<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/NCT02216383</url>
  </required_header>
  <id_info>
    <org_study_id>3344</org_study_id>
    <secondary_id>2014-001948-37</secondary_id>
    <nct_id>NCT02216383</nct_id>
  </id_info>
  <brief_title>Intramuscular Oxytocics: A Randomised Control Trial</brief_title>
  <acronym>IMox</acronym>
  <official_title>Intramuscular Oxytocics: A Randomised Control Trial of Intramuscular Carbetocin, Syntocinon and Syntometrine for the Third Stage of Labour Following Vaginal Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Bristol NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bristol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of the West of England</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal United Hospital Bath NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gloucestershire Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospitals Bristol and Weston NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>North Bristol NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A quarter of all pregnancy and child-birth related deaths are due to excessive bleeding after&#xD;
      the birth, &quot;post-partum haemorrhage&quot; (PPH). In the UK, PPH affects approx 10% of new mothers.&#xD;
      PPH can be frightening for women and cause them to need additional treatments prolonging&#xD;
      their hospital stay.&#xD;
&#xD;
      Commonly PPH is caused by an inadequately contracted womb after childbirth. Giving the mother&#xD;
      an injection of &quot;uterotonic&quot; medicine following the birth of their baby can prevent this. It&#xD;
      reduces the risk of PPH by 66%.&#xD;
&#xD;
      In the UK, the two medicines most commonly used are Syntocinon and Syntometrine. Syntometrine&#xD;
      is longer acting, but a published review of trials concluded that Syntometrine is no better&#xD;
      at preventing severe blood loss. Syntometrine is associated with more side effects including&#xD;
      nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of&#xD;
      stroke. All guidelines therefore recommend Syntocinon for preventing PPH.Following a&#xD;
      telephone survey of all maternity units in the UK, 71.4% of units still routinely use&#xD;
      Syntometrine.&#xD;
&#xD;
      Carbetocin is a newer medicine, already widely used after caesarean section, but not yet&#xD;
      after vaginal birth. Other studies have shown that Carbetocin is slightly better at&#xD;
      preventing bleeding after birth when compared to Syntometrine, has fewer side effects than&#xD;
      Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No studies&#xD;
      have directly compared all three medicines or compared their overall cost; information vital&#xD;
      to the NHS.&#xD;
&#xD;
      Investigators propose a trial of 5712 women over 13 months, in four maternity units to&#xD;
      compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin,&#xD;
      for women having a vaginal birth.&#xD;
&#xD;
      Women will be randomly allocated to receive one of these drugs. Women and staff will not know&#xD;
      which drug they receive. Staff will collect data such as the number of extra drugs and&#xD;
      treatments needed and the volume of blood lost. Women will be asked to complete a side&#xD;
      effects questionnaire. Investigators will perform an analysis of cost effectiveness once all&#xD;
      results are available.&#xD;
&#xD;
      Aim: To directly compare the effectiveness, side effects and cost of Syntocinon, Syntometrine&#xD;
      and Carbetocin given intramuscularly to prevent PPH in the 3rd stage of labour.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND Around a quarter of all global pregnancy and child-birth related deaths are due to&#xD;
      excessive bleeding after the birth of the baby and placenta, or &quot;post-partum haemorrhage&quot;&#xD;
      (PPH). In the UK, PPH affects approximately 10% of new mothers. PPH can be extremely&#xD;
      frightening for women and can cause them to need additional treatments including blood&#xD;
      transfusion and removal of the womb as well as prolonging their hospital stay.&#xD;
&#xD;
      The most common cause of PPH is an inadequately contracted womb after childbirth. Giving the&#xD;
      mother an injection of &quot;uterotonic&quot; medicine following the birth of their baby can prevent&#xD;
      this. It reduces the risk of PPH by 66% and this should routinely be offered to all labouring&#xD;
      women.&#xD;
&#xD;
      In the UK, the two medicines most commonly used for this purpose are Syntocinon and&#xD;
      Syntometrine. Both mimic natural hormones. Syntometrine is longer acting, but a published&#xD;
      review of trials comparing these two medicines concluded that Syntometrine is no better at&#xD;
      preventing severe blood loss. Syntometrine is associated with more side effects including&#xD;
      nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of&#xD;
      stroke. All guidelines therefore recommend Syntocinon for preventing PPH.&#xD;
