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

NCT03105544 | Completed

• 1 other identifier: OBSTSIM
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Improving Obstetric Ultrasound Skills

Keywords

simulation-based training; obstetric ultrasound; intrauterine growth restriction; ultrasound simulation

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of estimated fetal weight by ultrasound.

  percentage error of fell weight estimate compared to actual fetal weight

  1 month

Secondary Outcomes (1)

• Ratings of ultrasound images

  1 month

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention.

Interventions

simulation-based training OTHER

As described under group descriptions

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen Academy for Medical Education and Simulation: lead

Study Sites (2)

Copenhagen University Hospital

Copenhagen, Denmark

Location

Departments of Gynecology and Obstetrics, Hillerød Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann Tabor, DMSc

  Copenhagen University Hospital at Herlev

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: April 10, 2017
• Study Start: July 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

DK (2)