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

Shoulder Dystocia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618565
• Other study ID #: SD-1
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2022
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed consent

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Dystocia
• Shoulder Dystocia

Intervention

Procedure:
• Hands-On Training
one-time, 30 minute hands-on training
• Demonstration
30 minutes passive training

Locations

Country	Name	City	State
Germany	Dept. OBGYN Ruhr University Bochum	Herne
Germany	Dept. OBGYN, Ruhr University Bochum	Herne

Sponsors (1)

Lead Sponsor	Collaborator
Clemens Tempfer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Buerkle B, Pueth J, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective structured assessment of technical skills evaluation of theoretical compared with hands-on training of shoulder dystocia management: a randomized controlled trial. Obstet Gynecol. 2012 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSATS Score	Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.	30 minutes
Secondary	Performance Time	Time probands need to perform all test tasks	30 minutes
Secondary	Global Rating Scale	Predefined score including confidence, speed, and manual capacity to perform test tasks	30 minutes