&#xD;
      Our group conducted a telephone survey of all maternity units in the UK, and found that 71.4%&#xD;
      of units still routinely use Syntometrine. Investigators estimate that 40,000-70,000 women&#xD;
      per year are experiencing distressing nausea and vomiting in the emotionally important first&#xD;
      few hours following childbirth. These women are also receiving a medicine with the potential&#xD;
      to cause dangerous high blood pressure.&#xD;
&#xD;
      Carbetocin is a newer medicine, already widely used after caesarean section, but not yet&#xD;
      after vaginal birth. Other studies have shown that Carbetocin is slightly better at&#xD;
      preventing bleeding after birth when compared to Syntometrine, that it has fewer side effects&#xD;
      than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No&#xD;
      studies have directly compared all three medicines or compared their overall cost;&#xD;
      information vital to the NHS.&#xD;
&#xD;
      METHOD Investigators propose a trial of 5712 women over 13 months, in four maternity units in&#xD;
      the South-West to compare the effectiveness, side effects and cost of Syntocinon,&#xD;
      Syntometrine and Carbetocin, for women having a vaginal birth.&#xD;
&#xD;
      Women will be randomly allocated to receive one of these drugs. Women and staff will not know&#xD;
      which drug they receive, so as not to influence the results collected. Staff will collect&#xD;
      data such as the number of extra drugs and treatments needed and the volume of blood lost.&#xD;
      Women will be asked to complete a side effects questionnaire. Investigators will perform an&#xD;
      analysis of cost effectiveness once all results are available.&#xD;
&#xD;
      AIMS To directly compare the effectiveness, side effects and cost of Syntocinon, Syntometrine&#xD;
      and Carbetocin given intramuscularly to prevent PPH in the 3rd stage of labour.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Requirement for additional uterotonic drugs within 24 hours of birth</measure>
    <time_frame>From administration of prophylactic uterotonic agent to discharge from labour ward, within an expected average of 6 hours.</time_frame>
    <description>Proportion of patients requiring additional uterotonic drugs after administration of study drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated volume of blood loss at delivery</measure>
    <time_frame>Within 24 hours of delivery</time_frame>
    <description>Estimated volume of blood loss at delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion of blood products (type and number of units given)</measure>
    <time_frame>From delivery until transfer from Labour Ward, within an expected average of 6 hours.</time_frame>
    <description>Number of units of blood transfused, or volume of own blood returned to patient if intraoperative cell salvage used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual removal of placenta in theatre</measure>
    <time_frame>From delivery until transfer from Labour Ward</time_frame>
    <description>The requirement for the placenta to be removed in theatre</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirement for surgical intervention to manage PPH</measure>
    <time_frame>From delivery until transfer from Labour Ward, within an expected average of 2 days</time_frame>
    <description>As a result of significant PPH a surgical intervention was required to manage the PPH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal hypertension</measure>
    <time_frame>First two postnatal hours following administration of study drug</time_frame>
    <description>Hypertension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal hypotension</measure>
    <time_frame>In first two postnatal hours</time_frame>
    <description>BP &lt;90/60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternally-reported health-related quality of life</measure>
    <time_frame>24 hours after delivery and 14 days after delivery</time_frame>
    <description>health-related quality of life reported by mother</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal pain in the first two postnatal hours, recorded in Case Report Form (CRF) by midwife</measure>
    <time_frame>First 2 post natal hours</time_frame>
    <description>Patient reported secondary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-partum vomiting</measure>
    <time_frame>First 2 post natal hours</time_frame>
    <description>Patient reported secondary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for anti-emetic</measure>
    <time_frame>First 2 post natal hours</time_frame>
    <description>Patient reported secondary outcome&#xD;
By definition, labour starts when the patient is at least 3-4cm dilated with regular, painful contractions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache</measure>
    <time_frame>First two post natal hours</time_frame>
    <description>Patient reported secondary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal experience of side effects</measure>
