Theoretical Compared With hands-on Training of Vaginal Breech Management

Vaginal Abnormality - Baby Delivered Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812304
• Other study ID #: VB-01
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: November 2013

Study information

• Verified date: July 2022
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• informed consent

• able to understand German

• Medical student

Exclusion criteria:

• significant language barrier

• previous experience with vaginal breech training

Related Conditions & MeSH terms

• Congenital Abnormalities
• Vaginal Abnormality - Baby Delivered

Intervention

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

Locations

Country	Name	City	State
Germany	Ruhr University Bochum	Bochum	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	confidence, speed, self assessment		immediately after training and 72 hours later
Primary	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	OSATS Scores	identical to primary outcome, but 72 hours later	72 Hours after training