Theoretical Compared With hands-on Training of Vaginal Breech Management

July 7, 2022 updated by: Clemens Tempfer, Ruhr University of Bochum

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44623
        • Ruhr University Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • informed consent
  • able to understand German
  • Medical student

Exclusion criteria:

  • significant language barrier
  • previous experience with vaginal breech training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hands-on training
probands perform predefined maneuvers to manage a vaginal breech hands-on after one instruction
Other: hands-on training
the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech
Active Comparator: frontal teaching
Probands perform predefined maneuvers to resolve a vaginal breech after forntal teaching
Other: frontal teaching
one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSATS Score
Time Frame: 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)
probands are tested after training within an hour

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
confidence, speed, self assessment
Time Frame: immediately after training and 72 hours later
immediately after training and 72 hours later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Clemens Tempfer, MD, Ruhr University Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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