Skip to main content
OpenTrials
Completed

NCT Number: NCT02468427

Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Delivery by Vacuum Extraction

In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal teaching using a Training Video for learning how to perform an assisted delivery by vacuum extraction on a pelvic Training model. Objective Structured Assessment of Technical Skills (OSATS) scores are the primary outcome. The investigators hypothesize that Hands-on Training is superior to a video-teaching with regard to the OSATS scores achieved by the Trainees.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. OBGYN Ruhr University Bochum

Herne, 44625, Germany

About this study

The optimal mode of Training surgical novices how to perform an assisted delivery by means of vacuum extraction is unknown. We prospectively randomize probands to a 30 min hands-on (group 1) and a 30 min demonstration (group 2) training session teaching a standardized vacuum Extraction (VE) algorithm scheme on a pelvic training model. Probands are tested with a 24 item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 48 hours, and 72 hours thereafter. OSATS scores are the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square test, and multivariable logistic regression analysis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical Student
  • no previous experience in assisted delivery
  • no previous gynecologic surgery training

Exclusion criteria

  • language barrier
  • unwillingness to participate

Treatment and study plan

hands-on teaching

Other

Training session of 30 minutes duration with every proband performing a vacuum extraction on a pelvic training model.

Frontal teaching

Other

Training session of 30 minutes duration consisting of a video which demonstrates how to perform a vacuum extraction on a pelvic training model.

Primary outcomes

  1. OSATS scores

    Time frame: 5 min after the training

    24 predefined OSATS items

Secondary outcomes

  1. OSATS scores after 48 hours

    Time frame: 48 hours after the training

    24 predefined OSATS items

  2. OSATS scores after 72 hours

    Time frame: 72 hours after the training

    24 predefined OSATS items

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Operative-Vaginal Delivery by Vacuum Extraction on a Pelvic Training Model

Acronym: VAC-OSATS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2015
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.