xml: <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/NCT05979701</url>
    </required_header>
    <id_info>
      <org_study_id>001</org_study_id>
      <nct_id>NCT05979701</nct_id>
    </id_info>
    <brief_title>Simulation for the Retention of Skills in the Management of Obstetric Hemorrhages</brief_title>
    <acronym>SimHPP</acronym>
    <official_title>Use of Simulation Training Versus Theoretical Learning for the Retention of Knowledge and Skills in the Management of Postpartum Hemorrhage: A Multicenter, Comparative Study in Eastern DRCongo.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Université Evangélique enAfrique</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University Hospital, Angers</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Université Evangélique enAfrique</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to evaluate the retention of knowledge and skills after&#xD;
        theory+simulation training versus theoretical training alone in postpartum haemorrhage&#xD;
        immediately, 3 months and 6 months after training in South Kivu, in the east of the&#xD;
        Democratic Republic of Congo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">May 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 15, 2024</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>
      <intervention_model_description>Randomized controlled trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Score obtained before training and immediatly after training</measure>
      <time_frame>Before and immediatly after training</time_frame>
      <description>Difference of mean score obtained before training, immediatly after training using validate qestionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Score obtained before training and 3 months after training</measure>
      <time_frame>3 months after training</time_frame>
      <description>Difference of mean score obtained before training and 3 months after training using validated questionnaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Score obtained before training and 6 months after training</measure>
      <time_frame>6 months after training</time_frame>
      <description>Difference of mean score obtained before training and 6 months after training using validated questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>OSCE (Objective Structural Clinical Exam) Score</measure>
      <time_frame>Immediatly and 6 months after training</time_frame>
      <description>Difference of OSCE mean score obtained before training and 6 months</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Postpartum Hemorrhage</condition>
    <condition>Simulation Training</condition>
    <condition>Healthcare Providers</condition>
    <arm_group>
      <arm_group_label>Theoretical education</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Theoretical education PLUS simulation training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Simulation training</intervention_name>
      <description>The intervention will consist of training participants through simulation in addition to theoretical training. The simulation will cover 3 themes, including diagnosis of haemorrhage, communication between healthcare providers, management of post-partum haemorrhage and transfusion monitoring.</description>
      <arm_group_label>Theoretical education PLUS simulation training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Work in one of the selected maternity units&#xD;
  &#xD;
            -  Have two years' experience&#xD;
  &#xD;
            -  Be either a gynaecologist, obstetrician, general practitioner, midwife, nurse,&#xD;
               anaesthetist or laboratory technician.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Université Evangélique enAfrique</investigator_affiliation>
      <investigator_full_name>Cikwanine Buhendwa Jean Paul</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>OSCE</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>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979701
  org study id: 001
  nct id: NCT05979701
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the retention of knowledge and skills after
        theory+simulation training versus theoretical training alone in postpartum haemorrhage
        immediately, 3 months and 6 months after training in South Kivu, in the east of the
        Democratic Republic of Congo.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial
  primary purpose: Other
  masking: None (Open Label)
  measure: Score obtained before training and immediatly after training
  time frame: Before and immediatly after training
  description: Difference of mean score obtained before training, immediatly after training using validate qestionnaire
  measure: Score obtained before training and 3 months after training
  time frame: 3 months after training
  description: Difference of mean score obtained before training and 3 months after training using validated questionnaire
  measure: Score obtained before training and 6 months after training
  time frame: 6 months after training
  description: Difference of mean score obtained before training and 6 months after training using validated questionnaire
  measure: OSCE (Objective Structural Clinical Exam) Score
  time frame: Immediatly and 6 months after training
  description: Difference of OSCE mean score obtained before training and 6 months
  arm group label: Theoretical education
  arm group type: No Intervention
  arm group label: Theoretical education PLUS simulation training
  arm group type: Experimental
  intervention type: Other
  intervention name: Simulation training
  description: The intervention will consist of training participants through simulation in addition to theoretical training. The simulation will cover 3 themes, including diagnosis of haemorrhage, communication between healthcare providers, management of post-partum haemorrhage and transfusion monitoring.
  arm group label: Theoretical education PLUS simulation training
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Université Evangélique enAfrique
  investigator full name: Cikwanine Buhendwa Jean Paul
  investigator title: Principal Investigator
  mesh term: Postpartum Hemorrhage
  mesh term: Hemorrhage
  sharing ipd: Undecided