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

August 9, 2023 updated by: Cikwanine Buhendwa Jean Paul, Université Evangélique enAfrique

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score obtained before training and immediatly after training
Time Frame: Before and immediatly after training
Difference of mean score obtained before training, immediatly after training using validate qestionnaire
Before and immediatly after training
Score obtained before training and 3 months after training
Time Frame: 3 months after training
Difference of mean score obtained before training and 3 months after training using validated questionnaire
3 months after training
Score obtained before training and 6 months after training
Time Frame: 6 months after training
Difference of mean score obtained before training and 6 months after training using validated questionnaire
6 months after training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSCE (Objective Structural Clinical Exam) Score
Time Frame: Immediatly and 6 months after training
Difference of OSCE mean score obtained before training and 6 months
Immediatly and 6 months after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Evangélique enAfrique

Collaborators

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

July 29, 2023

First Submitted That Met QC Criteria

July 29, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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