A Phase 3 interventional study of Hands-On Training and Demonstration in Shoulder Dystocia, sponsored by Clemens Tempfer. Completed at 2 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by Clemens Tempfer · Phase 3, Interventional, and Other
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.
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.
Exclusion Criteria:
30 minutes hands-on training of maneuvers to manage shoulder dystocia
Procedure: Hands-On Training
30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia
Procedure: Demonstration
one-time, 30 minute hands-on training
30 minutes passive training
OSATS Score
Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.
Time frame: 30 minutes
Performance Time
Time probands need to perform all test tasks
Time frame: 30 minutes
Global Rating Scale
Predefined score including confidence, speed, and manual capacity to perform test tasks
Time frame: 30 minutes
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Clemens Tempfer