Skip to content

Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management

Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01618565
Enrollment
203
Registered
2012-06-13
Start date
2012-04-30
Completion date
2012-12-31
Last updated
2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dystocia

Keywords

shoulder dystocia, training, To assess the effectiveness of hands-on training versus expert demonstration

Brief summary

This trial tests whether hands-on training is superior to expert demonstration regarding the management of shoulder dystocia (stuck shoulder) during delivery on a training model.

Detailed description

We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized SD algorithm scheme on a pelvic training model. Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.

Interventions

one-time, 30 minute hands-on training

PROCEDUREDemonstration

30 minutes passive training

Sponsors

Clemens Tempfer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* informed consent

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
OSATS Score30 minutesProbands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.

Secondary

MeasureTime frameDescription
Performance Time30 minutesTime probands need to perform all test tasks
Global Rating Scale30 minutesPredefined score including confidence, speed, and manual capacity to perform test tasks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026