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Completed

NCT Number: NCT01618565

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

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.

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Key information

Conditions

Shoulder Dystocia Dystocia Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept. OBGYN Ruhr University Bochum, Herne, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent

Exclusion criteria

  • none

Treatment and study plan

Hands-On Training

Procedure

one-time, 30 minute hands-on training

Demonstration

Procedure

30 minutes passive training

Primary outcomes

  1. 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 outcomes

  1. Performance Time

    Time frame: 30 minutes

    Time probands need to perform all test tasks

  2. Global Rating Scale

    Time frame: 30 minutes

    Predefined score including confidence, speed, and manual capacity to perform test tasks

Sponsors and collaborators

Lead sponsor

Clemens Tempfer

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 13, 2012
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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