<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/NCT01726478</url>
  </required_header>
  <id_info>
    <org_study_id>OXY168</org_study_id>
    <nct_id>NCT01726478</nct_id>
  </id_info>
  <brief_title>Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital</brief_title>
  <official_title>Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculty of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makerere University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study was to determine whether 2.5 international units of oxytocin gives&#xD;
      adequate uterine tone and is safe as compared to 10 international units of oxytocin following&#xD;
      caesarean section delivery at Mulago hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">April 2011</completion_date>
  <primary_completion_date type="Actual">April 2011</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 adequacy</measure>
    <time_frame>2 minutes</time_frame>
    <description>The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>24 hours</time_frame>
    <description>Blood loss was estimated by measuring the amount in the suction bottles and weighing of the mops. The patients were followed up for any occurrence of postpartum haemorrhage for the next 24 hours after surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">386</enrollment>
  <condition>Adverse Effect of Oxytocic Drugs</condition>
  <condition>Uterine Hemorrhage</condition>
  <condition>Inappropriate Dose of Drug Administered</condition>
  <arm_group>
    <arm_group_label>2.5 units oxytocin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 units oxytocin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of 10 units of oxytocin after clamping of umbilical cord</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2.5 units Oxytocin</intervention_name>
    <description>Administration of 2.5 units of oxytocin after clamping of umbilical cord</description>
    <arm_group_label>2.5 units oxytocin</arm_group_label>
    <other_name>pitocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10 units Oxytocin</intervention_name>
    <description>Administration of 10 units of oxytocin after clamping of umbilical cord</description>
    <arm_group_label>10 units oxytocin</arm_group_label>
    <other_name>pitocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic&#xD;
             disease)&#xD;
&#xD;
          -  Age between 18 to 40 years&#xD;
&#xD;
          -  Singleton pregnancies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Allergy to oxytocin&#xD;
&#xD;
               -  Ruptured uterus&#xD;
&#xD;
               -  Significant obstetric disease (including Pregnancy induced Hypertension,&#xD;
                  Eclampsia,)&#xD;
&#xD;
               -  Known risk factors for postpartum haemorrhage or uterine atony&#xD;
&#xD;
               -  Inherited or acquired coagulation disorder&#xD;
&#xD;
               -  History of post partum haemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Kintu, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makerere University College of Health Sciences Department of Anaesthesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mulago Hospital Labour Suite Operating Theatres</name>
      <address>
        <city>Kampala</city>
        <state>East Africa</state>
        <zip>+256</zip>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Makerere University</investigator_affiliation>
    <investigator_full_name>Faculty of Medicine</investigator_full_name>
    <investigator_title>Dr Andrew Kintu</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>Uterine tone</keyword>
  <keyword>Mulago Hospital</keyword>
  <keyword>Dose</keyword>
  <keyword>Side effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine 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>
  </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/NCT01726478
org study id: OXY168
nct id: NCT01726478
lead sponsor: 
has dmc: Yes
The purpose of the study was to determine whether 2.5 international units of oxytocin gives
      adequate uterine tone and is safe as compared to 10 international units of oxytocin following
      caesarean section delivery at Mulago hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Uterine tone adequacy
time frame: 2 minutes
description: The primary outcome was the assessment of either adequate or inadequate Uterine tone at various times after administration of initial oxytocin dose
measure: Intraoperative blood loss
time frame: 24 hours
description: Blood loss was estimated by measuring the amount in the suction bottles and weighing of the mops. The patients were followed up for any occurrence of postpartum haemorrhage for the next 24 hours after surgery.
arm group label: 2.5 units oxytocin
arm group type: Active Comparator
description: Administration of 2.5 units of oxytocin intravenously after clamping of umbilical cord
arm group label: 10 units oxytocin
arm group type: Placebo Comparator
description: Administration of 10 units of oxytocin after clamping of umbilical cord
intervention type: Drug
intervention name: 2.5 units Oxytocin
description: Administration of 2.5 units of oxytocin after clamping of umbilical cord
arm group label: 2.5 units oxytocin
other name: pitocin
intervention type: Drug
intervention name: 10 units Oxytocin
description: Administration of 10 units of oxytocin after clamping of umbilical cord
arm group label: 10 units oxytocin
other name: pitocin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Kintu, MBChB
role: Principal Investigator
affiliation: Makerere University College of Health Sciences Department of Anaesthesia
facility: 
country: Uganda
responsible party type: Sponsor-Investigator
investigator affiliation: Makerere University
investigator full name: Faculty of Medicine
investigator title: Dr Andrew Kintu
mesh term: Uterine Hemorrhage
mesh term: Hemorrhage
mesh term: Oxytocin