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Pregnant Obese Women and Fetal Ultrasound Quality.

Echography in Pregnant Obese Women and Ultrasound Speed.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04212234
Acronym
EPOWUS
Enrollment
596
Registered
2019-12-26
Start date
2019-12-02
Completion date
2024-10-19
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Women, Pregnant Women

Keywords

fetal ultrasound, ultrasound propagation velocity, image quality, obese women

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.

Interventions

DEVICEultrasound 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.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Multiple pregnancy * Uterine scare

Design outcomes

Primary

MeasureTime frameDescription
image quality of fetal ultrasound examsecond trimester and third trimester ultrasound examQuality will be assessed by calculating Salomon's score for each image.
completeness of fetal ultrasound examsecond trimester and third trimester ultrasound examcompleteness will be assessed by the number of the recommended images which could have been registered during the first ultrasound exam in each trimester.

Secondary

MeasureTime frameDescription
use of supplementary ultrasound exams in order to assess completenessthrough study completion, an average of 1 yeardescription of each modality of supplemental ultrasound exam
description of ultrasonographist method in order to improve ultrasound examthrough study completion, an average of 1 yeardescription of modality
economic analysis of the interventionthrough study completion, an average of 1 yearcost-effectiveness analysis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026