Obese WomenEPOWUSNCT04212234
Pregnant Obese Women and Fetal Ultrasound Quality.
A study testing ultrasound propagation velocities, ultrasound fetal quality in people with Obese Women and Pregnant Women, run by University Hospital, Clermont-Ferrand at 5 sites in France.
Trial summary
Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obese Women, Pregnant Women
- What is being tested?
- ultrasound propagation velocities, ultrasound fetal quality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 5 sitesFrance
- Study dates
- 2 Dec 2019to 19 Oct 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index>30
- Between 20 and 25 weeks of gestation
Who cannot join
- Multiple pregnancy
- Uterine scare
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
Hôpital de la Croix Rousse - Hospices Civils de Lyon
Lyon
Hôpital Femme Mére Enfant - Hospices Civils de Lyon
Lyon
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier
Hôpital Cochin - Assistance Publique - Hôpitaux de Paris
Paris
About this study
Official title: Echography in Pregnant Obese Women and Ultrasound Speed.
Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. In fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. US velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction The main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.
Read the detailed description
Obese pregnant women will be included before the second trimester fetal ultrasound examination.
Women will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam.
In the control group, exam will be performed using the conventional ultrasound velocity.
An exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached.
The protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline.
All scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al.
- Conditions
- Obese Women, Pregnant Women
- Being tested
- ultrasound propagation velocities, ultrasound fetal quality
- Keywords
- fetal ultrasound, ultrasound propagation velocity, image quality, obese women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound propagation velocities, ultrasound fetal qualityDevice
Obese pregnant women will be included before the second trimester fetal ultrasound examination.
Women will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam.
In the control group, exam will be performed using the conventional ultrasound velocity.
An exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached.
The protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline.
All scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al.
| Study group | Role | What they receive |
|---|---|---|
| free ultrasound propagation velocity | Experimental | ultrasound exams will be performed using several ultrasound propagation velocities Receives: Device: ultrasound propagation velocities, ultrasound fetal quality |
| conventional ultrasound propagation velocity | No intervention | ultrasound exams will be performed using the 1540m/s conventional celerity |
What is being measured
The primary outcome is the main question the study is designed to answer.
image quality of fetal ultrasound exam
Quality will be assessed by calculating Salomon's score for each image.
Measured: second trimester and third trimester ultrasound exam
completeness of fetal ultrasound exam
completeness will be assessed by the number of the recommended images which could have been registered during the first ultrasound exam in each trimester.
Measured: second trimester and third trimester ultrasound exam
Secondary outcomes (3)
use of supplementary ultrasound exams in order to assess completeness
description of each modality of supplemental ultrasound exam
Measured: through study completion, an average of 1 year
description of ultrasonographist method in order to improve ultrasound exam
description of modality
Measured: through study completion, an average of 1 year
economic analysis of the intervention
cost-effectiveness analysis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start2 Dec 2019
- Primary completion19 Oct 2024
- Study completion19 Oct 2024
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 Obese WomenStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amélie Delabaere, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212234
- Sponsor's protocol ID
- PHRC IR 2018 DELABAERE
- Other IDs
- 2018-A03478-47
- Acronym
- EPOWUS
- Status last verified
- Jan 2025
- First submitted
- 30 Aug 2019
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delabaere A, Chauveau B, Lemery D, Ollier A, Guiguet-Auclair C, Mourgues C, Legrand A. Protocol for the e-POWUS Project: multicentre blinded-randomised controlled trial of ultrasound speed choice to improve sonography quality in pregnant women with obesity. BMJ Open. 2021 Sep 21;11(9):e038684. doi: 10.1136/bmjopen-2020-038684.
PubMed 34548341
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echography in Pregnant Obese Women and Ultrasound Speed.
- ClinicalTrials.gov ID
- NCT04212234
- Acronym / sponsor ID
- EPOWUS / PHRC IR 2018 DELABAERE
- Conditions
- Obese Women, Pregnant Women
- Keywords
- fetal ultrasound, ultrasound propagation velocity, image quality, obese women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 19 Oct 2024 (actual)
- Study completion
- 19 Oct 2024 (actual)
- First posted
- 26 Dec 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.
Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. In fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. US velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction The main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.
Detailed description
Obese pregnant women will be included before the second trimester fetal ultrasound examination.
Women will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam.
In the control group, exam will be performed using the conventional ultrasound velocity.
An exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached.
The protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline.
All scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| free ultrasound propagation velocity | Experimental | Device: ultrasound propagation velocities, ultrasound fetal qualityultrasound exams will be performed using several ultrasound propagation velocities |
| conventional ultrasound propagation velocity | No intervention | –ultrasound exams will be performed using the 1540m/s conventional celerity |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index>30
- Between 20 and 25 weeks of gestation
Key exclusion criteria (2 listed)
- Multiple pregnancy
- Uterine scare
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 |
|---|---|---|
| ultrasound propagation velocities, ultrasound fetal qualityObese pregnant women will be included before the second trimester fetal ultrasound examination. Women will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam. In the control group, exam will be performed using the conventional ultrasound velocity. An exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached. The protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline. All scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al. | Device | free ultrasound propagation velocity |
Primary outcome
image quality of fetal ultrasound exam
Time frame: second trimester and third trimester ultrasound exam
Quality will be assessed by calculating Salomon's score for each image.
completeness of fetal ultrasound exam
Time frame: second trimester and third trimester ultrasound exam
completeness will be assessed by the number of the recommended images which could have been registered during the first ultrasound exam in each trimester.
3 secondary outcomes
use of supplementary ultrasound exams in order to assess completeness
Time frame: through study completion, an average of 1 year
description of ultrasonographist method in order to improve ultrasound exam
Time frame: through study completion, an average of 1 year
economic analysis of the intervention
Time frame: through study completion, an average of 1 year
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 3 Jan 2025.
- Derived from this study: PubMed 34548341Delabaere A, Chauveau B, Lemery D, Ollier A, Guiguet-Auclair C, Mourgues C, Legrand A. Protocol for the e-POWUS Project: multicentre blinded-randomised controlled trial of ultrasound speed choice to improve sonography quality in pregnant women with obesity. BMJ Open. 2021 Sep 21;11(9):e038684. doi: 10.1136/bmjopen-2020-038684.
- Individual participant dataSharing planned: No
Related trials for Obese Women
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Active, not recruiting
Family Functioning in Obesity Treatment for Mexican Americans
Obesity
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
Amélie Delabaere, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound propagation velocities, ultrasound fetal quality in people with Obese Women and Pregnant Women, run by University Hospital, Clermont-Ferrand at 5 sites 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 2 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 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
image quality of fetal ultrasound exam (time frame: second trimester and third trimester ultrasound exam). The study lists 2 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 NCT04212234, 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 3 Jan 2025.