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

NCT ID: NCT03105544

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Improving Obstetric Ultrasound Skills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

simulation-based training

Intervention Type OTHER

As described under group descriptions

Control

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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simulation-based training

As described under group descriptions

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Copenhagen Academy for Medical Education and Simulation

OTHER

Sponsor Role lead

Responsible Party

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Lisbeth Andreasen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann Tabor, DMSc

Role: STUDY_DIRECTOR

Copenhagen University Hospital at Herlev

Locations

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Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Departments of Gynecology and Obstetrics, Hillerød Hospital

Hillerød, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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OBSTSIM

Identifier Type: -

Identifier Source: org_study_id

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