    <time_frame>In first two post natal hours</time_frame>
    <description>Captured using maternal side effects questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5798</enrollment>
  <condition>Post Partum Haemorrhage</condition>
  <arm_group>
    <arm_group_label>Carbetocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of 100 micrograms intramuscular Carbetocin given for active management of the third stage of labour, immediately after the birth of the baby</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Syntocinon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One dose of 10 International Units intramuscular Syntocinon given for active management of the third stage of labour, immediately after the birth of the baby</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Syntometrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One dose of 500micrograms/5 International Units intramuscular Syntometrine given for active management of the third stage of labour, immediately after the birth of the baby</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carbetocin</intervention_name>
    <description>The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Carbetocin, listed here, is one of the of the three study drugs.</description>
    <arm_group_label>Carbetocin</arm_group_label>
    <other_name>Pabal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Syntocinon</intervention_name>
    <description>The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntocinon, listed here, is one of the of the three study drugs.</description>
    <arm_group_label>Syntocinon</arm_group_label>
    <other_name>Oxytocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Syntometrine</intervention_name>
    <description>The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntometrine, listed here, is one of the of the three study drugs.</description>
    <arm_group_label>Syntometrine</arm_group_label>
    <other_name>Syntometrine 500 micrograms/5 IU Solution for Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age at time of delivery&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Vaginal birth (spontaneous and instrumental)&#xD;
&#xD;
          -  &gt;24 weeks gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant APH (&gt;50ml) or suspected or proven placenta abruption&#xD;
&#xD;
          -  Maternal coagulation disorder&#xD;
&#xD;
          -  Intrauterine fetal death&#xD;
&#xD;
          -  Patients who would decline blood products if required&#xD;
&#xD;
          -  Known or suspected hypertensive disorders, including pre-eclampsia, pregnancy induced&#xD;
             hypertension, essential hypertension (even if blood pressure well controlled)&#xD;
&#xD;
          -  Hypertension in labour, or patients who have not had their blood pressure checked in&#xD;
             labour&#xD;
&#xD;
          -  Patients with peripheral, hepatic or cardiac disease&#xD;
&#xD;
          -  Patients with an allergy or hypersensitivity to any of the active ingredients in&#xD;
             Carbetocin, Syntometrine or Syntocinon&#xD;
&#xD;
          -  Epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tim Draycott, BMBS</last_name>
    <role>Study Director</role>
    <affiliation>North Bristol NHS Trust/University of Bristol</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helen van der Nelson, BMBS</last_name>
    <role>Study Chair</role>
    <affiliation>North Bristol NHS Trust/University of Bristol</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Bristol NHS Trust</name>
      <address>
        <city>Bristol</city>
        <state>Avon</state>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Hospitals NHS Trust</name>
      <address>
        <city>Gloucester</city>
        <state>Gloucestershire</state>
        <zip>GL1 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospital NHS Trust</name>
      <address>
        <city>Bath</city>
        <state>Somerset</state>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Western Hospital</name>
      <address>
        <city>Swindon</city>
        <zip>SN3 6BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Post partum haemorrhage</keyword>
  <keyword>Active Management of Third Stage of Labour</keyword>
  <keyword>Carbetocin</keyword>
  <keyword>Syntocinon</keyword>
  <keyword>Syntometrine</keyword>
  <keyword>Birth experience</keyword>
  <keyword>Labour</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>
    <mesh_term>Syntometrine</mesh_term>
    <mesh_term>Ergonovine</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/NCT02216383
org study id: 3344
secondary id: 2014-001948-37
nct id: NCT02216383
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
A quarter of all pregnancy and child-birth related deaths are due to excessive bleeding after
      the birth, "post-partum haemorrhage" (PPH). In the UK, PPH affects approx 10% of new mothers.
      PPH can be frightening for women and cause them to need additional treatments prolonging
      their hospital stay.

