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

Clemens Tempfer

Status and phase: Completed; Phase 3

Conditions: Shoulder Dystocia

Treatments: Procedure: Hands-On Training; Procedure: Demonstration

Study type: Interventional

Funder types: Other

Identifiers

NCT01618565

SD-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• informed consent

Exclusion criteria

• none

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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203 participants in 2 patient groups

Hands-On Training

Experimental group

Description:

30 minutes hands-on training of maneuvers to manage shoulder dystocia

Treatment:

Procedure: Hands-On Training

Demonstration

Active Comparator group

Description:

30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia

Treatment:

Procedure: Demonstration