Pregnant Obese Women and Fetal Ultrasound Quality. (EPOWUS)

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.

Study Overview

• Status: Completed
• Conditions: Pregnant Women; Obese Women
• Intervention / Treatment: Device: ultrasound propagation velocities, ultrasound fetal quality

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 Type: Interventional
• Enrollment (Actual): 596
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand
  • Lyon, France
    • Hôpital de la croix Rousse - Hospices Civils de Lyon
  • Lyon, France
    • Hôpital Femme Mére Enfant - Hospices Civils de Lyon
  • Montpellier, France
    • Hôpital Arnaud de Villeneuve - CHU de Montpellier
  • Paris, France
    • Hôpital Cochin - Assistance Publique - Hôpitaux de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body mass index>30
• Between 20 and 25 weeks of gestation

Exclusion Criteria:

• Multiple pregnancy
• Uterine scare

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: free ultrasound propagation velocity; ultrasound exams will be performed using several ultrasound propagation velocities	Device: ultrasound propagation velocities, ultrasound fetal quality; 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.
No Intervention: conventional ultrasound propagation velocity; ultrasound exams will be performed using the 1540m/s conventional celerity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Amélie Delabaere, MD, PhD, CHU de Clermont-Ferrand

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): October 19, 2024
• Study Completion (Actual): October 19, 2024

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: image quality; obese women; fetal ultrasound; ultrasound propagation velocity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: PHRC IR 2018 DELABAERE; 2018-A03478-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No