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

Improving Obstetric Ultrasound Skills Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105544
• Other study ID #: OBSTSIM
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: June 2018
• Source: Copenhagen Academy for Medical Education and Simulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Improving Obstetric Ultrasound Skills

Intervention

Other:
• simulation-based training
As described under group descriptions

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Copenhagen
Denmark	Departments of Gynecology and Obstetrics, Hillerød Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen Academy for Medical Education and Simulation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of estimated fetal weight by ultrasound.	percentage error of fell weight estimate compared to actual fetal weight	1 month
Secondary	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