Pregnant Obese Women and Fetal Ultrasound Quality.

NCT04212234 | Completed

• 2 other identifiers: PHRC IR 2018 DELABAERE2018-A03478-47
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 5

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.

Conditions

Obese Women; Pregnant Women

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• use of supplementary ultrasound exams in order to assess completeness

  through study completion, an average of 1 year

• description of ultrasonographist method in order to improve ultrasound exam

  through study completion, an average of 1 year

• economic analysis of the intervention

  through study completion, an average of 1 year

Study Arms (2)

free ultrasound propagation velocity

EXPERIMENTAL

ultrasound exams will be performed using several ultrasound propagation velocities

Device: ultrasound propagation velocities, ultrasound fetal quality

conventional ultrasound propagation velocity

NO INTERVENTION

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

Interventions

ultrasound propagation velocities, ultrasound fetal quality DEVICE

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.

free ultrasound propagation velocity

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Multiple pregnancy
• Uterine scare

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (5)

Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Hôpital de la Croix Rousse - Hospices Civils de Lyon

Lyon, France

Location

Hôpital Femme Mére Enfant - Hospices Civils de Lyon

Lyon, France

Location

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, France

Location

Hôpital Cochin - Assistance Publique - Hôpitaux de Paris

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 34548341 DERIVED

Study Officials

• Amélie Delabaere, MD, PhD

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: December 26, 2019
• Study Start: December 2, 2019
• Primary Completion: October 19, 2024
• Study Completion: October 19, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)