Pregnant Obese Women and Fetal Ultrasound Quality.

Not Applicable

Completed

• Conditions: Obese Women; Pregnant Women

• Registration Number: NCT04212234
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2019-08-30
• Study Start: 2019-12-02
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-26
• Primary Completion: 2024-10-19
• Study Completion: 2024-10-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 596

Inclusion Criteria

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

Exclusion Criteria

• Multiple pregnancy
• Uterine scare

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, 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