<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/NCT02223806</url>
  </required_header>
  <id_info>
    <org_study_id>UMC-GH 002</org_study_id>
    <nct_id>NCT02223806</nct_id>
  </id_info>
  <brief_title>Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration</brief_title>
  <acronym>UTAMP</acronym>
  <official_title>Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korle-Bu Teaching Hospital, Accra, Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether there is a difference in effectiveness of routine uterine tonus&#xD;
      assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered&#xD;
      by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal&#xD;
      and neonatal outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Postpartum haemorrhage (PPH) is the most common cause of maternal death worldwide.&#xD;
      The active management of the third stage of labour (AMTSL) is recognized as an effective&#xD;
      strategy to prevent morbidity and mortality associated with PPH and reduce blood loss. AMTSL&#xD;
      includes the provision of uterotonic drugs, controlled cord traction, delayed cord clamping&#xD;
      and cutting, massage of the uterus, and monitoring of the uterine tonus. Although&#xD;
      professional guidelines recommend the steps of AMTSL to be performed by health professionals,&#xD;
      the reality of health professionals understaffed hospitals in many low- and middle income&#xD;
      countries (LMICs) necessitates task-shifting of the final AMTSL component to patients. Yet,&#xD;
      whether uterine tonus assessment yields the same effect when performed by patients and&#xD;
      midwives has not been formally evaluated.&#xD;
&#xD;
      Objective: To determine whether there is a difference in effectiveness of routine uterine&#xD;
      tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or&#xD;
      self-administered by a patient on the incidence of postpartum haemorrhage . mean blood loss,&#xD;
      and other maternal and neonatal outcomes.&#xD;
&#xD;
      Study design: Randomized intervention study. Study population: Pregnant women admitted in the&#xD;
      labour to the Korle Bu Teaching Hospital, Accra, Ghana Intervention: the intervention group&#xD;
      will receive uterine tonus assessment every 15 minutes for 2 hours by a midwife, the control&#xD;
      group will continue the current practice of self-assessment after patient education with&#xD;
      regular monitoring of midwives.&#xD;
&#xD;
      Main study parameters/endpoints: post-partum haemorrhage (&gt;500 ml blood loss), severe&#xD;
      postpartum haemorrhage (&gt;1000 ml blood loss), mean blood loss, other maternal and neonatal&#xD;
      outcomes.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: Patients will receive the standard of midwifery and obstetric care, and will&#xD;
      have access to emergency obstetric interventions. All steps of the AMTSL will be performed,&#xD;
      with the exemption of the last step of uterine tonus assessment for which women will be&#xD;
      randomized to receive the intervention or current practice of care. Risk associated with the&#xD;
      intervention are discomfort because of an external assessment. Data will be obtained from&#xD;
      record books at the ward. Women will be asked for informed consent prior to participation.&#xD;
      This study will be approved by the Ethical en Protocol Review Committee of the University of&#xD;
      Ghana Medical School and the Medical Ethical Research Committee of the University Medical&#xD;
      Center Utrecht.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postpartum hemorrhage (&gt;500 ml blood loss)</measure>
    <time_frame>within 24 hours postpartum</time_frame>
    <description>To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) to prevent post-partum hemorrhage (≥500 ml blood loss) when performed by a midwife and self-administered by a patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean blood loss (in ml)</measure>
    <time_frame>Within 24 hours postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe post-partum hemorrhage</measure>
    <time_frame>Within 24 hours postpartum</time_frame>
    <description>&gt;1000ml blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of additional uterotonics</measure>
    <time_frame>Within 24 hours postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of other procedures for management of postpartum hemorrhage</measure>
    <time_frame>Within 24 hours postpartum</time_frame>
    <description>I.e. surgery, manual placenta tissue removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late postpartum hemorrhage</measure>
    <time_frame>From 24 hours and upto one week</time_frame>
    <description>Based on readmission</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Self-assessment of uterine tonus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Uterine tonus assessment every 15 minutes for 2 hours by educated patient, which is standard-of-care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midwife uterine tonus assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Uterine tonus assessment every 15 minutes for 2 hours by midwive.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Uterine Tonus Assessment by Midwife</intervention_name>
    <description>Uterine tonus assessment every 15 minutes for 2 hours.</description>
    <arm_group_label>Midwife uterine tonus assessment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient self-assessment of uterine tonus</intervention_name>
    <description>Uterine tonus assessment by patient every 15 minutes for 2 hours.</description>
    <arm_group_label>Self-assessment of uterine tonus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Be in labor with an expected vaginal delivery, as assessed by the midwives&#xD;
&#xD;
          -  Gestation age ≥ 37 weeks&#xD;
&#xD;
          -  Received antenatal instructions on postnatal uterine tonus assessment&#xD;
&#xD;
          -  Provided informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  Elective caesarean delivery&#xD;
&#xD;
          -  Severe anemia (&lt;8g/dL)&#xD;
&#xD;
          -  Placenta praevia&#xD;
&#xD;
          -  Anticipated breech delivery&#xD;
&#xD;
          -  Referred patients who have not received antenatal care (ANC) uterine tonus assessment&#xD;
             instructions&#xD;
&#xD;
          -  Multiple Pregnancy&#xD;
&#xD;
          -  Intra uterine fetal death&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joyce L Browne, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Utrecht, the Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kerstin D Klipstein-Grobusch, PhD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Utrecht, The Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nelson Damale, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korle-Bu Teaching Hospital, Accra, Ghana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korle Bu Teaching Hospital</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>Joyce L. Browne</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Postpartum hemorrhage</keyword>
  <keyword>Uterine tonus assessment</keyword>
  <keyword>Active management of third stage of labor</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>
  <!-- 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/NCT02223806
org study id: UMC-GH 002
nct id: NCT02223806
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
To determine whether there is a difference in effectiveness of routine uterine tonus
      assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered
      by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal
      and neonatal outcomes.
Rationale: Postpartum haemorrhage (PPH) is the most common cause of maternal death worldwide.
      The active management of the third stage of labour (AMTSL) is recognized as an effective
      strategy to prevent morbidity and mortality associated with PPH and reduce blood loss. AMTSL
      includes the provision of uterotonic drugs, controlled cord traction, delayed cord clamping
      and cutting, massage of the uterus, and monitoring of the uterine tonus. Although
      professional guidelines recommend the steps of AMTSL to be performed by health professionals,
      the reality of health professionals understaffed hospitals in many low- and middle income
      countries (LMICs) necessitates task-shifting of the final AMTSL component to patients. Yet,
      whether uterine tonus assessment yields the same effect when performed by patients and
      midwives has not been formally evaluated.

