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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01618565
First received: June 11, 2012
Last updated: March 8, 2013
Last verified: March 2013
  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

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • informed consent

Exclusion Criteria:

  • none
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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 August 28, 2014