Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Shoulder Dystocia Management
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Shoulder Dystocia |
Procedure: Hands-On Training Procedure: Demonstration |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
| Official Title: | Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial |
- OSATS Score [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Probands are tested with a 22 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 72 hours thereafter.
- Performance Time [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Time probands need to perform all test tasks
- Global Rating Scale [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Predefined score including confidence, speed, and manual capacity to perform test tasks
| Enrollment: | 203 |
| Study Start Date: | April 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hands-On Training
30 minutes hands-on training of maneuvers to manage shoulder dystocia
|
Procedure: Hands-On Training
one-time, 30 minute hands-on training
|
|
Active Comparator: Demonstration
30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia
|
Procedure: Demonstration
30 minutes passive training
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- informed consent
Exclusion Criteria:
- none
Contacts and Locations More Information
No publications provided by Ruhr University of Bochum
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Clemens Tempfer, Department head ObGyn, Ruhr University of Bochum |
| ClinicalTrials.gov Identifier: | NCT01618565 History of Changes |
| Other Study ID Numbers: | SD-1 |
| Study First Received: | June 11, 2012 |
| Last Updated: | March 8, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ruhr University of Bochum:
|
shoulder dystocia training To assess the effectiveness of hands-on training versus expert demonstration |
Additional relevant MeSH terms:
|
Dystocia Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 16, 2013