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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01812304

Enrollment

172

Registered

2013-03-18

Start date

2011-10-31

Completion date

2013-11-30

Last updated

2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Abnormality - Baby Delivered

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.

Interventions

OTHERhands-on training

the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech

OTHERfrontal teaching

one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* informed consent * able to understand German * Medical student

Exclusion criteria

* significant language barrier * previous experience with vaginal breech training

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
OSATS Scores	72 Hours after training	identical to primary outcome, but 72 hours later

Other

Measure	Time frame
confidence, speed, self assessment	immediately after training and 72 hours later

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026