- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06127706
Recognition of Second Twin. Second Training vs Naive Performer. PROMPT Mannequin (twin)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Italia
-
Pescara, Italia, Italy, 65100
- Claudio Celentano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- residents in Ob Gyn
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Formal lecture and training
exposure to single test of skills
|
skill test after formal lecture and simulation in group 1 and after digital learning only
Other Names:
|
Active Comparator: Digital learning only
exposure to single test of skill
|
skill test after formal lecture and simulation in group 1 and after digital learning only
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to identify foot
Time Frame: 6 weeks after lecture
|
time needed to identify foot
|
6 weeks after lecture
|
number of attempt to identify foot
Time Frame: 6 weeks after lecture
|
number of attempt
|
6 weeks after lecture
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Desseauve 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.
- Celentano 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ObGynEASC003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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