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

July 7, 2022 updated by: Clemens Tempfer

Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Theoretical Versus Hands-On Training of Shoulder Dystocia Management: a Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Herne, Germany, 44625
        • Dept. OBGYN Ruhr University Bochum
      • Herne, Germany, 44625
        • Dept. OBGYN, Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • informed consent

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Time
Time Frame: 30 minutes
Time probands need to perform all test tasks
30 minutes
Global Rating Scale
Time Frame: 30 minutes
Predefined score including confidence, speed, and manual capacity to perform test tasks
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clemens Tempfer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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