Back to resultsTheoretical Compared With hands-on Training of Vaginal Breech Management
Primary Purpose
Vaginal Abnormality - Baby Delivered
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
hands-on training
frontal teaching
Sponsored by
About this trial
This is an interventional other trial for Vaginal Abnormality - Baby Delivered
Eligibility Criteria
Inclusion Criteria:
- informed consent
- able to understand German
- Medical student
Exclusion criteria:
- significant language barrier
- previous experience with vaginal breech training
Sites / Locations
- Ruhr University Bochum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hands-on training
frontal teaching
Arm Description
probands perform predefined maneuvers to manage a vaginal breech hands-on after one instruction
Probands perform predefined maneuvers to resolve a vaginal breech after forntal teaching
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
OSATS Scores
identical to primary outcome, but 72 hours later
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01812304
Brief Title
Theoretical Compared With hands-on Training of Vaginal Breech Management
Official Title
Objective Structured Assessment of Technical Skills Evaluation of Theoretical Compared With hands-on Training of Shoulder Dystocia Management: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Abnormality - Baby Delivered
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hands-on training
Arm Type
Experimental
Arm Description
probands perform predefined maneuvers to manage a vaginal breech hands-on after one instruction
Arm Title
frontal teaching
Arm Type
Active Comparator
Arm Description
Probands perform predefined maneuvers to resolve a vaginal breech after forntal teaching
Intervention Type
Other
Intervention Name(s)
hands-on training
Intervention Description
the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech
Intervention Type
Other
Intervention Name(s)
frontal teaching
Intervention Description
one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.
Primary Outcome Measure Information:
Title
OSATS Score
Description
OSATS Scores are assessed on a pelvic model by a blinded assessor immediately after training (1 arm hands-on, 1 arm forntal teaching)
Time Frame
probands are tested after training within an hour
Secondary Outcome Measure Information:
Title
OSATS Scores
Description
identical to primary outcome, but 72 hours later
Time Frame
72 Hours after training
Other Pre-specified Outcome Measures:
Title
confidence, speed, self assessment
Time Frame
immediately after training and 72 hours later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
informed consent
able to understand German
Medical student
Exclusion criteria:
significant language barrier
previous experience with vaginal breech training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clemens Tempfer, MD
Organizational Affiliation
Ruhr University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruhr University Bochum
City
Bochum
State/Province
NRW
ZIP/Postal Code
44623
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24103530
Citation
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.
Results Reference
result
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Theoretical Compared With hands-on Training of Vaginal Breech Management
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