Pregnant Obese Women and Fetal Ultrasound Quality. (EPOWUS)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Pregnant Women; Obese Women

Treatments: Device: ultrasound propagation velocities, ultrasound fetal quality

Study type: Interventional

Funder types: Other

Identifiers

NCT04212234

2018-A03478-47 (Other Identifier)

PHRC IR 2018 DELABAERE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 596 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Multiple pregnancy
• Uterine scare

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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596 participants in 2 patient groups

free ultrasound propagation velocity

Experimental group

Description:

ultrasound exams will be performed using several ultrasound propagation velocities

Treatment:

Device: ultrasound propagation velocities, ultrasound fetal quality

conventional ultrasound propagation velocity

No Intervention group

Description:

ultrasound exams will be performed using the 1540m/s conventional celerity