Learning Curves of Different Devices for Vaginal Birth on Mannequin

NCT ID: NCT06923319

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-07-30

Brief Summary

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Learning curves for residents and specialists for devices applied on operative vaginal birth on mannequin (Odòn, Kiwi, Simpson forceps)

Detailed Description

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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

Conditions

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Forceps Delivery Affecting Fetus or Newborn Ventouse Extraction;Liveborn Birth; Forced

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Odòn device

learning time 0, 1 month and 2 month

Odòn, Kiwi, Simpson skills

Intervention Type DEVICE

time 0, time 1 month and 2 months

Kiwi vacuum

learning time 0, 1 month and 2 month

Odòn, Kiwi, Simpson skills

Intervention Type DEVICE

time 0, time 1 month and 2 months

Simpsong forceps

learning time 0, 1 month and 2 month

Odòn, Kiwi, Simpson skills

Intervention Type DEVICE

time 0, time 1 month and 2 months

Interventions

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Odòn, Kiwi, Simpson skills

time 0, time 1 month and 2 months

Intervention Type DEVICE

Other Intervention Names

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retaining of skills

Eligibility Criteria

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Inclusion Criteria

* residents
* specialists

Exclusion Criteria

* none
Minimum Eligible Age

24 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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Claudio Celentano

Head of Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Chieti

Chieti, CH, Italy

Site Status

Santo Spirito Hospital

Pescara, PE, Italy

Site Status

Countries

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Italy

Other Identifiers

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ObGynEASC008

Identifier Type: -

Identifier Source: org_study_id

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