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

Phase 3

Completed

• Conditions: Shoulder Dystocia

• Registration Number: NCT01618565
• Lead Sponsor: Clemens Tempfer

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• informed consent

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
OSATS Score	30 minutes	Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.

Secondary Outcome Measures

Name	Time	Method
Performance Time	30 minutes	Time probands need to perform all test tasks
Global Rating Scale	30 minutes	Predefined score including confidence, speed, and manual capacity to perform test tasks

Trial Locations

Locations (2)

Dept. OBGYN Ruhr University Bochum; 🇩🇪 Herne, Germany

Dept. OBGYN, Ruhr University Bochum; 🇩🇪 Herne, Germany