Theoretical Compared With hands-on Training of Vaginal Breech Management

Ruhr University of Bochum

Status and phase: Completed; Phase 3

Conditions: Vaginal Abnormality - Baby Delivered

Treatments: Other: hands-on training; Other: frontal teaching

Study type: Interventional

Funder types: Other

Identifiers

NCT01812304

VB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• informed consent
• able to understand German
• Medical student

Exclusion criteria

• significant language barrier
• previous experience with vaginal breech training

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 2 patient groups

hands-on training

Experimental group

Description:

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

Treatment:

Other: hands-on training

frontal teaching

Active Comparator group

Description:

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

Treatment:

Other: frontal teaching