NCT01618565

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Clemens Tempfer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Shoulder Dystocia

Interventions

Type	Name	Description
PROCEDURE	Hands-On Training	one-time, 30 minute hands-on training
PROCEDURE	Demonstration	30 minutes passive training

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-06-13
• Last updated: 2022-07-08

Locations

2 sites across 1 country: Germany