Breech Presentation; Before LaborBreechNCT06339164
Breech Delivery Skills. Resident Learning Program
An observational study of Breech Presentation; Before Labor, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. Read more about this study
- Who is it for?
- Ages 24 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Breech Presentation; Before Labor
- What is being tested?
- skills and learning quality in breech delivery
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2024to 30 Jun 2024
- 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 24 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: all residents undergoing lecture for obstetric emergencies
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: Breech Delivery Skills. Formal Lecture vs Digital Learning in Resident Learning Program.
Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks. Mannequin scenario represents the best way of skill evaluation
Read the detailed description
Residents will be recruited for "breech delivery" in two different ways. One group (20) will attend a formal frontal lecture on breech delivery of at least one hour. A second group matched for sex distribution, age, residency year (20) will receive a digital lecture. After one month the two groups will test their abilities on a low fidelity mannequin. The simulation session will be recorded and evaluated by 5 specialists in a blind way. During the simulation the main topics of breech extraction are recorded. All residents will receive a questionnaire identifying the subject, previous experience bedside or in a course, and the agreement for video recording and data analysis. After the simulation test they will receive a second questionnaire indicating improvement levels (using a Kirkpatrick model and a 5-point Likert scale).
- Conditions
- Breech Presentation; Before Labor
- Being tested
- skills and learning quality in breech delivery
- Keywords
- breech, learning, mannequin
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skills and learning quality in breech deliveryOther
evaluation of different skill retention and learning quality after different learning methods
| Study group | Role | What they receive |
|---|---|---|
| Formal lecture | residents undergoing frontal lecture one month before the scenario Receives: Other: skills and learning quality in breech delivery | |
| Digital learning | residents learning digitally the topic for at least one month before the scenario Receives: Other: skills and learning quality in breech delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skills capacities
Skills at the scenario (maneuvers). Deriving form charts recorded during the scenario and time enalpsed
Measured: 1 months
Skills capacities
Skills at the scenario evaluated for 5 supervisors
Measured: 1 month
Secondary outcomes (1)
learning qualities
from questionnaire
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 posted1 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech Presentation; Before LaborStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Celentano, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339164
- Sponsor's protocol ID
- ObGynEASC006
- Acronym
- Breech
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: questionnaire on Goggle forms
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breech Delivery Skills. Formal Lecture vs Digital Learning in Resident Learning Program.
- ClinicalTrials.gov ID
- NCT06339164
- Acronym / sponsor ID
- Breech / ObGynEASC006
- Conditions
- Breech Presentation; Before Labor
- Keywords
- breech, learning, mannequin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 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.
Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks. Mannequin scenario represents the best way of skill evaluation
Detailed description
Residents will be recruited for "breech delivery" in two different ways. One group (20) will attend a formal frontal lecture on breech delivery of at least one hour. A second group matched for sex distribution, age, residency year (20) will receive a digital lecture. After one month the two groups will test their abilities on a low fidelity mannequin. The simulation session will be recorded and evaluated by 5 specialists in a blind way. During the simulation the main topics of breech extraction are recorded. All residents will receive a questionnaire identifying the subject, previous experience bedside or in a course, and the agreement for video recording and data analysis. After the simulation test they will receive a second questionnaire indicating improvement levels (using a Kirkpatrick model and a 5-point Likert scale).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formal lecture | – | Other: skills and learning quality in breech deliveryresidents undergoing frontal lecture one month before the scenario |
| Digital learning | – | Other: skills and learning quality in breech deliveryresidents learning digitally the topic for at least one month before the scenario |
Who may qualify
- Ages
- 24 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all residents undergoing lecture for obstetric emergencies
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 |
|---|---|---|
| skills and learning quality in breech deliveryevaluation of different skill retention and learning quality after different learning methods | Other | Digital learning, Formal lecture |
Primary outcome
Skills capacities
Time frame: 1 months
Skills at the scenario (maneuvers). Deriving form charts recorded during the scenario and time enalpsed
Skills capacities
Time frame: 1 month
Skills at the scenario evaluated for 5 supervisors
1 secondary outcome
learning qualities
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 1 Apr 2024.
- Individual participant dataSharing planned: No. questionnaire on Goggle forms
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Breech Presentation
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.
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 Breech Presentation; Before Labor, 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: status not confirmed, as of the sponsor's last update on 1 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 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?
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?
Skills capacities (time frame: 1 months). 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 1 Apr 2024.