Twin Vaginal Delivery SkillstwinNCT06127706
Recognition of Second Twin. Second Training vs Naive Performer. PROMPT Mannequin
A study testing twin vaginal delivery simulation in people with Twin Vaginal Delivery Skills, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
Anterior foot identification in second twin delivery Two different population of resident in ObGyn Group 1 previous formal lecture on twin vaginal delivery followed by PROMPT mannequin scenario. Group 2 naive residents Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Twin Vaginal Delivery Skills
- What is being tested?
- twin vaginal delivery simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 15 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- residents in Ob Gyn
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Second Training vs Naive Performer on Second Twin Delivery on Mannequin
Anterior foot identification in second twin delivery Two different population of resident in ObGyn Group 1 previous formal lecture on twin vaginal delivery followed by PROMPT mannequin scenario.
Group 2 naive residents
Read the detailed description
The present study is addressed to evidential skills in residents with and without previous specific didactical approach to twin vaginal delivery in identification of anterior fetal foot.
The two group are randomized by age, sex, seniority. Both the naive and the previous lecture groups are invited to scenario without knowing the intention to test their skills.
The time to reach, the number of attempts are recorded.
- Conditions
- Twin Vaginal Delivery Skills
- Being tested
- twin vaginal delivery simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
twin vaginal delivery simulationDevice
Also called formal lecture, digital learning
skill test after formal lecture and simulation in group 1 and after digital learning only
| Study group | Role | What they receive |
|---|---|---|
| Formal lecture and training | Active comparator | exposure to single test of skills Receives: Device: twin vaginal delivery simulation |
| Digital learning only | Active comparator | exposure to single test of skill Receives: Device: twin vaginal delivery simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to identify foot
time needed to identify foot
Measured: 6 weeks after lecture
number of attempt to identify foot
number of attempt
Measured: 6 weeks after lecture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Oct 2023
- Primary completion30 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Twin Vaginal Delivery SkillsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups randomized One with previous lecture and training, one without
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Celentano, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127706
- Sponsor's protocol ID
- ObGynEASC003
- Acronym
- twin
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data record are available in Cloud to investigators only due to privacy.
Publications
Gauthier S, Jeanneteau P, Legendre G, Boulvais E, Collin R, Malo L, Rolland D, Courtin O, Thubert T, Winer N, Dochez V. Vaginal delivery of the second twin: A simulation program for residents in obstetrics and gynecology in a type III university maternity hospital. J Gynecol Obstet Hum Reprod. 2022 Oct;51(8):102434. doi: 10.1016/j.jogoh.2022.102434. Epub 2022 Jun 26.
PubMed 35768063Desseauve D, Daelemans C, Farin A, Jauvion IBM, Ceccaldi PF; Prise en charge des Accouchements a Risque eT des Urgences Maternelles PARTUM teaching program. Internal podalic version of second twin: Improving feet identification using a simulation model. Eur J Obstet Gynecol Reprod Biol. 2022 Aug;275:9-11. doi: 10.1016/j.ejogrb.2022.05.036. Epub 2022 Jun 6.
PubMed 35691221Celentano C, Prefumo F, Matarrelli B, Mastracchio J, Mauri S, Rosati M. Comparison of practice vs theory model training for vacuum-assisted delivery: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2023 Nov;290:109-114. doi: 10.1016/j.ejogrb.2023.09.024. Epub 2023 Sep 26.
PubMed 37776704
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Training vs Naive Performer on Second Twin Delivery on Mannequin
- ClinicalTrials.gov ID
- NCT06127706
- Acronym / sponsor ID
- twin / ObGynEASC003
- Conditions
- Twin Vaginal Delivery Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 13 Nov 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.
Anterior foot identification in second twin delivery Two different population of resident in ObGyn Group 1 previous formal lecture on twin vaginal delivery followed by PROMPT mannequin scenario.
Group 2 naive residents
Detailed description
The present study is addressed to evidential skills in residents with and without previous specific didactical approach to twin vaginal delivery in identification of anterior fetal foot.
The two group are randomized by age, sex, seniority. Both the naive and the previous lecture groups are invited to scenario without knowing the intention to test their skills.
The time to reach, the number of attempts are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups randomized One with previous lecture and training, one without
| Arm | Type | Receives |
|---|---|---|
| Formal lecture and training | Active comparator | Device: twin vaginal delivery simulationexposure to single test of skills |
| Digital learning only | Active comparator | Device: twin vaginal delivery simulationexposure to single test of skill |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- residents in Ob Gyn
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 |
|---|---|---|
| twin vaginal delivery simulationAlso: formal lecture, digital learningskill test after formal lecture and simulation in group 1 and after digital learning only | Device | Digital learning only, Formal lecture and training |
Primary outcome
time to identify foot
Time frame: 6 weeks after lecture
time needed to identify foot
number of attempt to identify foot
Time frame: 6 weeks after lecture
number of attempt
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 9 Jan 2024.
- Background: PubMed 35768063Gauthier S, Jeanneteau P, Legendre G, Boulvais E, Collin R, Malo L, Rolland D, Courtin O, Thubert T, Winer N, Dochez V. Vaginal delivery of the second twin: A simulation program for residents in obstetrics and gynecology in a type III university maternity hospital. J Gynecol Obstet Hum Reprod. 2022 Oct;51(8):102434. doi: 10.1016/j.jogoh.2022.102434. Epub 2022 Jun 26.
- Background: PubMed 35691221Desseauve D, Daelemans C, Farin A, Jauvion IBM, Ceccaldi PF; Prise en charge des Accouchements a Risque eT des Urgences Maternelles PARTUM teaching program. Internal podalic version of second twin: Improving feet identification using a simulation model. Eur J Obstet Gynecol Reprod Biol. 2022 Aug;275:9-11. doi: 10.1016/j.ejogrb.2022.05.036. Epub 2022 Jun 6.
- Background: PubMed 37776704Celentano C, Prefumo F, Matarrelli B, Mastracchio J, Mauri S, Rosati M. Comparison of practice vs theory model training for vacuum-assisted delivery: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2023 Nov;290:109-114. doi: 10.1016/j.ejogrb.2023.09.024. Epub 2023 Sep 26.
- Individual participant dataSharing planned: No. All data record are available in Cloud to investigators only due to privacy.
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?
A study testing twin vaginal delivery simulation in people with Twin Vaginal Delivery Skills, 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 1 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 9 Jan 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?
time to identify foot (time frame: 6 weeks after lecture). 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?
On the ClinicalTrials.gov record for NCT06127706, which also lists 3 linked publications.
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 9 Jan 2024.