Pregnancy RelatedEPICEANCT03812471
Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
A study testing 3D volume acquisitions and 2D standard measurements and 3D volumes acquisitions in people with Pregnancy Related, run by Philips Clinical & Medical Affairs Global at 1 site in France.
Trial summary
In the proposed clinical investigation, the investigational device (BabySize3D) will provide automated plane extraction and automated biometry measurements from 3D US volumes. The results obtained from the investigational software Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- 3D volume acquisitions and 2D standard measurements and 3D volumes acquisitions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2018to 17 Mar 2023
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- evolutive pregnancy with one fetus with a Gestational Age between 16 and 30 weeks
- aged between 18 and 65 years.
- social welfare benefit recipient
- willing and able to provide informed consent
Who cannot join
- under 18 years old
- multiple pregnancy
- over 18 years old and mentioned in French law articles L.1126-6 et L-1126-8,
- fetal malformation or suspected fetal malformation
- technical conditions that do not allow for standard fetal biometry (abdominal wall, fetal position, BMI > 25 kg/m2)
- fetal biometry non indicated in the standard pregnancy follow-up
- unwilling or unable to provide informed consent (e. g. physical, mental disability or linguistic factor that compromises patient information)
Trial locations and contacts
1 site in 1 country.
About this study
In the proposed clinical investigation, the investigational device (BabySize3D) will provide automated plane extraction and automated biometry measurements from 3D US volumes. The results obtained from the investigational software
- Conditions
- Pregnancy Related
- Being tested
- 3D volume acquisitions, 2D standard measurements and 3D volumes acquisitions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D volume acquisitionsDevice
2 abdominal volumes 2 thigh volumes 2 head volumes
2D standard measurements and 3D volumes acquisitionsDevice
- 1 abdomen circumference measurement
- 1 femur length measurement
- 1 head circumference measurement
- 1 bi-parietal diameter measurement
- 1 abdominal volume
- 1 thigh volume
- 1 head volume
| Study group | Role | What they receive |
|---|---|---|
| Main study: 3D volumes acquisitions | Experimental | 3D volume acquisitions Receives: Device: 3D volume acquisitions |
| Ancillary study: 2D and 3D acquisitions | Experimental | 2D standard measurements and 3D volumes acquisitions Receives: Device: 2D standard measurements and 3D volumes acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bi-parietal diameter in mm.
The bi-parietal diameter in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
Measured: Day 1
Head circumference in mm
The Head circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
Measured: Day 1
Abdominal circumference in mm
The Abdominal circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
Measured: Day 1
Femur length in mm
The Femur length in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported
Measured: Day 1
Secondary outcomes (24)
Failure rate of the automated measurements
Failure rate of the automated measurements
Measured: Day 1
Exam and post-processing duration
Exam and post-processing duration
Measured: Day 1
Difference of scores of the 2D standard cephalic plane and cephalic plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
The cephalic plane extracted from the 3D volume and the 2D standard cephalic plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.
Measured: Day 1
Difference of scores of the 2D standard abdominal plane and abdominal plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
The abdominal plane extracted from the 3D volume and the 2D standard abdominal plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.
Measured: Day 1
Difference of scores of the 2D standard femoral plane and femoral plane extracted from the 3D volume, based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
The femoral plane extracted from the 3D volume and the 2D standard femoral plane will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.
Measured: Day 1
Difference of scores of (i) the 2D standard cephalic plane and of (ii) the frames of a sequence of 2D images including the fetus head (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
The 2D standard cephalic plane and the frames of a sequence of 2D images including the fetus head will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.
Measured: Day 1
Difference of scores of (i) the 2D standard abdominal plane and of (ii) the frames of a sequence of 2D images including the fetus abdomen (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
The 2D standard abdominal plane and the frames of a sequence of 2D images including the fetus abdomen will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.
