Birth DisorderNCT05605626
Learning Skills in Young Specialists and Residents in Operative Vaginal Delivery Using Simulator Models
An observational study of Birth Disorder and Delivery Complication, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
Evaluation of different learning programs on persistence of skills in operative vaginal delivery Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Birth Disorder, Delivery Complication
- What is being tested?
- the better retaining of skills
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2021to 1 Apr 2022
- How long will I take part?
- 1 Year
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: participants were residents in ObGyn or young specialists in ObGyn (less than 5 years)
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operative Vaginal Delivery in Residents and Young Specialists
Evaluation of different learning programs on persistence of skills in operative vaginal delivery
Read the detailed description
Investigators enrolled residents and young specialist randomly exposed to simulation of operative vaginal delivery or a lecture before and after experience on simulator program. The two groups were exposed after 8-12 weeks to a second experience of simulator program due to evaluate the improve, deterioration of skills in operative vaginal delivery.
12-months persistence of skills were evaluated
- Conditions
- Birth Disorder, Delivery Complication
- Being tested
- the better retaining of skills
- Keywords
- vaginal birth, vacuum delivery, operative vaginal birth, mannequin training program
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the better retaining of skillsOther
identify which teaching program has the better retaining of skills
| Study group | Role | What they receive |
|---|---|---|
| Simulator training before | group exposed directly to simulator training without knowing the topic of obstetric emergency Receives: Other: the better retaining of skills | |
| lesson before simulation training | group undergoing formal lecture before the vacuum delivery simulation on mannequin Receives: Other: the better retaining of skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
improving and retaining skills in two different groups of teaching programs
evaluate video recorded simulations using items and total value during the operative vaginal delivery on manequin
Measured: 12 weeks and 1 year
Secondary outcomes (1)
improve skills in obstetric emergencies considering year of formation and teaching programs
Comparison of quality scale per items
Measured: 12 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start15 Jun 2021
- Primary completion30 Oct 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth DisorderStudies 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
- 24 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- Santo Spirito Hospital, Italy
- Responsible party
- Principal investigator, Claudio Celentano, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605626
- Sponsor's protocol ID
- ObGynEASC001
- Status last verified
- Oct 2022
- First submitted
- 26 Mar 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Simulation in EASC
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Vaginal Delivery in Residents and Young Specialists
- ClinicalTrials.gov ID
- NCT05605626
- Acronym / sponsor ID
- ObGynEASC001
- Conditions
- Birth Disorder, Delivery Complication
- Keywords
- vaginal birth, vacuum delivery, operative vaginal birth, mannequin training program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- Santo Spirito Hospital, Italy
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 4 Nov 2022 (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.
Evaluation of different learning programs on persistence of skills in operative vaginal delivery
Detailed description
Investigators enrolled residents and young specialist randomly exposed to simulation of operative vaginal delivery or a lecture before and after experience on simulator program. The two groups were exposed after 8-12 weeks to a second experience of simulator program due to evaluate the improve, deterioration of skills in operative vaginal delivery.
12-months persistence of skills were evaluated
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulator training before | – | Other: the better retaining of skillsgroup exposed directly to simulator training without knowing the topic of obstetric emergency |
| lesson before simulation training | – | Other: the better retaining of skillsgroup undergoing formal lecture before the vacuum delivery simulation on mannequin |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- participants were residents in ObGyn or young specialists in ObGyn (less than 5 years)
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| the better retaining of skillsidentify which teaching program has the better retaining of skills | Other | Simulator training before, lesson before simulation training |
Primary outcome
improving and retaining skills in two different groups of teaching programs
Time frame: 12 weeks and 1 year
evaluate video recorded simulations using items and total value during the operative vaginal delivery on manequin
1 secondary outcome
improve skills in obstetric emergencies considering year of formation and teaching programs
Time frame: 12 weeks and 1 year
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 4 Nov 2022.
- Individual participant dataSharing planned: No. Simulation in EASC
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Birth Disorder and Delivery Complication, 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 0 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 4 Nov 2022. 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?
improving and retaining skills in two different groups of teaching programs (time frame: 12 weeks and 1 year). 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 4 Nov 2022.