Clinical trial NCT04212234: Pregnant Obese Women and Fetal Ultrasound Quality.
Official title: Echography in Pregnant Obese Women and Ultrasound Speed.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese Women
Pregnant Women
Keywords: fetal ultrasound
ultrasound propagation velocity
image quality
obese women
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 596
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Multiple pregnancy
* Uterine scare

Primary outcomes:
measure: image quality of fetal ultrasound exam
timeFrame: second trimester and third trimester ultrasound exam
measure: completeness of fetal ultrasound exam
timeFrame: second trimester and third trimester ultrasound exam
Secondary outcomes:
measure: use of supplementary ultrasound exams in order to assess completeness
timeFrame: through study completion, an average of 1 year
measure: description of ultrasonographist method in order to improve ultrasound exam
timeFrame: through study completion, an average of 1 year
measure: economic analysis of the intervention
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand
city: Lyon
country: France
facility: Hôpital de la Croix Rousse - Hospices Civils de Lyon
city: Lyon
country: France
facility: Hôpital Femme Mére Enfant - Hospices Civils de Lyon
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier
city: Paris
country: France
facility: Hôpital Cochin - Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Amélie Delabaere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.