      Commonly PPH is caused by an inadequately contracted womb after childbirth. Giving the mother
      an injection of "uterotonic" medicine following the birth of their baby can prevent this. It
      reduces the risk of PPH by 66%.

      In the UK, the two medicines most commonly used are Syntocinon and Syntometrine. Syntometrine
      is longer acting, but a published review of trials concluded that Syntometrine is no better
      at preventing severe blood loss. Syntometrine is associated with more side effects including
      nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of
      stroke. All guidelines therefore recommend Syntocinon for preventing PPH.Following a
      telephone survey of all maternity units in the UK, 71.4% of units still routinely use
      Syntometrine.

      Carbetocin is a newer medicine, already widely used after caesarean section, but not yet
      after vaginal birth. Other studies have shown that Carbetocin is slightly better at
      preventing bleeding after birth when compared to Syntometrine, has fewer side effects than
      Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No studies
      have directly compared all three medicines or compared their overall cost; information vital
      to the NHS.

      Investigators propose a trial of 5712 women over 13 months, in four maternity units to
      compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin,
      for women having a vaginal birth.

      Women will be randomly allocated to receive one of these drugs. Women and staff will not know
      which drug they receive. Staff will collect data such as the number of extra drugs and
      treatments needed and the volume of blood lost. Women will be asked to complete a side
      effects questionnaire. Investigators will perform an analysis of cost effectiveness once all
      results are available.

      Aim: To directly compare the effectiveness, side effects and cost of Syntocinon, Syntometrine
      and Carbetocin given intramuscularly to prevent PPH in the 3rd stage of labour.
BACKGROUND Around a quarter of all global pregnancy and child-birth related deaths are due to
      excessive bleeding after the birth of the baby and placenta, or "post-partum haemorrhage"
      (PPH). In the UK, PPH affects approximately 10% of new mothers. PPH can be extremely
      frightening for women and can cause them to need additional treatments including blood
      transfusion and removal of the womb as well as prolonging their hospital stay.

      The most common cause of PPH is an inadequately contracted womb after childbirth. Giving the
      mother an injection of "uterotonic" medicine following the birth of their baby can prevent
      this. It reduces the risk of PPH by 66% and this should routinely be offered to all labouring
      women.

      In the UK, the two medicines most commonly used for this purpose are Syntocinon and
      Syntometrine. Both mimic natural hormones. Syntometrine is longer acting, but a published
      review of trials comparing these two medicines concluded that Syntometrine is no better at
      preventing severe blood loss. Syntometrine is associated with more side effects including
      nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of
      stroke. All guidelines therefore recommend Syntocinon for preventing PPH.

      Our group conducted a telephone survey of all maternity units in the UK, and found that 71.4%
      of units still routinely use Syntometrine. Investigators estimate that 40,000-70,000 women
      per year are experiencing distressing nausea and vomiting in the emotionally important first
      few hours following childbirth. These women are also receiving a medicine with the potential
      to cause dangerous high blood pressure.

      Carbetocin is a newer medicine, already widely used after caesarean section, but not yet
      after vaginal birth. Other studies have shown that Carbetocin is slightly better at
      preventing bleeding after birth when compared to Syntometrine, that it has fewer side effects
      than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No
      studies have directly compared all three medicines or compared their overall cost;
      information vital to the NHS.

      METHOD Investigators propose a trial of 5712 women over 13 months, in four maternity units in
      the South-West to compare the effectiveness, side effects and cost of Syntocinon,
      Syntometrine and Carbetocin, for women having a vaginal birth.

