Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition

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

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2023-03-17

Brief Summary

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

In the proposed clinical investigation, the investigational device (BabySize3D) will provide automated plane extraction and automated biometry measurements from 3D US volumes. The results obtained from the investigational software

Related Clinical Trials

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

Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

NCT03541291

Congenital Heart Disease

COMPLETED NA

Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

NCT00246766

Pregnancy Fetal Distress

UNKNOWN

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

The 3-Dimensional Ultrasound for Fetal Anomaly Scan

NCT00966537

Pregnancy

UNKNOWN

Fetal Anatomy by Three-Dimensional Ultrasound

NCT00340002

Preterm Birth Pregnancy Fetal Growth Abnormalities

COMPLETED

Detailed Description

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

Conditions

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

Pregnancy Related

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Main study: 3D volumes acquisitions

3D volume acquisitions

Group Type EXPERIMENTAL

3D volume acquisitions

Intervention Type DEVICE

2 abdominal volumes 2 thigh volumes 2 head volumes

Ancillary study: 2D and 3D acquisitions

2D standard measurements and 3D volumes acquisitions

Group Type EXPERIMENTAL

2D standard measurements and 3D volumes acquisitions

Intervention Type DEVICE

* 1 abdomen circumference measurement
* 1 femur length measurement
* 1 head circumference measurement
* 1 bi-parietal diameter measurement
* 1 abdominal volume
* 1 thigh volume
* 1 head volume

Interventions

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

3D volume acquisitions

2 abdominal volumes 2 thigh volumes 2 head volumes

Intervention Type DEVICE

2D standard measurements and 3D volumes acquisitions

* 1 abdomen circumference measurement
* 1 femur length measurement
* 1 head circumference measurement
* 1 bi-parietal diameter measurement
* 1 abdominal volume
* 1 thigh volume
* 1 head volume

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* evolutive pregnancy with one fetus with a Gestational Age between 16 and 30 weeks
* aged between 18 and 65 years.
* social welfare benefit recipient
* willing and able to provide informed consent

Exclusion Criteria

* under 18 years old
* multiple pregnancy
* over 18 years old and mentioned in French law articles L.1126-6 et L-1126-8,
* fetal malformation or suspected fetal malformation
* technical conditions that do not allow for standard fetal biometry (abdominal wall, fetal position, BMI \> 25 kg/m2)
* fetal biometry non indicated in the standard pregnancy follow-up
* unwilling or unable to provide informed consent (e. g. physical, mental disability or linguistic factor that compromises patient information)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes