Theoretical Compared With hands-on Training of Vaginal Breech Management

Phase 3

Completed

• Conditions: Vaginal Abnormality - Baby Delivered
• Interventions: Other: hands-on training; Other: frontal teaching

• Registration Number: NCT01812304
• Lead Sponsor: Ruhr University of Bochum

Brief 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-18
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• informed consent
• able to understand German
• Medical student

Exclusion criteria:

• significant language barrier
• previous experience with vaginal breech training

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hands-on training	hands-on training	probands perform predefined maneuvers to manage a vaginal breech hands-on after one instruction
frontal teaching	frontal teaching	Probands perform predefined maneuvers to resolve a vaginal breech after forntal teaching

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
OSATS Scores	72 Hours after training	identical to primary outcome, but 72 hours later

Trial Locations

Locations (1)

Ruhr University Bochum; 🇩🇪 Bochum, NRW, Germany