Learning Curves of Different Devices for Vaginal Birth on Mannequin

April 3, 2025 updated by: Claudio Celentano, G. d'Annunzio University

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)

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CH
      • Chieti, CH, Italy, 66100
        • University of Chieti
    • PE
      • Pescara, PE, Italy, 65121
        • Santo Spirito Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

ObGyn specialists and residents involved on Labor ward in Pescara Hospital (above 2000 deliveries per year)

Description

Inclusion Criteria:

  • residents
  • specialists

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Odòn device
learning time 0, 1 month and 2 month
Device: Odòn, Kiwi, Simpson skills
time 0, time 1 month and 2 months
Other Names:
  • retaining of skills
Kiwi vacuum
learning time 0, 1 month and 2 month
Device: Odòn, Kiwi, Simpson skills
time 0, time 1 month and 2 months
Other Names:
  • retaining of skills
Simpsong forceps
learning time 0, 1 month and 2 month
Device: Odòn, Kiwi, Simpson skills
time 0, time 1 month and 2 months
Other Names:
  • retaining of skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning curve
Time Frame: time 0
rate of success for each device on mannequin
time 0
retaining of skills
Time Frame: time 1 month
rate of success for each device on mannequin
time 1 month
retaining of skills
Time Frame: time 2 months
rate of success for each device on mannequin
time 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physician approach
Time Frame: time 0, 1 onth and 2 months
subjective approach to the device
time 0, 1 onth and 2 months
residency and year of specialist approach
Time Frame: time 0, 1 month, and 2 months
previous experience and clinical status of trainers
time 0, 1 month, and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G. d'Annunzio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ObGynEASC008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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