- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06358768
Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations (PPH)
April 12, 2024 updated by: Claudio Celentano, G. d'Annunzio University
Post-Partum Hemorrhage and Improvement in Technical Skills on Different Rules Using Actors Scenario
Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Obstetricians, midwives, anesthesiologists, surgical theatre nurses, and sanitary collaborators are enrolled voluntary in a teamwork (2 gynecologists, 2 midwives, 1 anesthesiologist, 1 surgical theatre nurse, and 1 sanitary collaborator) for managing a PPH scenario.
2 different teamworks will attend a frontal lecture of 30' and afterwards they attend a scenario with actors/facilitators (enrolled within ObGyn residents) or attend a scenario with a high-fidelity mannequin after a questionnaire indicating previous experiences and skills (at the end they accept video recording of the scenario and the use of data for scientific reasons).
The teamwork is recorded and an extensive debriefing is conducted using the video records and a dataset indicating positive and negative approach.
After they will answer a questionnaire indicating the use of this scenario and indicating how it is compared to reality.
Personal approach to teamwork job is also described.
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Claudio Celentano, MD
- Phone Number: +39 3285577305
- Email: celentanoclaudio70@gmail.com
Study Locations
-
-
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Bergamo, Italy
- Ospedale Giovanni XXIII
-
Contact:
- Luisa Patanè, MD
- Phone Number: +39 349 3503920
- Email: luisapatane@me.com
-
-
PE
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Pescara, PE, Italy, 65100
- Claudio Celentano
-
Contact:
- Claudio Celentano, MD
- Phone Number: +393285577305
- Email: celentanoclaudio70@gmail.com
-
-
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
N/A
Sampling Method
Probability Sample
Study Population
persons working in our hospitals
Description
Inclusion Criteria:
- personnel working in labour ward and surgical theatre
- Volunteers
Exclusion Criteria:
- none
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gynecologists
ObGyn specialists
|
increase of teamwork capacities and skills improvement
Other Names:
increase of teamwork capacities and skills improvement.
Comparison within different roles and different scenario learning
|
Midwives
Midwives registered
|
increase of teamwork capacities and skills improvement
Other Names:
increase of teamwork capacities and skills improvement.
Comparison within different roles and different scenario learning
|
Anesthesiologists
Anesthesiologists specialists
|
increase of teamwork capacities and skills improvement
Other Names:
increase of teamwork capacities and skills improvement.
Comparison within different roles and different scenario learning
|
Surgical theatre nurse
nurse
|
increase of teamwork capacities and skills improvement
Other Names:
increase of teamwork capacities and skills improvement.
Comparison within different roles and different scenario learning
|
Sanitary support personnel
SSP regularly working in labour ward
|
increase of teamwork capacities and skills improvement
Other Names:
increase of teamwork capacities and skills improvement.
Comparison within different roles and different scenario learning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
teamwork
Time Frame: 1 month
|
Scoring the teamwork efficacy (1-10)
|
1 month
|
skills
Time Frame: 1 month
|
improvement score (1-10)
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
scenario quality
Time Frame: 1 month
|
is the scenario adherent to reality with a score(1-5)
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Claudio Celentano, MD, University d'annunzio
- Principal Investigator: Luisa Patanè, MD, Ospedale Giovanni XXIII Bergamo
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)
May 1, 2024
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
March 17, 2024
First Submitted That Met QC Criteria
April 6, 2024
First Posted (Actual)
April 11, 2024
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ObGynEASC005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
not jet decided
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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