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

Sponsor
Université Evangélique enAfrique (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05979701
Collaborator
University Hospital, Angers (Other)
30
Enrollment
2
Arms
9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Simulation training
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Other
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.
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
May 15, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Theoretical education
Experimental: Theoretical education PLUS simulation training

Other: Simulation training
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.

Outcome Measures

Primary Outcome Measures

  1. Score obtained before training and immediatly after training [Before and immediatly after training]

    Difference of mean score obtained before training, immediatly after training using validate qestionnaire

  2. Score obtained before training and 3 months after training [3 months after training]

    Difference of mean score obtained before training and 3 months after training using validated questionnaire

  3. Score obtained before training and 6 months after training [6 months after training]

    Difference of mean score obtained before training and 6 months after training using validated questionnaire

Secondary Outcome Measures

  1. OSCE (Objective Structural Clinical Exam) Score [Immediatly and 6 months after training]

    Difference of OSCE mean score obtained before training and 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Université Evangélique enAfrique
  • University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cikwanine Buhendwa Jean Paul, Principal Investigator, Université Evangélique enAfrique
ClinicalTrials.gov Identifier:
NCT05979701
Other Study ID Numbers:
  • 001
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cikwanine Buhendwa Jean Paul, Principal Investigator, Université Evangélique enAfrique
OSCE
Additional relevant MeSH terms:
Postpartum Hemorrhage
Hemorrhage

Study Results

No Results Posted as of Aug 14, 2023