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OpenTrials
Completed

NCT Number: NCT03105544

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Simulation-based training

Other

As described under group descriptions

Primary outcomes

  1. Diagnostic accuracy of estimated fetal weight by ultrasound.

    Time frame: 1 month

    percentage error of fell weight estimate compared to actual fetal weight

Secondary outcomes

  1. Ratings of ultrasound images

    Time frame: 1 month

    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).

Sponsors and collaborators

Lead sponsor

Copenhagen Academy for Medical Education and Simulation

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2017
Registry last updated
Jun 28, 2018

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

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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.

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