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Simulation for the Retention of Skills in the Management of Obstetric Hemorrhages (SimHPP)

Primary Purpose

Postpartum Hemorrhage, Simulation Training, Healthcare Providers

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Simulation training
Sponsored by
Université Evangélique enAfrique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postpartum Hemorrhage focused on measuring OSCE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Work in one of the selected maternity units Have two years' experience Be either a gynaecologist, obstetrician, general practitioner, midwife, nurse, anaesthetist or laboratory technician. Exclusion Criteria: -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Theoretical education

    Theoretical education PLUS simulation training

    Arm Description

    Outcomes

    Primary Outcome Measures

    Score obtained before training and immediatly after training
    Difference of mean score obtained before training, immediatly after training using validate qestionnaire
    Score obtained before training and 3 months after training
    Difference of mean score obtained before training and 3 months after training using validated questionnaire
    Score obtained before training and 6 months after training
    Difference of mean score obtained before training and 6 months after training using validated questionnaire

    Secondary Outcome Measures

    OSCE (Objective Structural Clinical Exam) Score
    Difference of OSCE mean score obtained before training and 6 months

    Full Information

    First Posted
    July 29, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Université Evangélique enAfrique
    Collaborators
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05979701
    Brief Title
    Simulation for the Retention of Skills in the Management of Obstetric Hemorrhages
    Acronym
    SimHPP
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2023 (Anticipated)
    Primary Completion Date
    January 15, 2024 (Anticipated)
    Study Completion Date
    May 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université Evangélique enAfrique
    Collaborators
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Hemorrhage, Simulation Training, Healthcare Providers
    Keywords
    OSCE

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Theoretical education
    Arm Type
    No Intervention
    Arm Title
    Theoretical education PLUS simulation training
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Simulation training
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Score obtained before training and immediatly after training
    Description
    Difference of mean score obtained before training, immediatly after training using validate qestionnaire
    Time Frame
    Before and immediatly after training
    Title
    Score obtained before training and 3 months after training
    Description
    Difference of mean score obtained before training and 3 months after training using validated questionnaire
    Time Frame
    3 months after training
    Title
    Score obtained before training and 6 months after training
    Description
    Difference of mean score obtained before training and 6 months after training using validated questionnaire
    Time Frame
    6 months after training
    Secondary Outcome Measure Information:
    Title
    OSCE (Objective Structural Clinical Exam) Score
    Description
    Difference of OSCE mean score obtained before training and 6 months
    Time Frame
    Immediatly and 6 months after training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Work in one of the selected maternity units Have two years' experience Be either a gynaecologist, obstetrician, general practitioner, midwife, nurse, anaesthetist or laboratory technician. Exclusion Criteria: -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Simulation for the Retention of Skills in the Management of Obstetric Hemorrhages

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