Ultrasonography, PrenatalAuto-2TNCT04441866
Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound
A study testing Automated algorithms and Standard technique in people with Ultrasonography, Prenatal, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
This study aims to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, during the second trimester ultrasound scan. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Prenatal
- What is being tested?
- Automated algorithms and Standard technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2020to 30 Apr 2021
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy 19+0-21+6 weeks
- Live fetus
- No fetal abnormalities
Who cannot join
- Multiple pregnancy
- Intrauterine fetal death
- Fetal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, during the second trimester ultrasound scan.
Read the detailed description
In recent years in many ultrasound equipment were fitted with automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy. Although there are studies that have assessed the application of these algorithms in terms of repeatability of the measurements made, or of possibility of acquiring diagnostic planes, there are no randomized controlled studies that evaluated their impact on the second trimester ultrasound scan.
The aim of the study is to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, in terms of:
- duration of the ultrasound scan
- quality of biometric measurements
- quality of the diagnostic planes
- operator satisfaction
- Conditions
- Ultrasonography, Prenatal
- Being tested
- Automated algorithms, Standard technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated algorithmsDiagnostic test
Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
Standard techniqueDiagnostic test
Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
| Study group | Role | What they receive |
|---|---|---|
| Automated algorithms | Active comparator | Automated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes Receives: Diagnostic Test: Automated algorithms |
| Standard technique | Placebo comparator | Standard 2D assessment Receives: Diagnostic Test: Standard technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of ultrasound examination
Duration of ultrasound examination in minutes
Measured: During ultrasound examination
Secondary outcomes (3)
Quality score of fetal biometry
Score described by Salomon et al. 2006: range from 0 (worst) to 16 (best)
Measured: During ultrasound examination
Quality score of fetal diagnostic planes
Score described by Salomon et al. 2008: range from 0 (worst) to 32 (best)
Measured: During ultrasound examination
Operator satisfaction
Visual analogue scale: from 0 (worst) to 32 (best)
Measured: During ultrasound examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start19 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasonography, PrenatalStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Prefumo, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441866
- Sponsor's protocol ID
- NP3574
- Acronym
- Auto-2T
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2020
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Analysis Algorithms in Second Trimester Obstetric Ultrasound
- ClinicalTrials.gov ID
- NCT04441866
- Acronym / sponsor ID
- Auto-2T / NP3574
- Conditions
- Ultrasonography, Prenatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Jun 2020 (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.
This study aims to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, during the second trimester ultrasound scan.
Detailed description
In recent years in many ultrasound equipment were fitted with automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy. Although there are studies that have assessed the application of these algorithms in terms of repeatability of the measurements made, or of possibility of acquiring diagnostic planes, there are no randomized controlled studies that evaluated their impact on the second trimester ultrasound scan.
The aim of the study is to evaluate the effect of the use of automated algorithms for the measurement of fetal biometry, and for the reconstruction of standard planes of fetal anatomy, compared with the standard ultrasound technique, in terms of:
- duration of the ultrasound scan
- quality of biometric measurements
- quality of the diagnostic planes
- operator satisfaction
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated algorithms | Active comparator | Diagnostic Test: Automated algorithmsAutomated 3D techniques in measuring fetal biometry and reconstructing standard anatomical planes |
| Standard technique | Placebo comparator | Diagnostic Test: Standard techniqueStandard 2D assessment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton pregnancy 19+0-21+6 weeks
- Live fetus
- No fetal abnormalities
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Intrauterine fetal death
- Fetal abnormalities
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 |
|---|---|---|
| Automated algorithmsAutomated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy | Diagnostic test | Automated algorithms |
| Standard techniqueStandard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy | Diagnostic test | Standard technique |
Primary outcome
Duration of ultrasound examination
Time frame: During ultrasound examination
Duration of ultrasound examination in minutes
3 secondary outcomes
Quality score of fetal biometry
Time frame: During ultrasound examination
Quality score of fetal diagnostic planes
Time frame: During ultrasound examination
Operator satisfaction
Time frame: During ultrasound examination
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 14 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated algorithms and Standard technique in people with Ultrasonography, Prenatal, run by Università degli Studi di Brescia at 1 site in Italy.
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 3 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. Some participants in this study may receive a placebo. 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?
Duration of ultrasound examination (time frame: During ultrasound examination). 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 14 Jun 2021.