Measured: Day 1
Difference of scores of (i) the 2D standard femoral plane and of (ii) the frames of a sequence of 2D images including the fetus femur (cine-loop), based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
The 2D standard femoral plane and the frames of a sequence of 2D images including the fetus femur will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.
Measured: Day 1
Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)
The intraclass correlation coefficient of the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.
Measured: Day 1
Bland-Altman representation of the bi-parietal diameter in mm (same operator)
A Bland-Altman representation of the the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.
Measured: Day 1
Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)
The intraclass correlation coefficient of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.
Measured: Day 1
Bland-Altman representation of the bi-parietal diameter in mm (different operators)
A Bland-Altman representation of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.
Measured: Day 1
Intraclass correlation coefficient of the head circumference in mm (same operator)
the intraclass correlation coefficient of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.
Measured: Day 1
Bland-Altman representation of the head circumference in mm (same operator)
A Bland-Altman representation of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.
Measured: Day 1
Intraclass correlation coefficient of the head circumference in mm (different operators)
The intraclass correlation coefficient of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.
Measured: Day 1
Bland-Altman representation of the head circumference in mm (different operators)
A Bland-Altman representation of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.
Measured: Day 1
Intraclass correlation coefficient of the abdominal circumference in mm (same operator)
The intraclass correlation coefficient of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.
Measured: Day 1
Bland-Altman representation of the abdominal circumference in mm (same operator)
A Bland-Altman representation of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.
Measured: Day 1
Intraclass correlation coefficient of the abdominal circumference in mm (different operators)
The intraclass correlation coefficient of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.
Measured: Day 1
Bland-Altman representation of the abdominal circumference in mm (different operators)
A Bland-Altman representation of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators built.
Measured: Day 1
Intraclass correlation coefficient of the femoral length in mm (same operator)
The intraclass correlation coefficient of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.
Measured: Day 1
Bland-Altman representation of the femoral length in mm (same operator)
A Bland-Altman representation of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.
Measured: Day 1
Title: Intraclass correlation coefficient of the femoral length in mm (different operators)
The intraclass correlation coefficient of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.
Measured: Day 1
Bland-Altman representation of the femoral length in mm (different operators)
A Bland-Altman representation of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start23 Oct 2018
- Primary completion11 Mar 2021
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaëlle Gaëlle AMBROISE-GRANDJEAN, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812471
- Sponsor's protocol ID
- ICBE-2-24301
- Acronym
- EPICEA
- Status last verified
- Apr 2023
- First submitted
- 6 Sep 2018
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ambroise Grandjean G, Hossu G, Banasiak C, Ciofolo-Veit C, Raynaud C, Rouet L, Morel O, Beaumont M. Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study. BMJ Open. 2019 Dec 15;9(12):e031777. doi: 10.1136/bmjopen-2019-031777.
PubMed 31843832
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
- ClinicalTrials.gov ID
- NCT03812471
- Acronym / sponsor ID
- EPICEA / ICBE-2-24301
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 23 Jan 2019 (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.
In the proposed clinical investigation, the investigational device (BabySize3D) will provide automated plane extraction and automated biometry measurements from 3D US volumes. The results obtained from the investigational software
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main study: 3D volumes acquisitions | Experimental | Device: 3D volume acquisitions3D volume acquisitions |
| Ancillary study: 2D and 3D acquisitions | Experimental | Device: 2D standard measurements and 3D volumes acquisitions2D standard measurements and 3D volumes acquisitions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- evolutive pregnancy with one fetus with a Gestational Age between 16 and 30 weeks
- aged between 18 and 65 years.
