PPH - Postpartum HemorrhagePPHNCT06358768
Post-Partum Haemorrhage (PPH) Improvement of Skills With Actor Simulations
An observational study of PPH - Postpartum Hemorrhage, run by G. d'Annunzio University at 2 sites in Italy.
Trial summary
Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- PPH - Postpartum Hemorrhage
- What is being tested?
- teamwork job improvement overall and teamwork job improvement in actor scenario vs mannequin scenario
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 1 May 2024to 30 Sep 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Adult, Older adult
Study population: persons working in our hospitals
Who may be able to join
- personnel working in labour ward and surgical theatre
- Volunteers
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Ospedale Giovanni XXIII
Bergamo
Luisa Patanè, MD, 349 3503920 ext. +39, luisapatane@me.com
Claudio Celentano
Pescara, PE, 65100
Claudio Celentano, MD, +393285577305, celentanoclaudio70@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- PPH - Postpartum Hemorrhage
- Being tested
- teamwork job improvement overall, teamwork job improvement in actor scenario vs mannequin scenario
- Keywords
- PPH, actor scenario, improve skills, improve teamwork reactions
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teamwork job improvement overallOther
Also called skills improvement
increase of teamwork capacities and skills improvement
teamwork job improvement in actor scenario vs mannequin scenarioOther
increase of teamwork capacities and skills improvement. Comparison within different roles and different scenario learning
| Study group | Role | What they receive |
|---|---|---|
| Gynecologists | ObGyn specialists Receives: Other: teamwork job improvement overall; Other: teamwork job improvement in actor scenario vs mannequin scenario | |
| Midwives | Midwives registered Receives: Other: teamwork job improvement overall; Other: teamwork job improvement in actor scenario vs mannequin scenario | |
| Anesthesiologists | Anesthesiologists specialists Receives: Other: teamwork job improvement overall; Other: teamwork job improvement in actor scenario vs mannequin scenario | |
| Surgical theatre nurse | nurse Receives: Other: teamwork job improvement overall; Other: teamwork job improvement in actor scenario vs mannequin scenario | |
| Sanitary support personnel | SSP regularly working in labour ward Receives: Other: teamwork job improvement overall; Other: teamwork job improvement in actor scenario vs mannequin scenario |
What is being measured
The primary outcome is the main question the study is designed to answer.
teamwork
Scoring the teamwork efficacy (1-10)
Measured: 1 month
skills
improvement score (1-10)
Measured: 1 month
Secondary outcomes (1)
scenario quality
is the scenario adherent to reality with a score(1-5)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPH - Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Responsible party
- Principal investigator, Claudio Celentano, G. d'Annunzio University
- Investigators
- Claudio Celentano, MD, Study chair, University d'annunzioLuisa Patanè, MD, Principal investigator, Ospedale Giovanni XXIII Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358768
- Sponsor's protocol ID
- ObGynEASC005
- Acronym
- PPH
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not jet decided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Partum Hemorrhage and Improvement in Technical Skills on Different Rules Using Actors Scenario
- ClinicalTrials.gov ID
- NCT06358768
- Acronym / sponsor ID
- PPH / ObGynEASC005
- Conditions
- PPH - Postpartum Hemorrhage
- Keywords
- PPH, actor scenario, improve skills, improve teamwork reactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gynecologists | – | Other: teamwork job improvement overall, Other: teamwork job improvement in actor scenario vs mannequin scenarioObGyn specialists |
| Midwives | – | Other: teamwork job improvement overall, Other: teamwork job improvement in actor scenario vs mannequin scenarioMidwives registered |
| Anesthesiologists | – | Other: teamwork job improvement overall, Other: teamwork job improvement in actor scenario vs mannequin scenarioAnesthesiologists specialists |
| Surgical theatre nurse | – | Other: teamwork job improvement overall, Other: teamwork job improvement in actor scenario vs mannequin scenarionurse |
| Sanitary support personnel | – | Other: teamwork job improvement overall, Other: teamwork job improvement in actor scenario vs mannequin scenarioSSP regularly working in labour ward |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- persons working in our hospitals
Key inclusion criteria (2 listed)
- personnel working in labour ward and surgical theatre
- Volunteers
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teamwork job improvement overallAlso: skills improvementincrease of teamwork capacities and skills improvement | Other | Anesthesiologists, Gynecologists, Midwives, Sanitary support personnel, Surgical theatre nurse |
| teamwork job improvement in actor scenario vs mannequin scenarioincrease of teamwork capacities and skills improvement. Comparison within different roles and different scenario learning | Other | Anesthesiologists, Gynecologists, Midwives, Sanitary support personnel, Surgical theatre nurse |
Primary outcome
teamwork
Time frame: 1 month
Scoring the teamwork efficacy (1-10)
skills
Time frame: 1 month
improvement score (1-10)
1 secondary outcome
scenario quality
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No. not jet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Celentano, MD study chair
University d'annunzio
Luisa Patanè, MD principal investigator
Ospedale Giovanni XXIII Bergamo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PPH - Postpartum Hemorrhage, run by G. d'Annunzio University at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio Celentano, MD (+39 3285577305, celentanoclaudio70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
teamwork (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.