NCT04212234|Completed
Pregnant Obese Women and Fetal Ultrasound Quality.
EPOWUS
Echography in Pregnant Obese Women and Ultrasound Speed.
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EPOWUS
Echography in Pregnant Obese Women and Ultrasound Speed.
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
596
1 country
5
Study Start
December 2, 2019
Actual (reported)Primary Completion
October 19, 2024
Actual (reported)Study Completion
October 19, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 19, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2019
Actual (reported)December 2, 2019
Actual (reported)December 26, 2019
Actual (reported)October 19, 2024
Actual (reported)October 19, 2024
Actual (reported)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
use of supplementary ultrasound exams in order to assess completeness
through study completion, an average of 1 year
description of ultrasonographist method in order to improve ultrasound exam
through study completion, an average of 1 year
economic analysis of the intervention
through study completion, an average of 1 year
ultrasound exams will be performed using several ultrasound propagation velocities
ultrasound exams will be performed using the 1540m/s conventional celerity
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000, France
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
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.
Amélie Delabaere, MD, PhD
University Hospital, Clermont-Ferrand
596 participants (actual enrollment reported by the registry).
First Submitted
August 30, 2019
First Posted
December 26, 2019
Study Start
December 2, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 19, 2024
Actual (reported)Study Completion
October 19, 2024
Actual (reported)Last Updated
January 3, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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