- social welfare benefit recipient
- willing and able to provide informed consent
Key exclusion criteria (7 listed)
- under 18 years old
- multiple pregnancy
- over 18 years old and mentioned in French law articles L.1126-6 et L-1126-8,
- fetal malformation or suspected fetal malformation
- technical conditions that do not allow for standard fetal biometry (abdominal wall, fetal position, BMI > 25 kg/m2)
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 |
|---|---|---|
| 3D volume acquisitions2 abdominal volumes 2 thigh volumes 2 head volumes | Device | Main study: 3D volumes acquisitions |
| 2D standard measurements and 3D volumes acquisitions* 1 abdomen circumference measurement * 1 femur length measurement * 1 head circumference measurement * 1 bi-parietal diameter measurement * 1 abdominal volume * 1 thigh volume * 1 head volume | Device | Ancillary study: 2D and 3D acquisitions |
Primary outcome
Bi-parietal diameter in mm.
Time frame: Day 1
The bi-parietal diameter in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
Head circumference in mm
Time frame: Day 1
The Head circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
Abdominal circumference in mm
Time frame: Day 1
The Abdominal circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.
Femur length in mm
Time frame: Day 1
The Femur length in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported
24 secondary outcomes
Failure rate of the automated measurements
Time frame: Day 1
Exam and post-processing duration
Time frame: Day 1
Difference of scores of the 2D standard cephalic plane and cephalic plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
Time frame: Day 1
Difference of scores of the 2D standard abdominal plane and abdominal plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
Time frame: Day 1
Difference of scores of the 2D standard femoral plane and femoral plane extracted from the 3D volume, based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
Time frame: Day 1
Difference of scores of (i) the 2D standard cephalic plane and of (ii) the frames of a sequence of 2D images including the fetus head (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
Time frame: Day 1
Difference of scores of (i) the 2D standard abdominal plane and of (ii) the frames of a sequence of 2D images including the fetus abdomen (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
Time frame: Day 1
Difference of scores of (i) the 2D standard femoral plane and of (ii) the frames of a sequence of 2D images including the fetus femur (cine-loop), based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)
Time frame: Day 1
Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)
Time frame: Day 1
Bland-Altman representation of the bi-parietal diameter in mm (same operator)
Time frame: Day 1
Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)
Time frame: Day 1
Bland-Altman representation of the bi-parietal diameter in mm (different operators)
Time frame: Day 1
Intraclass correlation coefficient of the head circumference in mm (same operator)
Time frame: Day 1
Bland-Altman representation of the head circumference in mm (same operator)
Time frame: Day 1
Intraclass correlation coefficient of the head circumference in mm (different operators)
Time frame: Day 1
Bland-Altman representation of the head circumference in mm (different operators)
Time frame: Day 1
Intraclass correlation coefficient of the abdominal circumference in mm (same operator)
Time frame: Day 1
Bland-Altman representation of the abdominal circumference in mm (same operator)
Time frame: Day 1
Intraclass correlation coefficient of the abdominal circumference in mm (different operators)
Time frame: Day 1
Bland-Altman representation of the abdominal circumference in mm (different operators)
Time frame: Day 1
Intraclass correlation coefficient of the femoral length in mm (same operator)
Time frame: Day 1
Bland-Altman representation of the femoral length in mm (same operator)
Time frame: Day 1
Title: Intraclass correlation coefficient of the femoral length in mm (different operators)
Time frame: Day 1
Bland-Altman representation of the femoral length in mm (different operators)
Time frame: Day 1
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 Apr 2023.
- Derived from this study: PubMed 31843832Ambroise Grandjean G, Hossu G, Banasiak C, Ciofolo-Veit C, Raynaud C, Rouet L, Morel O, Beaumont M. Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition (EPICEA): protocol for a prospective cross-sectional study. BMJ Open. 2019 Dec 15;9(12):e031777. doi: 10.1136/bmjopen-2019-031777.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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.
Gaëlle Gaëlle AMBROISE-GRANDJEAN principal investigator
CHRU de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D volume acquisitions and 2D standard measurements and 3D volumes acquisitions in people with Pregnancy Related, run by Philips Clinical & Medical Affairs Global at 1 site in France.
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 4 inclusion and 7 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 Apr 2023. 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 France. 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?
Bi-parietal diameter in mm. (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03812471, which also lists 1 linked publication.
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 Apr 2023.