Shoulder Dystocia - DeliveredNCT05921045
Learning Skills in Shoulder Dystocia Delivery Using Simulator Models
An observational study of Shoulder Dystocia - Delivered and Birth Disorder, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
Learning skills on shoulder dystocia on doctor and midwife Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dystocia - Delivered, Birth Disorder
- What is being tested?
- modification of clinical approach in clinical practice at time 0 and modification of clinical approach in clinical practice at 6 months
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: residents specialists midwies
Who may be able to join
- residents and specialists in obstetrics and gynecology
- midwives
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shoulder Dystocia Delivery and Learning Skills on Mannequin
Learning skills on shoulder dystocia on doctor and midwife
Read the detailed description
Active learning on mannequin for shoulder dystocia deliveries on doctor and midwife using role play approach and its effect on clinical practice using questionnaires after first training and 6 months training
- Conditions
- Shoulder Dystocia - Delivered, Birth Disorder
- Being tested
- modification of clinical approach in clinical practice at time 0, modification of clinical approach in clinical practice at 6 months
- Keywords
- emergency delivery, Shoulder dystocia, mannequin
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modification of clinical approach in clinical practice at time 0Other
Also called questionnaire for evaluation of modification in clinical approach
evaluation of modification in clinical approach after training
modification of clinical approach in clinical practice at 6 monthsOther
Also called questionnaire for evaluation of modification in clinical approach
evaluation of modification in clinical approach after retraining
| Study group | Role | What they receive |
|---|---|---|
| time 0 and 6 months answers | questionnaire answers after first training and after re-training on shoulder dystocia model Receives: Other: modification of clinical approach in clinical practice at time 0; Other: modification of clinical approach in clinical practice at 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of SD
incidence of personal management of SD and fetal and neonatal outcomes in previous experiences and in successive
Measured: 6 months
Secondary outcomes (2)
Clinical approach in labor ward in identification and management of SD (with previous SD)
modification in approach if previous experience occurred
Measured: 6 months
Clinical approach in labor ward in identification and management of SD (without previous SD)
modification in approach without previous experience
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jan 2023
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Dystocia - DeliveredStudies 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
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Hospital, Italy, Federico Prefumo, Istituto Giannina Gaslini, Claudio Meloni, University of Florence
- Responsible party
- Principal investigator, Claudio Celentano, G. d'Annunzio University
- Investigators
- Claudio Celentano, MD, Principal investigator, EASC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921045
- Sponsor's protocol ID
- ObGynEASC002
- Status last verified
- Jul 2023
- First submitted
- 8 Jun 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: recruiting residents, specialists and midwives in University of Chieti and Pescara Hospital
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Dystocia Delivery and Learning Skills on Mannequin
- ClinicalTrials.gov ID
- NCT05921045
- Acronym / sponsor ID
- ObGynEASC002
- Conditions
- Shoulder Dystocia - Delivered, Birth Disorder
- Keywords
- emergency delivery, Shoulder dystocia, mannequin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- Humanitas Hospital, Italy, Federico Prefumo, Istituto Giannina Gaslini, Claudio Meloni, University of Florence
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Jun 2023 (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.
Learning skills on shoulder dystocia on doctor and midwife
Detailed description
Active learning on mannequin for shoulder dystocia deliveries on doctor and midwife using role play approach and its effect on clinical practice using questionnaires after first training and 6 months training
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| time 0 and 6 months answers | – | Other: modification of clinical approach in clinical practice at time 0, Other: modification of clinical approach in clinical practice at 6 monthsquestionnaire answers after first training and after re-training on shoulder dystocia model |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- residents specialists midwies
Key inclusion criteria (2 listed)
- residents and specialists in obstetrics and gynecology
- midwives
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 |
|---|---|---|
| modification of clinical approach in clinical practice at time 0Also: questionnaire for evaluation of modification in clinical approachevaluation of modification in clinical approach after training | Other | time 0 and 6 months answers |
| modification of clinical approach in clinical practice at 6 monthsAlso: questionnaire for evaluation of modification in clinical approachevaluation of modification in clinical approach after retraining | Other | time 0 and 6 months answers |
Primary outcome
Management of SD
Time frame: 6 months
incidence of personal management of SD and fetal and neonatal outcomes in previous experiences and in successive
2 secondary outcomes
Clinical approach in labor ward in identification and management of SD (with previous SD)
Time frame: 6 months
Clinical approach in labor ward in identification and management of SD (without previous SD)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided. recruiting residents, specialists and midwives in University of Chieti and Pescara Hospital
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 principal investigator
EASC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Dystocia - Delivered and Birth Disorder, run by G. d'Annunzio University at 1 site 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: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management of SD (time frame: 6 months). 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 1 Feb 2024.