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Not yet recruitingNCT06339164BreechUpdated Apr 1, 2024

Breech Delivery Skills. Resident Learning Program

An observational study in Breech Presentation; Before Labor, sponsored by G. d'Annunzio University. Not yet recruiting at 1 site in Italy. Open to participants aged 24 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-01.

Sponsored by G. d'Annunzio University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
20
Ages
24 Years to 38 Years
Sex
All
01

Study summary

Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks. Mannequin scenario represents the best way of skill evaluation

Read the detailed description

Residents will be recruited for "breech delivery" in two different ways. One group (20) will attend a formal frontal lecture on breech delivery of at least one hour. A second group matched for sex distribution, age, residency year (20) will receive a digital lecture. After one month the two groups will test their abilities on a low fidelity mannequin. The simulation session will be recorded and evaluated by 5 specialists in a blind way. During the simulation the main topics of breech extraction are recorded. All residents will receive a questionnaire identifying the subject, previous experience bedside or in a course, and the agreement for video recording and data analysis. After the simulation test they will receive a second questionnaire indicating improvement levels (using a Kirkpatrick model and a 5-point Likert scale).

02

Conditions studied

  • Breech Presentation; Before Labor

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Keywords

  • breech, learning, mannequin
03

Who can participate

Ages eligible
24 Years to 38 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

all residents undergoing lecture for obstetric emergencies

Eligibility criteria

Inclusion Criteria: residents in University of Chieti Medical school -

Exclusion Criteria: none

-

04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Formal lecture

    residents undergoing frontal lecture one month before the scenario

    Other: skills and learning quality in breech delivery

  • Digital learning

    residents learning digitally the topic for at least one month before the scenario

    Other: skills and learning quality in breech delivery

Interventions

  • Otherskills and learning quality in breech delivery

    evaluation of different skill retention and learning quality after different learning methods

05

What researchers measure

Primary outcomes

  1. Skills capacities

    Skills at the scenario (maneuvers). Deriving form charts recorded during the scenario and time enalpsed

    Time frame: 1 months

  2. Skills capacities

    Skills at the scenario evaluated for 5 supervisors

    Time frame: 1 month

Secondary outcomes

  1. learning qualities

    from questionnaire

    Time frame: 1 month

06

Study locations

1 site
  • Claudio Celentano
    Pescara, PE 65100, Italy
07

References and documents

Individual participant data

Plan to share: No — questionnaire on Goggle forms

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06339164
Lead sponsor
G. d'Annunzio University
Responsible party
Claudio Celentano (MD, G. d'Annunzio University) — Principal investigator
First posted
Apr 1, 2024
Start date
Apr 15, 2024 (estimated)
Primary completion
May 15, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Apr 1, 2024

Study contacts

Claudio Celentano, MD
Contact
celentanoclaudio70@gmail.com
+39 3285577305

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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