Pregnant Obese Women and Fetal Ultrasound Quality.

Pregnant Women Clinical Trial

— EPOWUS  

Official title:

Echography in Pregnant Obese Women and Ultrasound Speed.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212234
• Other study ID #: PHRC IR 2018 DELABAERE
• Secondary ID: 2018-A03478-47
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: September 2021

Study information

• Verified date: December 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: September 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Body mass index>30

• Between 20 and 25 weeks of gestation

Exclusion Criteria:

• Multiple pregnancy

• Uterine scare

Related Conditions & MeSH terms

• Obese Women
• Obesity
• Pregnant Women

Intervention

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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	image quality of fetal ultrasound exam	Quality will be assessed by calculating Salomon's score for each image.	second trimester and third trimester ultrasound exam
Primary	completeness of fetal 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.	second trimester and third trimester ultrasound exam
Secondary	use of supplementary ultrasound exams in order to assess completeness	description of each modality of supplemental ultrasound exam	through study completion, an average of 1 year
Secondary	description of ultrasonographist method in order to improve ultrasound exam	description of modality	through study completion, an average of 1 year
Secondary	economic analysis of the intervention	cost-effectiveness analysis	through study completion, an average of 1 year