Pregnant Obese Women and Fetal Ultrasound Quality.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2024-10-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ultrasound Assessment of Gastric Content in Fasted Pregnant Women

NCT04277013

Gastric Ultrasound Fasting ( 6H for Solid ; 2H for Clear Fluid ) Pregnant Women

UNKNOWN

Obese Pregnant Women: Optimizing Fetal Ultrasound

NCT02487641

Obesity Fetal Malformation

UNKNOWN

Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery

NCT05946447

Pregnancy Respiratory Aspiration of Gastric Content

COMPLETED NA

Developing and Testing AI Models for Fetal Biometry and Amniotic Volume Assessment in Fetal Ultrasound Scans.

NCT05059093

Small for Gestational Age Infant Fetal Growth Restriction Oligohydramnios +1 more

COMPLETED

Accuracy of 5D LB Ultrasound in Predicting Birth Weight of Preterm Fetuses : A Pilot Study

NCT02401438

Prematurity

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obese Women Pregnant Women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

free ultrasound propagation velocity

ultrasound exams will be performed using several ultrasound propagation velocities

Group Type EXPERIMENTAL

ultrasound propagation velocities, ultrasound fetal quality

Intervention Type 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.

conventional ultrasound propagation velocity

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE