<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/NCT01719952</url>
  </required_header>
  <id_info>
    <org_study_id>UKMMC</org_study_id>
    <nct_id>NCT01719952</nct_id>
  </id_info>
  <brief_title>Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin</brief_title>
  <official_title>Comparison of Haemodynamic and Cardiovascular Effects of Carbetocin and Oxytocin in Women Undergoing Elective Caesarean Section: A Double-blinded Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Kebangsaan Malaysia Medical Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Kebangsaan Malaysia Medical Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double-blinded randomised control trial conducted in the Department of Obstetrics and&#xD;
      Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for&#xD;
      two years duration from January 1st, 2012 till December 31st, 2013.&#xD;
&#xD;
      The aim of the study is to compare the haemodynamic and cardiovascular effects between&#xD;
      intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective&#xD;
      Lower Segment Caesarean Section (EL LSCS).&#xD;
&#xD;
      Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly&#xD;
      safe and has similar efficacy in comparison to a single injection of oxytocin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate&#xD;
      (HR), saturation of oxygen (SpO2) in certain time after drug injection.&#xD;
&#xD;
      The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such&#xD;
      as ST depression and changes in T-waves.&#xD;
&#xD;
      Hemoglobin and troponin-T level&#xD;
&#xD;
      The need for additional oxytocin infusion and estimated blood loss&#xD;
&#xD;
      The time interval between initial drug administration, type of additional oxytocic&#xD;
      intervention that used and complication that happened.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Haemodynamic effects</measure>
    <time_frame>2 years</time_frame>
    <description>Haemodynamic effect (blood pressure, heart rate, saturation of oxygen)&#xD;
Presence of ECG changes such as ST depression and changes in T-waves&#xD;
Presence of myocardial ischemia symptoms (such as chest pain, shortness of breath, feeling of heaviness in chest pain)&#xD;
To compare the troponin T levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood loss measurement</measure>
    <time_frame>2 years</time_frame>
    <description>Need for additional oxytocin infusion&#xD;
Total blood loss&#xD;
Drop in haemoglobin level post-operatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Carbetocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Other names are Pitocin, syntocinon given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbetocin</intervention_name>
    <description>IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.&#xD;
pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.</description>
    <arm_group_label>Carbetocin</arm_group_label>
    <other_name>Duratocin for carbetocin</other_name>
    <other_name>pitocin for oxytocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>pitocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Viable, singleton pregnancy ≥ 37 weeks gestation undergoing EL LSCS.&#xD;
&#xD;
          2. Low risk for post-partum hemorrhage, such as no proven abruptio placentae, placenta&#xD;
             previa, multiple pregnancy, pre-eclampsia / gestational hypertension, previous PPH,&#xD;
             obesity (based on BMI pre pregnancy which is ≥ 30 kg/m2), big baby.&#xD;
&#xD;
          3. Ability to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Emergency caesarean section&#xD;
&#xD;
          2. Preterm Labour&#xD;
&#xD;
          3. Grandmultipara&#xD;
&#xD;
          4. Multiple Pregnancy&#xD;
&#xD;
          5. Placenta Previa&#xD;
&#xD;
          6. Previous PPH&#xD;
&#xD;
          7. Maternal Obesity ( BMI pre pregnancy ≥ 30 kg/m2))&#xD;
&#xD;
          8. Have co-morbidity illness such as hypertension/pre-eclampsia, established cardiac&#xD;
             diseases, history or evidence of liver, renal, vascular, or endocrine disease and&#xD;
             bleeding disorder.&#xD;
&#xD;
          9. Contraindication to carbetocin and oxytocin&#xD;
&#xD;
         10. Language Barrier&#xD;
&#xD;
         11. Women undergoing general anaesthesia&#xD;
&#xD;
         12. Women who has abnormal baseline ECG that suggestive myocardial ischemia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nirmala C Kampan, MRCOG(UK)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Kebangsaan Malaysia Medical Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of O&amp;G</name>
      <address>
        <city>Cheras</city>
        <state>Kuala Lumpur</state>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>February 26, 2015</last_update_submitted>
  <last_update_submitted_qc>February 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Kebangsaan Malaysia Medical Centre</investigator_affiliation>
    <investigator_full_name>Nirmala Chandralega Kampan</investigator_full_name>
    <investigator_title>MRCOG(UK)</investigator_title>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>anaesthesia</keyword>
  <keyword>caesarean section</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/NCT01719952
org study id: UKMMC
nct id: NCT01719952
lead sponsor: 
has dmc: Yes
A double-blinded randomised control trial conducted in the Department of Obstetrics and
      Gynaecology of a tertiary hospital, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for
      two years duration from January 1st, 2012 till December 31st, 2013.

      The aim of the study is to compare the haemodynamic and cardiovascular effects between
      intravenous carbetocin 100 μg and intravenous oxytocin 5 IU in women undergoing elective
      Lower Segment Caesarean Section (EL LSCS).

      Study hypothesis: A single injection of carbetocin is haemodynamically and cardiovascularly
      safe and has similar efficacy in comparison to a single injection of oxytocin.
OUTCOME MEASURES systolic blood pressure (SBP), diastolic blood pressure (DBP), Heart Rate
      (HR), saturation of oxygen (SpO2) in certain time after drug injection.

      The presence of myocardial ischemia symptoms and side effects of both drugs, ECG changes such
      as ST depression and changes in T-waves.

      Hemoglobin and troponin-T level

      The need for additional oxytocin infusion and estimated blood loss

      The time interval between initial drug administration, type of additional oxytocic
      intervention that used and complication that happened.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Haemodynamic effects
time frame: 2 years
description: Haemodynamic effect (blood pressure, heart rate, saturation of oxygen)
Presence of ECG changes such as ST depression and changes in T-waves
Presence of myocardial ischemia symptoms (such as chest pain, shortness of breath, feeling of heaviness in chest pain)
To compare the troponin T levels
measure: Blood loss measurement
time frame: 2 years
description: Need for additional oxytocin infusion
Total blood loss
Drop in haemoglobin level post-operatively
arm group label: Carbetocin
arm group type: Experimental
description: Carbetocin 100 µg, given as an intravenous bolus over 30 seconds others names are: duratocin, pabal
arm group label: Oxytocin
arm group type: Active Comparator
description: Other names are Pitocin, syntocinon given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
intervention type: Drug
intervention name: Carbetocin
description: IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
arm group label: Carbetocin
other name: Duratocin for carbetocin
other name: pitocin for oxytocin
intervention type: Drug
intervention name: Oxytocin
description: 5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
arm group label: Oxytocin
other name: pitocin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Nirmala C Kampan, MRCOG(UK)
role: Principal Investigator
affiliation: Universiti Kebangsaan Malaysia Medical Centre
facility: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Universiti Kebangsaan Malaysia Medical Centre
investigator full name: Nirmala Chandralega Kampan
investigator title: MRCOG(UK)
mesh term: Oxytocin
mesh term: Carbetocin