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Completed

NCT Number: NCT04212234

Pregnant Obese Women and Fetal Ultrasound Quality.

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.

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Key information

Conditions

Obese Women Pregnant Women

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Multiple pregnancy
  • Uterine scare

Treatment and study plan

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.

Primary outcomes

  1. image quality of fetal ultrasound exam

    Time frame: second trimester and third trimester ultrasound exam

    Quality will be assessed by calculating Salomon's score for each image.

  2. completeness of fetal ultrasound exam

    Time frame: 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 outcomes

  1. use of supplementary ultrasound exams in order to assess completeness

    Time frame: through study completion, an average of 1 year

    description of each modality of supplemental ultrasound exam

  2. description of ultrasonographist method in order to improve ultrasound exam

    Time frame: through study completion, an average of 1 year

    description of modality

  3. economic analysis of the intervention

    Time frame: through study completion, an average of 1 year

    cost-effectiveness analysis

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Echography in Pregnant Obese Women and Ultrasound Speed.

Acronym: EPOWUS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2019
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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