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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

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
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

In context

Breech Presentation

41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.

This study's planned enrollment of 20 is below the median of 135 across 10 observational studies indexed under Breech Presentation.

Browse Breech Presentation studies →

Lead sponsor

G. d'Annunzio University is the lead sponsor of 67 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

-

05

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

06

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — questionnaire on Goggle forms

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2024; primary completion for May 2024, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2024
First posted
Apr 1, 2024
StartEst.
Apr 15, 2024
Primary completionEst.
May 15, 2024
CompletionEst.
Jun 30, 2024
Last update
Apr 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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