<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/NCT02221531</url>
  </required_header>
  <id_info>
    <org_study_id>2014-088</org_study_id>
    <nct_id>NCT02221531</nct_id>
  </id_info>
  <brief_title>Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between Tonus (TOnus) and CIrculatioN</brief_title>
  <acronym>CARBETOCIN</acronym>
  <official_title>Double-blind Randomised Non-inferiority Trial to Assess Efficacy and Safety of Carbetocin After Caesarean Section Applied as Iv-bolus as Compared to a Short-infusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Obstetric Anaesthetists' Association United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml&#xD;
      after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood&#xD;
      transfusion within 24 hours after delivery (World Health Organization, Recommendations for&#xD;
      the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009).&#xD;
      Since PPH is more common after caesarean deliveries than after vaginal births and the rate of&#xD;
      CS is rising over time and will probably continue to rise, the incidence of PPH is expected&#xD;
      to increase accordingly.&#xD;
&#xD;
      A meta-analysis has shown that routine administration of an oxytocic agent after caesarean&#xD;
      delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane&#xD;
      Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery&#xD;
      are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over&#xD;
      oxytocin of having a longer half-life and therefore reducing the use of additional&#xD;
      uterotonics. Based on the findings of reduced cardiovascular side-effects with a&#xD;
      short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J&#xD;
      Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin&#xD;
      minimises the cardiovascular side effects without compromising the uterine tone. Therefore,&#xD;
      we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid&#xD;
      compared to a bolus application in women undergoing primary or secondary caesarean delivery.&#xD;
      This prospective, double-blind, randomised controlled non-inferiority trial will take place&#xD;
      at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be&#xD;
      inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a&#xD;
      short-infusion than after a bolus administration (primary safety endpoint).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 4</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>Maximal uterine tone</measure>
    <time_frame>within the first 5 minutes after cord clamping</time_frame>
    <description>Uterine tone is assessed by the obstetrician on a linear analogue scale from 0 to 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean arterial pressure</measure>
    <time_frame>within first five minutes after cord clamping</time_frame>
    <description>mean arterial pressure is measured by a non-invasive blood pressure cuff at the upper arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Complications; Cesarean Section</condition>
  <condition>Anesthesia; Reaction</condition>
  <arm_group>
    <arm_group_label>Short infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bolus application</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Carbetocin 100 microgram will be applied intravenously by bolus application over about 15 seconds</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbetocin Short-infusion</intervention_name>
    <description>Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method)</description>
    <arm_group_label>Short infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbetocin Bolus application</intervention_name>
    <description>Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds</description>
    <arm_group_label>Bolus application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy women&#xD;
&#xD;
          -  singleton pregnancy&#xD;
&#xD;
          -  caesarean section under regional anaesthesia&#xD;
&#xD;
          -  older than 18 years&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency caesarean section&#xD;
&#xD;
          -  secondary caesarean section due to fetal distress&#xD;
&#xD;
          -  comorbidities (cardiovascular, kidney or liver disorder, epilepsy)&#xD;
&#xD;
          -  obstetric diseases (hypertension, (pre-)eclampsia)&#xD;
&#xD;
          -  uterine malformation (including uterine fibroids)&#xD;
&#xD;
          -  bleeding disorder&#xD;
&#xD;
          -  known hypersensitivity to carbetocin or oxytocin&#xD;
&#xD;
          -  fetal malformation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salome Dell-Kuster, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology, University Hospital Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carbetocin</mesh_term>
    <mesh_term>Oxytocin</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/NCT02221531
org study id: 2014-088
nct id: NCT02221531
lead sponsor: 
collaborator: 
has dmc: Yes
Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml
      after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood
      transfusion within 24 hours after delivery (World Health Organization, Recommendations for
      the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009).
      Since PPH is more common after caesarean deliveries than after vaginal births and the rate of
      CS is rising over time and will probably continue to rise, the incidence of PPH is expected
      to increase accordingly.

      A meta-analysis has shown that routine administration of an oxytocic agent after caesarean
      delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane
      Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery
      are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over
      oxytocin of having a longer half-life and therefore reducing the use of additional
      uterotonics. Based on the findings of reduced cardiovascular side-effects with a
      short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J
      Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin
      minimises the cardiovascular side effects without compromising the uterine tone. Therefore,
      we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid
      compared to a bolus application in women undergoing primary or secondary caesarean delivery.
      This prospective, double-blind, randomised controlled non-inferiority trial will take place
      at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be
      inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a
      short-infusion than after a bolus administration (primary safety endpoint).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Maximal uterine tone
time frame: within the first 5 minutes after cord clamping
description: Uterine tone is assessed by the obstetrician on a linear analogue scale from 0 to 100
measure: Mean arterial pressure
time frame: within first five minutes after cord clamping
description: mean arterial pressure is measured by a non-invasive blood pressure cuff at the upper arm
arm group label: Short infusion
arm group type: Experimental
description: Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute
arm group label: Bolus application
arm group type: Other
description: Carbetocin 100 microgram will be applied intravenously by bolus application over about 15 seconds
intervention type: Drug
intervention name: Carbetocin Short-infusion
description: Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method)
arm group label: Short infusion
intervention type: Drug
intervention name: Carbetocin Bolus application
description: Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds
arm group label: Bolus application
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: No
last name: Salome Dell-Kuster, MD
role: Principal Investigator
affiliation: Department of Anaesthesiology, University Hospital Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Carbetocin
mesh term: Oxytocin