EPOWUS: Pregnant Obese Women and Fetal Ultrasound Quality.

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT04212234

Collaborator

(none)

640

Enrollment

Locations

Arms

Anticipated Duration (Months)

128

Patients Per Site

6.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obese Women Pregnant Women	Device: ultrasound propagation velocities, ultrasound fetal quality	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

640 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes 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.

Primary Purpose:

Diagnostic

Official Title:

Echography in Pregnant Obese Women and Ultrasound Speed.

Actual Study Start Date :

Dec 2, 2019

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

image quality of fetal ultrasound exam [second trimester and third trimester ultrasound exam]
Quality will be assessed by calculating Salomon's score for each image.
completeness of fetal ultrasound exam [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.

Secondary Outcome Measures

use of supplementary ultrasound exams in order to assess completeness [through study completion, an average of 1 year]
description of each modality of supplemental ultrasound exam
description of ultrasonographist method in order to improve ultrasound exam [through study completion, an average of 1 year]
description of modality
economic analysis of the intervention [through study completion, an average of 1 year]
cost-effectiveness analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Multiple pregnancy
Uterine scare

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand	Clermont-Ferrand	France	63000
2	Hôpital de la Croix Rousse - Hospices Civils de Lyon	Lyon	France
3	Hôpital Femme Mére Enfant - Hospices Civils de Lyon	Lyon	France
4	Hôpital Arnaud de Villeneuve - CHU de Montpellier	Montpellier	France
5	Hôpital Cochin - Assistance Publique - Hôpitaux de Paris	Paris	France

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Amélie Delabaere, MD, PhD, CHU de Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT04212234

Other Study ID Numbers:

PHRC IR 2018 DELABAERE
2018-A03478-47

First Posted:

Dec 26, 2019

Last Update Posted:

Jan 21, 2020

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Clermont-Ferrand

fetal ultrasound

ultrasound propagation velocity

image quality

obese women

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Jan 21, 2020