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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03478-47 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| free ultrasound propagation velocity | Experimental | ultrasound 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound propagation velocities, ultrasound fetal quality | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| image quality of fetal ultrasound exam | Quality will be assessed by calculating Salomon's score for each image. | 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. | second trimester and third trimester ultrasound exam |
| Measure | Description | Time Frame |
|---|---|---|
| use of supplementary ultrasound exams in order to assess completeness | description of each modality of supplemental ultrasound exam | through study completion, an average of 1 year |
| description of ultrasonographist method in order to improve ultrasound exam |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amélie Delabaere, MD, PhD | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | 63000 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34548341 | Derived | 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. |
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Scans will be evaluated by independent experts who had not performed the exams. Scans will be anonymized and ultrasound propagation velocity will not be reported on the images.
|
description of modality |
| through study completion, an average of 1 year |
| economic analysis of the intervention | cost-effectiveness analysis | through study completion, an average of 1 year |
| Hôpital de la Croix Rousse - Hospices Civils de Lyon |
| Lyon |
| France |
| Hôpital Femme Mére Enfant - Hospices Civils de Lyon | Lyon | France |
| Hôpital Arnaud de Villeneuve - CHU de Montpellier | Montpellier | France |
| Hôpital Cochin - Assistance Publique - Hôpitaux de Paris | Paris | France |