Improving Detection of Fetuses at Risk - Who Needs Systematic Training?

Detection of growth restricted fetuses relies primarily on abdominal ultrasound examinations during pregnancy. Many clinicians, however, have not received systematic training and may therefore perform inadequately. We wish to examine, whether systematic, simulation-based training can improve diagnostic accuracy of estimated fetal weight by ultrasound at different levels of clinical experience.

Study Overview

• Status: Completed
• Conditions: Improving Obstetric Ultrasound Skills
• Intervention / Treatment: Other: simulation-based training

Detailed Description

Participants are physicians working at obstetric departments. Participant characteristics (age, experience in years and number of monthly scans) are recorded. Participants perform two abdominal growth scans prior to randomization and estimated fetal weight is compared to birth weight. Mean absolute percentage error is calculated as a measure of diagnostic accuracy.

Participants are then randomized to either control (no intervention) or intervention. The latter group receives training on the Metaphor Scantrainer trans abdominal ultrasound simulator until they pass a previously validated test. After completing the training the participants use a mannikin to practice systematic approach and 'knobology'.

All participants then perform another two growth scans. Diagnostic accuracy before and after the intervention or control period is compared.

We wish to examine the effect of systematic training on the diagnostic accuracy of estimated fetal weight by ultrasound across different levels of clinical experience.

If an effect can be found in the inexperienced participants, simulation-based training in obstetric ultrasound could be implemented as a part of basic obstetric training and/or as a means of maintaining skills.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Copenhagen University Hospital
  • Hillerød, Denmark, 3400
    • Departments of Gynecology and Obstetrics, Hillerød Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• proficiency in the Danish language
• no prior experience with obstetric ultrasound simulation
• doctors who work within the field of gynecology and obstetrics

Exclusion Criteria:

• lack of proficiency in the Danish language
• prior experience with obstetric ultrasound simulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No intervention.
EXPERIMENTAL: Intervention; Simulation-based training: Virtual-reality simulation training on the Medaphor Scantrainer Transabdominal Simulator until expert level is reached. Then training on a physical mannikin until an average OSAUS-score of 3 or more is attained.	Other: simulation-based training; As described under group descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of estimated fetal weight by ultrasound.	percentage error of fell weight estimate compared to actual fetal weight	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratings of ultrasound images	Images are rated using the image-scoring method by Salomon et al. (Salomon et al. Feasibility and reproducibility of an image-scoring method for quality control of fetal biometry in the second trimester. Ultrasound Obstet Gynecol 2006;27;34-40) The images are scores on the number of landmarks, correct caliper placement and image optimization. A minimum of 0 and a maximum of 16 points can be given (best possible score).	1 month

Collaborators and Investigators

• Sponsor: Copenhagen Academy for Medical Education and Simulation
• Investigators: Study Director: Ann Tabor, DMSc, Copenhagen University Hospital at Herlev

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): March 1, 2018

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: intrauterine growth restriction; simulation-based training; obstetric ultrasound; ultrasound simulation
• Other Study ID Numbers: OBSTSIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No