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.
1 other identifier
interventional
172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 8, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJuly 8, 2022
July 1, 2022
2 years
March 8, 2013
July 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
OSATS Scores
72 Hours after training
Other Outcomes (1)
confidence, speed, self assessment
immediately after training and 72 hours later
Study Arms (2)
hands-on training
EXPERIMENTALprobands perform predefined maneuvers to manage a vaginal breech hands-on after one instruction
frontal teaching
ACTIVE COMPARATORProbands perform predefined maneuvers to resolve a vaginal breech after forntal teaching
Interventions
the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech
one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.
Eligibility Criteria
You may qualify if:
- informed consent
- able to understand German
- Medical student
You may not qualify if:
- significant language barrier
- previous experience with vaginal breech training
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ruhr University Bochum
Bochum, North Rhine-Westphalia, 44623, Germany
Related 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 Reprod Biol. 2013 Dec;171(2):252-6. doi: 10.1016/j.ejogrb.2013.09.015. Epub 2013 Sep 25.
PMID: 24103530RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Clemens Tempfer, MD
Ruhr University Bochum
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Clemens Tempfer, MBA
Study Record Dates
First Submitted
March 8, 2013
First Posted
March 18, 2013
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
July 8, 2022
Record last verified: 2022-07