Improving Obstetric Ultrasound SkillsNCT03105544
Improving Detection of Fetuses at Risk - Who Needs Systematic Training?
A study testing simulation-based training in people with Improving Obstetric Ultrasound Skills, run by Copenhagen Academy for Medical Education and Simulation at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Improving Obstetric Ultrasound Skills
- What is being tested?
- simulation-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesDenmark
- Study dates
- Jul 2016to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- proficiency in the Danish language
- no prior experience with obstetric ultrasound simulation
- doctors who work within the field of gynecology and obstetrics
Who cannot join
- lack of proficiency in the Danish language
- prior experience with obstetric ultrasound simulation
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen University Hospital
Copenhagen
Departments of Gynecology and Obstetrics, Hillerød Hospital
Hillerød, 3400
About this study
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.
Read the 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.
- Conditions
- Improving Obstetric Ultrasound Skills
- Being tested
- simulation-based training
- Keywords
- simulation-based training, obstetric ultrasound, intrauterine growth restriction, ultrasound simulation
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation-based trainingOther
As described under group descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: simulation-based training |
| Control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of estimated fetal weight by ultrasound.
percentage error of fell weight estimate compared to actual fetal weight
Measured: 1 month
Secondary outcomes (1)
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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startJul 2016
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Obstetric Ultrasound SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisbeth Andreasen, Copenhagen Academy for Medical Education and Simulation
- Investigators
- Ann Tabor, DMSc, Study director, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105544
- Sponsor's protocol ID
- OBSTSIM
- Status last verified
- Jun 2018
- First submitted
- 30 Jan 2017
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Detection of Fetuses at Risk - Who Needs Systematic Training?
- ClinicalTrials.gov ID
- NCT03105544
- Acronym / sponsor ID
- OBSTSIM
- Conditions
- Improving Obstetric Ultrasound Skills
- Keywords
- simulation-based training, obstetric ultrasound, intrauterine growth restriction, ultrasound simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: simulation-based trainingSimulation-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. |
| Control | No intervention | –No intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- proficiency in the Danish language
- no prior experience with obstetric ultrasound simulation
- doctors who work within the field of gynecology and obstetrics
Key exclusion criteria (2 listed)
- lack of proficiency in the Danish language
- prior experience with obstetric ultrasound simulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simulation-based trainingAs described under group descriptions | Other | Intervention |
Primary outcome
Diagnostic accuracy of estimated fetal weight by ultrasound.
Time frame: 1 month
percentage error of fell weight estimate compared to actual fetal weight
1 secondary outcome
Ratings of ultrasound images
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Tabor, DMSc study director
Copenhagen University Hospital at Herlev
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation-based training in people with Improving Obstetric Ultrasound Skills, run by Copenhagen Academy for Medical Education and Simulation at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of estimated fetal weight by ultrasound. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018; AzTrials last refreshed its copy on 1 Nov 2026.