Pregnant Obese Women and Fetal Ultrasound Quality. (EPOWUS)
Primary Purpose
Obese Women, Pregnant Women
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasound propagation velocities, ultrasound fetal quality
Sponsored by

About this trial
This is an interventional diagnostic trial for Obese Women focused on measuring fetal ultrasound, ultrasound propagation velocity, image quality, obese women
Eligibility Criteria
Inclusion Criteria:
- Body mass index>30
- Between 20 and 25 weeks of gestation
Exclusion Criteria:
- Multiple pregnancy
- Uterine scare
Sites / Locations
- Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-FerrandRecruiting
- Hôpital de la Croix Rousse - Hospices Civils de Lyon
- Hôpital Femme Mére Enfant - Hospices Civils de Lyon
- Hôpital Arnaud de Villeneuve - CHU de Montpellier
- Hôpital Cochin - Assistance Publique - Hôpitaux de Paris
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
free ultrasound propagation velocity
conventional ultrasound propagation velocity
Arm Description
ultrasound exams will be performed using several ultrasound propagation velocities
ultrasound exams will be performed using the 1540m/s conventional celerity
Outcomes
Primary Outcome Measures
image quality of fetal ultrasound exam
Quality will be assessed by calculating Salomon's score for each image.
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.
Secondary Outcome Measures
use of supplementary ultrasound exams in order to assess completeness
description of each modality of supplemental ultrasound exam
description of ultrasonographist method in order to improve ultrasound exam
description of modality
economic analysis of the intervention
cost-effectiveness analysis
Full Information
NCT ID
NCT04212234
First Posted
August 30, 2019
Last Updated
January 17, 2020
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT04212234
Brief Title
Pregnant Obese Women and Fetal Ultrasound Quality.
Acronym
EPOWUS
Official Title
Echography in Pregnant Obese Women and Ultrasound Speed.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese Women, Pregnant Women
Keywords
fetal ultrasound, ultrasound propagation velocity, image quality, obese women
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
640 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
free ultrasound propagation velocity
Arm Type
Experimental
Arm Description
ultrasound exams will be performed using several ultrasound propagation velocities
Arm Title
conventional ultrasound propagation velocity
Arm Type
No Intervention
Arm Description
ultrasound exams will be performed using the 1540m/s conventional celerity
Intervention Type
Device
Intervention Name(s)
ultrasound propagation velocities, ultrasound fetal quality
Intervention 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.
Primary Outcome Measure Information:
Title
image quality of fetal ultrasound exam
Description
Quality will be assessed by calculating Salomon's score for each image.
Time Frame
second trimester and third trimester ultrasound exam
Title
completeness of fetal ultrasound exam
Description
completeness will be assessed by the number of the recommended images which could have been registered during the first ultrasound exam in each trimester.
Time Frame
second trimester and third trimester ultrasound exam
Secondary Outcome Measure Information:
Title
use of supplementary ultrasound exams in order to assess completeness
Description
description of each modality of supplemental ultrasound exam
Time Frame
through study completion, an average of 1 year
Title
description of ultrasonographist method in order to improve ultrasound exam
Description
description of modality
Time Frame
through study completion, an average of 1 year
Title
economic analysis of the intervention
Description
cost-effectiveness analysis
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index>30
Between 20 and 25 weeks of gestation
Exclusion Criteria:
Multiple pregnancy
Uterine scare
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Delabaere, Study Cordonnator Investigator
Phone
334.73.75.50.79
Email
adelabaere@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amélie Delabaere, MD, PhD
Organizational Affiliation
CHU de Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie DELABAERE, MD, PhD
Facility Name
Hôpital de la Croix Rousse - Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyril HUISSOUD, MD, PhD
Facility Name
Hôpital Femme Mére Enfant - Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérome MASSARDIER, MD, PhD
Facility Name
Hôpital Arnaud de Villeneuve - CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent FUCHS, MD, PhD
Facility Name
Hôpital Cochin - Assistance Publique - Hôpitaux de Paris
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles GRANGE, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34548341
Citation
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.
Results Reference
derived
Learn more about this trial
Pregnant Obese Women and Fetal Ultrasound Quality.
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