<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/NCT01689298</url>
  </required_header>
  <id_info>
    <org_study_id>12-05</org_study_id>
    <secondary_id>11-0257-E</secondary_id>
    <nct_id>NCT01689298</nct_id>
  </id_info>
  <brief_title>Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment</brief_title>
  <official_title>Carbetocin vs. Oxytocin: In-vitro Myometrial Contractions With and Without Oxytocin Pre-treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the ability of an isolated sample of uterine muscle&#xD;
      tissue (in a tissue bath) to contract in the presence of various drugs. The drugs&#xD;
      studied--uterotonics--are typically used to contract the uterus when a pregnant patient&#xD;
      continues to bleed after delivery. Oxytocin is an old standard, but seems to suffer from a&#xD;
      desensitization phenomenon. Carbetocin, a similar drug, has recently been suggested to&#xD;
      clinicians as a replacement for oxytocin directly after certain types of Cesarean section.&#xD;
&#xD;
      The investigators will be testing isolated uterine muscle samples after pre-treatment with&#xD;
      oxytocin OR nothing (control) to increasing concentrations of oxytocin OR carbetocin.&#xD;
      Contractile measures will be measured and compared between all groups. The investigators&#xD;
      hypothesize that oxytocin pre-treatment will reduce contractions in both oxytocin- and&#xD;
      carbetocin-induced contractions, and oxytocin and carbetocin will induce different patterns&#xD;
      of contractions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80%&#xD;
      cases of PPH, the primary cause is failure of the uterus to contract after delivery of the&#xD;
      baby, which then requires further treatment of the mother with uterotonic drugs (drugs used&#xD;
      to contract uterus and thus prevent bleeding).&#xD;
&#xD;
      Patients participating in this study will be asked to donate a very small sample of uterine&#xD;
      tissue during Cesarean section, which will be tested in the laboratory for the ability to&#xD;
      contract in response to the uterotonics oxytocin and carbetocin. We will seek to better&#xD;
      understand the effects of these drugs by comparing their contractile capability in isolated&#xD;
      uterine tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amplitude of contraction</measure>
    <time_frame>6-8 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Integrated area under response curve (AUC)</measure>
    <time_frame>6-8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal tone</measure>
    <time_frame>6-8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of contraction</measure>
    <time_frame>6-8 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>No drug pre-treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A control sample from each patient (no uterotonic drug will be applied during pre-treatment) will be measured concurrently with samples pre-treated with oxytocin. Controls will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given oxytocin for pre-treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug pre-treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A sample from each patient will be pre-treated with oxytocin 10-5mol/L. These samples will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given no drug for pre-treatment (controls).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.</description>
    <arm_group_label>Drug pre-treatment</arm_group_label>
    <arm_group_label>No drug pre-treatment</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbetocin</intervention_name>
    <description>Carbetocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.</description>
    <arm_group_label>Drug pre-treatment</arm_group_label>
    <arm_group_label>No drug pre-treatment</arm_group_label>
    <other_name>Duratocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age 37-41 weeks&#xD;
&#xD;
          -  Non-laboring patients, not exposed to exogenous oxytocin&#xD;
&#xD;
          -  Patients requiring primary or first repeat Cesarean section&#xD;
&#xD;
          -  Cesarean section under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who require general anesthesia&#xD;
&#xD;
          -  Patient who had previous myometrial surgery or more than one previous Cesarean section&#xD;
&#xD;
          -  Patients with placental anomalies&#xD;
&#xD;
          -  Emergency Cesarean section in labor&#xD;
&#xD;
          -  Patients with multiple pregnancy (twins, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mrinalini Balki, 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>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 17, 2012</last_update_submitted>
  <last_update_submitted_qc>September 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Uterine contraction</keyword>
  <keyword>Dose response</keyword>
  <keyword>Oxytocin pretreatment</keyword>
  <keyword>Oxytocin</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>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/NCT01689298
org study id: 12-05
secondary id: 11-0257-E
nct id: NCT01689298
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the ability of an isolated sample of uterine muscle
      tissue (in a tissue bath) to contract in the presence of various drugs. The drugs
      studied--uterotonics--are typically used to contract the uterus when a pregnant patient
      continues to bleed after delivery. Oxytocin is an old standard, but seems to suffer from a
      desensitization phenomenon. Carbetocin, a similar drug, has recently been suggested to
      clinicians as a replacement for oxytocin directly after certain types of Cesarean section.

      The investigators will be testing isolated uterine muscle samples after pre-treatment with
      oxytocin OR nothing (control) to increasing concentrations of oxytocin OR carbetocin.
      Contractile measures will be measured and compared between all groups. The investigators
      hypothesize that oxytocin pre-treatment will reduce contractions in both oxytocin- and
      carbetocin-induced contractions, and oxytocin and carbetocin will induce different patterns
      of contractions.
Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80%
      cases of PPH, the primary cause is failure of the uterus to contract after delivery of the
      baby, which then requires further treatment of the mother with uterotonic drugs (drugs used
      to contract uterus and thus prevent bleeding).

      Patients participating in this study will be asked to donate a very small sample of uterine
      tissue during Cesarean section, which will be tested in the laboratory for the ability to
      contract in response to the uterotonics oxytocin and carbetocin. We will seek to better
      understand the effects of these drugs by comparing their contractile capability in isolated
      uterine tissue.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Amplitude of contraction
time frame: 6-8 hours
measure: Integrated area under response curve (AUC)
time frame: 6-8 hours
measure: Basal tone
time frame: 6-8 hours
measure: Frequency of contraction
time frame: 6-8 hours
arm group label: No drug pre-treatment
arm group type: Active Comparator
description: A control sample from each patient (no uterotonic drug will be applied during pre-treatment) will be measured concurrently with samples pre-treated with oxytocin. Controls will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given oxytocin for pre-treatment.
arm group label: Drug pre-treatment
arm group type: Active Comparator
description: A sample from each patient will be pre-treated with oxytocin 10-5mol/L. These samples will undergo the same dose response of oxytocin or carbetocin after pre-treatment period as the groups given no drug for pre-treatment (controls).
intervention type: Drug
intervention name: Oxytocin
description: Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
arm group label: Drug pre-treatment
arm group label: No drug pre-treatment
other name: Pitocin
intervention type: Drug
intervention name: Carbetocin
description: Carbetocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
arm group label: Drug pre-treatment
arm group label: No drug pre-treatment
other name: Duratocin
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mrinalini Balki, MD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Oxytocin
mesh term: Carbetocin