      Objective: To determine whether there is a difference in effectiveness of routine uterine
      tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or
      self-administered by a patient on the incidence of postpartum haemorrhage . mean blood loss,
      and other maternal and neonatal outcomes.

      Study design: Randomized intervention study. Study population: Pregnant women admitted in the
      labour to the Korle Bu Teaching Hospital, Accra, Ghana Intervention: the intervention group
      will receive uterine tonus assessment every 15 minutes for 2 hours by a midwife, the control
      group will continue the current practice of self-assessment after patient education with
      regular monitoring of midwives.

      Main study parameters/endpoints: post-partum haemorrhage (>500 ml blood loss), severe
      postpartum haemorrhage (>1000 ml blood loss), mean blood loss, other maternal and neonatal
      outcomes.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Patients will receive the standard of midwifery and obstetric care, and will
      have access to emergency obstetric interventions. All steps of the AMTSL will be performed,
      with the exemption of the last step of uterine tonus assessment for which women will be
      randomized to receive the intervention or current practice of care. Risk associated with the
      intervention are discomfort because of an external assessment. Data will be obtained from
      record books at the ward. Women will be asked for informed consent prior to participation.
      This study will be approved by the Ethical en Protocol Review Committee of the University of
      Ghana Medical School and the Medical Ethical Research Committee of the University Medical
      Center Utrecht.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Postpartum hemorrhage (>500 ml blood loss)
time frame: within 24 hours postpartum
description: To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) to prevent post-partum hemorrhage (≥500 ml blood loss) when performed by a midwife and self-administered by a patient.
measure: Mean blood loss (in ml)
time frame: Within 24 hours postpartum
measure: Severe post-partum hemorrhage
time frame: Within 24 hours postpartum
description: >1000ml blood loss
measure: Use of additional uterotonics
time frame: Within 24 hours postpartum
measure: Use of other procedures for management of postpartum hemorrhage
time frame: Within 24 hours postpartum
description: I.e. surgery, manual placenta tissue removal
measure: Late postpartum hemorrhage
time frame: From 24 hours and upto one week
description: Based on readmission
arm group label: Self-assessment of uterine tonus
arm group type: Active Comparator
description: Uterine tonus assessment every 15 minutes for 2 hours by educated patient, which is standard-of-care.
arm group label: Midwife uterine tonus assessment
arm group type: Experimental
description: Uterine tonus assessment every 15 minutes for 2 hours by midwive.
intervention type: Behavioral
intervention name: Uterine Tonus Assessment by Midwife
description: Uterine tonus assessment every 15 minutes for 2 hours.
arm group label: Midwife uterine tonus assessment
intervention type: Behavioral
intervention name: Patient self-assessment of uterine tonus
description: Uterine tonus assessment by patient every 15 minutes for 2 hours.
arm group label: Self-assessment of uterine tonus
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joyce L Browne, MD, MSc
role: Principal Investigator
affiliation: UMC Utrecht, the Netherlands
last name: Kerstin D Klipstein-Grobusch, PhD MSc
role: Principal Investigator
affiliation: University Medical Center Utrecht, The Netherlands
last name: Nelson Damale, MBChB
role: Principal Investigator
affiliation: Korle-Bu Teaching Hospital, Accra, Ghana
facility: 
country: Ghana
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: Joyce L. Browne
investigator title: Dr.
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage