NCT01812304

Theoretical Compared With hands-on Training of Vaginal Breech Management

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

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

• Vaginal Abnormality - Baby Delivered

Interventions

Type	Name	Description
OTHER	hands-on training	the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech
OTHER	frontal teaching	one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2013-03-18
• Last updated: 2022-07-08

Locations

1 site across 1 country: Germany