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

NCT ID: NCT01618565

Last Updated: 2022-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Shoulder Dystocia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hands-On Training

30 minutes hands-on training of maneuvers to manage shoulder dystocia

Group Type EXPERIMENTAL

Hands-On Training

Intervention Type PROCEDURE

one-time, 30 minute hands-on training

Demonstration

30 minutes passive training by watching an expert instructor explain and perform maneuvers to manage shoulder dystocia

Group Type ACTIVE_COMPARATOR

Demonstration

Intervention Type PROCEDURE

30 minutes passive training

Interventions

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Hands-On Training

one-time, 30 minute hands-on training

Intervention Type PROCEDURE

Demonstration

30 minutes passive training

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* informed consent

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clemens Tempfer

OTHER

Sponsor Role lead

Responsible Party

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Clemens Tempfer

Department head ObGyn

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Dept. OBGYN Ruhr University Bochum

Herne, , Germany

Site Status

Dept. OBGYN, Ruhr University Bochum

Herne, , Germany

Site Status

Countries

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Germany

References

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Buerkle B, Pueth J, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective structured assessment of technical skills evaluation of theoretical compared with hands-on training of shoulder dystocia management: a randomized controlled trial. Obstet Gynecol. 2012 Oct;120(4):809-14. doi: 10.1097/AOG.0b013e31826af9a9.

Reference Type RESULT
PMID: 22996098 (View on PubMed)

Other Identifiers

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SD-1

Identifier Type: -

Identifier Source: org_study_id

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