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CompletedNCT05921045Updated Feb 1, 2024

Learning Skills in Shoulder Dystocia Delivery Using Simulator Models

An observational study in Shoulder Dystocia - Delivered and Birth Disorder, sponsored by G. d'Annunzio University. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by G. d'Annunzio University · Observational

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Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study summary

Learning skills on shoulder dystocia on doctor and midwife

Read the detailed description

Active learning on mannequin for shoulder dystocia deliveries on doctor and midwife using role play approach and its effect on clinical practice using questionnaires after first training and 6 months training

02

Conditions studied

  • Shoulder Dystocia - Delivered
  • Birth Disorder

Keywords

  • emergency delivery
  • Shoulder dystocia
  • mannequin
03

In context

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

110 studies on the registry are indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 20 are open to participants now.

This study's enrollment of 100 is above the median of 75 across 74 observational studies indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities.

Browse Congenital, Hereditary, and Neonatal Diseases and Abnormalities studies →

Lead sponsor

G. d'Annunzio University is the lead sponsor of 68 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
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

residents specialists midwies

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • residents and specialists in obstetrics and gynecology
  • midwives

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • time 0 and 6 months answers

    questionnaire answers after first training and after re-training on shoulder dystocia model

    Other: modification of clinical approach in clinical practice at time 0 · Other: modification of clinical approach in clinical practice at 6 months

Interventions

  • Othermodification of clinical approach in clinical practice at time 0

    evaluation of modification in clinical approach after training

    Also known as: questionnaire for evaluation of modification in clinical approach

  • Othermodification of clinical approach in clinical practice at 6 months

    evaluation of modification in clinical approach after retraining

    Also known as: questionnaire for evaluation of modification in clinical approach

06

What researchers measure

Primary outcomes

  1. Management of SD

    incidence of personal management of SD and fetal and neonatal outcomes in previous experiences and in successive

    Time frame: 6 months

Secondary outcomes

  1. Clinical approach in labor ward in identification and management of SD (with previous SD)

    modification in approach if previous experience occurred

    Time frame: 6 months

  2. Clinical approach in labor ward in identification and management of SD (without previous SD)

    modification in approach without previous experience

    Time frame: 6 months

07

Study locations

1 site
  • Claudio Celentano
    Pescara, Italia 65100, Italy
08

References and documents

Individual participant data

Plan to share: Undecided — recruiting residents, specialists and midwives in University of Chieti and Pescara Hospital

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Dec 2023, 11 months.

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

Registered
Jun 8, 2023
First posted
Jun 27, 2023
StartActual
Jan 1, 2023
Primary completionActual
Dec 30, 2023
CompletionActual
Dec 31, 2023
Last update
Feb 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 Feb 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
NCT05921045
Lead sponsor
G. d'Annunzio University
Collaborators
Claudio Crescini, MD Humanitas Milan Italy, Federico Prefumo, Istituto Giannina Gaslini, Claudio Meloni, University of Florence
Responsible party
Claudio Celentano (Principal investigator, G. d'Annunzio University) — Principal investigator
First posted
Jun 27, 2023
Start date
Jan 1, 2023
Primary completion
Dec 30, 2023
Completion
Dec 31, 2023
Last update
Feb 1, 2024

Study contacts

Claudio Celentano, MD
principal investigator · EASC

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 completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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