      Women will be randomly allocated to receive one of these drugs. Women and staff will not know
      which drug they receive, so as not to influence the results collected. Staff will collect
      data such as the number of extra drugs and treatments needed and the volume of blood lost.
      Women will be asked to complete a side effects questionnaire. Investigators will perform an
      analysis of cost effectiveness once all results are available.

      AIMS To directly compare the effectiveness, side effects and cost of Syntocinon, Syntometrine
      and Carbetocin given intramuscularly to prevent PPH in the 3rd stage of labour.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Requirement for additional uterotonic drugs within 24 hours of birth
time frame: From administration of prophylactic uterotonic agent to discharge from labour ward, within an expected average of 6 hours.
description: Proportion of patients requiring additional uterotonic drugs after administration of study drug
measure: Estimated volume of blood loss at delivery
time frame: Within 24 hours of delivery
description: Estimated volume of blood loss at delivery
measure: Transfusion of blood products (type and number of units given)
time frame: From delivery until transfer from Labour Ward, within an expected average of 6 hours.
description: Number of units of blood transfused, or volume of own blood returned to patient if intraoperative cell salvage used
measure: Manual removal of placenta in theatre
time frame: From delivery until transfer from Labour Ward
description: The requirement for the placenta to be removed in theatre
measure: Requirement for surgical intervention to manage PPH
time frame: From delivery until transfer from Labour Ward, within an expected average of 2 days
description: As a result of significant PPH a surgical intervention was required to manage the PPH
measure: Maternal hypertension
time frame: First two postnatal hours following administration of study drug
description: Hypertension
measure: Maternal hypotension
time frame: In first two postnatal hours
description: BP <90/60
measure: Maternally-reported health-related quality of life
time frame: 24 hours after delivery and 14 days after delivery
description: health-related quality of life reported by mother
measure: Abdominal pain in the first two postnatal hours, recorded in Case Report Form (CRF) by midwife
time frame: First 2 post natal hours
description: Patient reported secondary outcome
measure: Post-partum vomiting
time frame: First 2 post natal hours
description: Patient reported secondary outcome
measure: Need for anti-emetic
time frame: First 2 post natal hours
description: Patient reported secondary outcome
By definition, labour starts when the patient is at least 3-4cm dilated with regular, painful contractions.
measure: Headache
time frame: First two post natal hours
description: Patient reported secondary outcome
measure: Maternal experience of side effects
time frame: In first two post natal hours
description: Captured using maternal side effects questionnaire
arm group label: Carbetocin
arm group type: Experimental
description: One dose of 100 micrograms intramuscular Carbetocin given for active management of the third stage of labour, immediately after the birth of the baby
arm group label: Syntocinon
arm group type: Active Comparator
description: One dose of 10 International Units intramuscular Syntocinon given for active management of the third stage of labour, immediately after the birth of the baby
arm group label: Syntometrine
arm group type: Active Comparator
description: One dose of 500micrograms/5 International Units intramuscular Syntometrine given for active management of the third stage of labour, immediately after the birth of the baby
intervention type: Drug
intervention name: Carbetocin
description: The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Carbetocin, listed here, is one of the of the three study drugs.
arm group label: Carbetocin
other name: Pabal
intervention type: Drug
intervention name: Syntocinon
description: The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntocinon, listed here, is one of the of the three study drugs.
arm group label: Syntocinon
other name: Oxytocin
intervention type: Drug
intervention name: Syntometrine
description: The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntometrine, listed here, is one of the of the three study drugs.
arm group label: Syntometrine
other name: Syntometrine 500 micrograms/5 IU Solution for Injection
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tim Draycott, BMBS
role: Study Director
affiliation: North Bristol NHS Trust/University of Bristol
last name: Helen van der Nelson, BMBS
role: Study Chair
affiliation: North Bristol NHS Trust/University of Bristol
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Oxytocin
mesh term: Carbetocin
mesh term: Syntometrine
mesh term: Ergonovine