Theoretical Compared With hands-on Training of Vaginal Breech Management

NCT ID: NCT01812304

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

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-11-30

Brief Summary

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This trial aims to assess the hypothesis that hands-on training of vaginal breech delivery on a pelvic model is significantly better in terms of a technical skills scoring system compared to frontal teaching.

Detailed Description

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Primary endpoint is a score describing technical proficiency, ie the OSATS score, consisting of 25 items. Each item, if done correctly, is awarded one point. The maximum OSATS score is 25.

Secondary endpoints are performance time in seconds, cinfidence using a scale from 1-5 with one being very confident and 5 having no confidence when performing the procedures, and self-assessment using a scale of 1-5 with 1 being the optimal grade.

This is a two-arm study. The experimental arm uses a hands-on training and the control arm a frontal teaching approach. The allocation is randomized and single-blinded.

Conditions

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Vaginal Abnormality - Baby Delivered

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

probands perform predefined maneuvers to manage a vaginal breech hands-on after one instruction

Group Type EXPERIMENTAL

hands-on training

Intervention Type OTHER

the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech

frontal teaching

Probands perform predefined maneuvers to resolve a vaginal breech after forntal teaching

Group Type ACTIVE_COMPARATOR

frontal teaching

Intervention Type OTHER

one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.

Interventions

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hands-on training

the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech

Intervention Type OTHER

frontal teaching

one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* informed consent
* able to understand German
* Medical student

Exclusion Criteria

* significant language barrier
* previous experience with vaginal breech training
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Clemens Tempfer

Prof. Dr. med. Clemens Tempfer, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clemens Tempfer, MD

Role: PRINCIPAL_INVESTIGATOR

Ruhr University Bochum

Locations

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Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Buerkle B, Rueter K, Hefler LA, Tempfer-Bentz EK, Tempfer CB. Objective Structured Assessment of Technical Skills (OSATS) evaluation of theoretical versus hands-on training of vaginal breech delivery management: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):252-6. doi: 10.1016/j.ejogrb.2013.09.015. Epub 2013 Sep 25.

Reference Type RESULT
PMID: 24103530 (View on PubMed)

Other Identifiers

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VB-01

Identifier Type: -

Identifier Source: org_study_id

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