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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618565
First Posted: June 13, 2012
Last Update Posted: March 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum
  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 (Participant, 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

Further study details as provided by Clemens Tempfer, Ruhr University of Bochum:

Primary Outcome Measures:
  • OSATS Score [ Time Frame: 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:
  • Performance Time [ Time Frame: 30 minutes ]
    Time probands need to perform all test tasks

  • Global Rating Scale [ Time Frame: 30 minutes ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • informed consent

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618565


Locations
Germany
Dept. OBGYN Ruhr University Bochum
Herne, Germany, 44625
Dept. OBGYN, Ruhr University Bochum
Herne, Germany, 44625
Sponsors and Collaborators
Clemens Tempfer
  More Information

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
First Submitted: June 11, 2012
First Posted: June 13, 2012
Last Update Posted: March 11, 2013
Last Verified: March 2013

Keywords provided by Clemens Tempfer, 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