02264769
org study id: 14-03
nct id: NCT02264769
lead sponsor: 
has dmc: No
PostPartum hemorrhage (PPH) is a major cause of maternal death worldwide. Oxytocin is the
      most commonly used uterotonic drug to prevent and treat PPH in North America. However
      oxytocin has a very short duration of action, requiring a continuous infusion to achieve
      sustained uterotonic activity. Moreover large doses are associated with adverse effects like
      hypotension, nausea, vomiting, dysrhythmias and ST changes. The Society of Obstetricians and
      Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at
      elective cesarean delivery to promote uterine contraction. In three studies recently
      performed at Mount Sinai Hospital, the investigators have found no difference in uterine
      contractility between the doses of 20- 120 mcg carbetocin and that the ED90 is 14.8 mcg. Thus
      a larger trial comparing the minimum effective dose determined in the previous three trials
      with the standard 100 mcg dose is necessary to confirm these findings.
The current oxytocin regimen requires the administration of a continuous infusion to achieve
      sustained uterotonic activity, which can be associated with a number of side effects and
      unpredictable efficacy. Carbetocin in a single 100 mcg dose has apparently greater efficacy,
      with a similar side effect profile to that of oxytocin. In addition, some studies have also
      shown that there is less blood loss and less requirement for additional uterotonic drugs when
      carbetocin is administered. Studies conducted by the investigators group at Mount Sinai have
      shown similar efficacy between the doses ranging from 20 to 100 mcg of carbetocin. In the
      investigators study, the investigators are going to compare those two doses of carbetocin to
      determine that 20 mcg is not inferior to 100 mcg to produce adequate uterine tone in elective
      cesarean delivery. This study will be a randomized, double - blind, non inferiority study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Uterine tone
time frame: 2 minutes
description: Uterine tone on a scale of 0-10 at 2 minutes after completion of injection of carbetocin.
measure: Uterine tone
time frame: 5 minutes
description: Uterine tone on a scale of 0-10 at 5 minutes after completion of injection of carbetocin.
measure: Additional uterotonic medication administration
time frame: 24 hours
description: 2. The use of additional uterotonic at any time post administration of carbetocin up to 24 hours post delivery.
measure: Blood loss
time frame: 48 hours
description: Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean section.
measure: Side Effects
time frame: 2 hours
description: Any of the following will be noted up to 2 hours post delivery: systolic blood pressure < 80% of pre-delivery values, tachycardia > 30% pre-delivery levels, bradycardia < 30% pre-delivery levels, other dysrhythmias, nausea, vomiting, chest pain, shortness of breath, headache, flushing, others
arm group label: Carbetocin 20mcg
arm group type: Active Comparator
description: Patient is given carbetocin 20 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.
arm group label: Carbetocin 100mcg
arm group type: Active Comparator
description: Patient is given carbetocin 100 mcg intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.
intervention type: Drug
intervention name: Carbetocin
arm group label: Carbetocin 100mcg
arm group label: Carbetocin 20mcg
other name: Duratocin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jose Carvalho, MD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Carbetocin