Theoretical Compared With hands-on Training of Vaginal Breech Management

Study Overview
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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.

Official Title
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Objective Structured Assessment of Technical Skills Evaluation of Theoretical Compared With hands-on Training of Shoulder Dystocia Management: a Randomized Controlled Trial.

Conditions
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Vaginal Abnormality - Baby Delivered

Intervention / Treatment
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* Other: hands-on training
* Other: frontal teaching


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hands-on training<br>probands perform predefined maneuvers to manage a vaginal breech hands-on after one instruction | Other: hands-on training<br>* the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech<br>|
| Active Comparator: frontal teaching<br>Probands perform predefined maneuvers to resolve a vaginal breech after forntal teaching | Other: frontal teaching<br>* one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSATS Score | OSATS Scores are assessed on a pelvic model by a blinded assessor immediately after training (1 arm hands-on, 1 arm forntal teaching) | probands are tested after training within an hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSATS Scores | identical to primary outcome, but 72 hours later | 72 Hours after training |