Forceps Delivery Affecting Fetus or NewbornNCT06923319
Learning Curves of Different Devices for Vaginal Birth on Mannequin
An observational study of Forceps Delivery Affecting Fetus or Newborn and Ventouse Extraction;Liveborn, run by G. d'Annunzio University at 2 sites in Italy.
Trial summary
Learning curves for residents and specialists for devices applied on operative vaginal birth on mannequin (Odòn, Kiwi, Simpson forceps) Read more about this study
- Who is it for?
- Ages 24 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Forceps Delivery Affecting Fetus or Newborn, Ventouse Extraction;Liveborn, Birth; Forced
- What is being tested?
- Odòn, Kiwi, Simpson skills
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Feb 2025to 30 Jul 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ObGyn specialists and residents involved on Labor ward in Pescara Hospital (above 2000 deliveries per year)
Who may be able to join
- residents
- specialists
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
University of Chieti
Chieti, CH, 66100
Santo Spirito Hospital
Pescara, PE, 65121
About this study
Official title: Learning Curves for Odòn, Kiwi Vacuum, and Simpson Forceps for Vaginal Birth on Mannequin
Learning curves for residents and specialists for devices applied on operative vaginal birth on mannequin (Odòn, Kiwi, Simpson forceps)
Read the detailed description
Residents and specialists were exposed to formal lecture having the opportunity of digital evaluation of digital support. After a frontal lecture they will have a formal explanation of mannequin approach for each device (Odòn, Kiwi, Simpson) After one month and after two month they will re-train on mannequin for each device.
Before frontal lecture they will answer to a questionnaire evaluating status of residency (year), elderly of specialization (years after degree) and personal experience in labor ward and on mannequin for training. After each training session they will have a further questionnaire evaluating how the training was working on their knowledge and on retaining of skills.
All training sessions will be recorded in a blind way erasing voice and face and with a ID computer generated code.
All videos will be evaluated by three different specialists of known experience on the three devices
- Being tested
- Odòn, Kiwi, Simpson skills
- Keywords
- Odòn, Kiwi vacuum, Simpson forceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Odòn, Kiwi, Simpson skillsDevice
Also called retaining of skills
time 0, time 1 month and 2 months
| Study group | Role | What they receive |
|---|---|---|
| Odòn device | learning time 0, 1 month and 2 month Receives: Device: Odòn, Kiwi, Simpson skills | |
| Kiwi vacuum | learning time 0, 1 month and 2 month Receives: Device: Odòn, Kiwi, Simpson skills | |
| Simpsong forceps | learning time 0, 1 month and 2 month Receives: Device: Odòn, Kiwi, Simpson skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning curve
rate of success for each device on mannequin
Measured: time 0
retaining of skills
rate of success for each device on mannequin
Measured: time 1 month
retaining of skills
rate of success for each device on mannequin
Measured: time 2 months
Secondary outcomes (2)
physician approach
subjective approach to the device
Measured: time 0, 1 onth and 2 months
residency and year of specialist approach
previous experience and clinical status of trainers
Measured: time 0, 1 month, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Feb 2025
- Primary completion15 Apr 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forceps Delivery Affecting Fetus or NewbornStudies 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Months
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
- NCT06923319
- Sponsor's protocol ID
- ObGynEASC008
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curves for Odòn, Kiwi Vacuum, and Simpson Forceps for Vaginal Birth on Mannequin
- ClinicalTrials.gov ID
- NCT06923319
- Acronym / sponsor ID
- ObGynEASC008
- Keywords
- Odòn, Kiwi vacuum, Simpson forceps
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 11 Apr 2025 (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 curves for residents and specialists for devices applied on operative vaginal birth on mannequin (Odòn, Kiwi, Simpson forceps)
Detailed description
Residents and specialists were exposed to formal lecture having the opportunity of digital evaluation of digital support. After a frontal lecture they will have a formal explanation of mannequin approach for each device (Odòn, Kiwi, Simpson) After one month and after two month they will re-train on mannequin for each device.
Before frontal lecture they will answer to a questionnaire evaluating status of residency (year), elderly of specialization (years after degree) and personal experience in labor ward and on mannequin for training. After each training session they will have a further questionnaire evaluating how the training was working on their knowledge and on retaining of skills.
All training sessions will be recorded in a blind way erasing voice and face and with a ID computer generated code.
All videos will be evaluated by three different specialists of known experience on the three devices
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Odòn device | – | Device: Odòn, Kiwi, Simpson skillslearning time 0, 1 month and 2 month |
| Kiwi vacuum | – | Device: Odòn, Kiwi, Simpson skillslearning time 0, 1 month and 2 month |
| Simpsong forceps | – | Device: Odòn, Kiwi, Simpson skillslearning time 0, 1 month and 2 month |
Who may qualify
- Ages
- 24 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ObGyn specialists and residents involved on Labor ward in Pescara Hospital (above 2000 deliveries per year)
Key inclusion criteria (2 listed)
- residents
- specialists
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 |
|---|---|---|
| Odòn, Kiwi, Simpson skillsAlso: retaining of skillstime 0, time 1 month and 2 months | Device | Kiwi vacuum, Odòn device, Simpsong forceps |
Primary outcome
Learning curve
Time frame: time 0
rate of success for each device on mannequin
retaining of skills
Time frame: time 1 month
rate of success for each device on mannequin
retaining of skills
Time frame: time 2 months
rate of success for each device on mannequin
2 secondary outcomes
physician approach
Time frame: time 0, 1 onth and 2 months
residency and year of specialist approach
Time frame: time 0, 1 month, and 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Undecided. not decided yet
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Forceps Delivery Affecting Fetus or Newborn and Ventouse Extraction;Liveborn, 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: enrolling by invitation, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Learning curve (time frame: time 0). The study lists 3 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 11 Apr 2025.