<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/NCT01689311</url>
  </required_header>
  <id_info>
    <org_study_id>12-06</org_study_id>
    <secondary_id>09-0053-E</secondary_id>
    <nct_id>NCT01689311</nct_id>
  </id_info>
  <brief_title>In Vitro Myometrial Contractions in Laboring and Non-laboring Women</brief_title>
  <official_title>In Vitro Myometrial Contractions in Laboring and Non-laboring Women: Oxytocin is Superior to Other Uterotonic Agents</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>
    <collaborator>
      <agency>Canadian Anesthesiologists' Society</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. Amongst common uterotonic drugs, namely oxytocin,&#xD;
      ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.&#xD;
&#xD;
      The investigators will be testing isolated uterine muscle samples to increasing&#xD;
      concentrations of these four drugs in three patient populations: non-laboring, laboring&#xD;
      without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile&#xD;
      measures will be measured and compared between all groups. The investigators hypothesize that&#xD;
      oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients,&#xD;
      and all four drugs will induce different patterns 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, ergonovine, prostaglandin F2alpha, and&#xD;
      misoprostol. We will seek to better understand the effects of these drugs by comparing their&#xD;
      contractile capability in isolated uterine tissue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group 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>4-5 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Integrated area under response curve (AUC)</measure>
    <time_frame>4-5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal tone</measure>
    <time_frame>4-5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of contraction</measure>
    <time_frame>4-5 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.</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>Treatment</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ergonovine</intervention_name>
    <description>Ergonovine, 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>Treatment</arm_group_label>
    <other_name>Ergot</other_name>
    <other_name>Ergometrine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prostaglandin F2alpha</intervention_name>
    <description>Prostaglandin F2alpha, 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>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Misoprostol</intervention_name>
    <description>Misoprostol, 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>Treatment</arm_group_label>
    <other_name>Synthetic prostaglandin E1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age 37-41 weeks&#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;
          -  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 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 20, 2012</last_update_submitted>
  <last_update_submitted_qc>September 20, 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>Non-laboring</keyword>
  <keyword>Laboring</keyword>
  <keyword>Laboring with oxytocin augmentation</keyword>
  <keyword>Oxytocin</keyword>
  <keyword>Ergonovine</keyword>
  <keyword>Prostaglandin F2alpha</keyword>
  <keyword>Misoprostol</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>Alprostadil</mesh_term>
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Oxytocin</mesh_term>
    <mesh_term>Ergonovine</mesh_term>
    <mesh_term>Dinoprost</mesh_term>
    <mesh_term>Dinoprost tromethamine</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/NCT01689311
org study id: 12-06
secondary id: 09-0053-E
nct id: NCT01689311
lead sponsor: 
collaborator: 
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. Amongst common uterotonic drugs, namely oxytocin,
      ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.

      The investigators will be testing isolated uterine muscle samples to increasing
      concentrations of these four drugs in three patient populations: non-laboring, laboring
      without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile
      measures will be measured and compared between all groups. The investigators hypothesize that
      oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients,
      and all four drugs 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, ergonovine, prostaglandin F2alpha, and
      misoprostol. We will seek to better understand the effects of these drugs by comparing their
      contractile capability in isolated uterine tissue.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Amplitude of contraction
time frame: 4-5 hours
measure: Integrated area under response curve (AUC)
time frame: 4-5 hours
measure: Basal tone
time frame: 4-5 hours
measure: Frequency of contraction
time frame: 4-5 hours
arm group label: Treatment
arm group type: Experimental
description: All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol.
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: Treatment
other name: Pitocin
intervention type: Drug
intervention name: Ergonovine
description: Ergonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
arm group label: Treatment
other name: Ergot
other name: Ergometrine
intervention type: Drug
intervention name: Prostaglandin F2alpha
description: Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
arm group label: Treatment
intervention type: Drug
intervention name: Misoprostol
description: Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
arm group label: Treatment
other name: Synthetic prostaglandin E1
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: Alprostadil
mesh term: Misoprostol
mesh term: Oxytocin
mesh term: Ergonovine
mesh term: Dinoprost
mesh term: Dinoprost tromethamine