Study Comparing Two Image Acquisition Modalities for Second-trimester Pregnancy Screening Ultrasound (Echo-IA) (Echo-IA)

March 16, 2026 updated by: Clinique Rive Gauche

A Single-center Cross-sectional Study Comparing Two Image Acquisition Modalities for Second-trimester Pregnancy Screening Ultrasound.

The second-trimester morphology ultrasound is a key examination in obstetric monitoring that aims to assess fetal growth, identify any structural abnormalities, and inspect anexes such as placenta, umbilical cord, cervix,...

Several studies suggest that a significant proportion of fetal malformations can be detected during this time frame if a complete morphological analysis is performed. However, the reliability of the screening depends on the quality of the equipment, the operator's level of expertise, and adherence to protocols that define the necessary scans.

In France, since the first reports of the National Technical Committee on Prenatal Screening Ultrasound (2005), particular attention has been paid to standardizing practices. More recently, the French National Conference on Obstetric and Fetal Ultrasound (CNEOF) published new recommendations (2022, revised in 2023) including the development of reference silhouettes for the second-trimester examination, proposing 26 views (22 required and 4 additional). However, the CNEOF does not formalize quality criteria for evaluating the conformity of these images; this task has been taken over by the French College of Fetal Ultrasound (CFEF), which has established a scoring and validation grid for each fetal slice (see CFEF 2022 document).

In parallel, artificial intelligence (AI) is gradually becoming established as a decision support and automation tool in medical imaging, particularly in ultrasound. Deep learning algorithms are capable of identifying anatomical structures, positioning measurement markers, and selecting the most optimal slice, reducing inter-operator variability and streamlining workflow. In the field of obstetric ultrasound, some companies have launched systems capable of detecting or annotating fetal structures in real time, potentially improving diagnostic reliability and reproducibility. Samsung has developed a system called Live View Assist, available on its latest generation ultrasound scanners, which uses AI to automatically recognize and freeze the required fetal slices in real time.

The tool also offers automated validation: if the detected slice conforms to the expected standards, it is directly checked off on a checklist. This innovation promises time savings, a reduced risk of missing certain complex slices, and improved standardization.

However, there is little data, particularly in France, regarding to the actual performance of this tool in a routine screening context. Before considering the integration of Live View Assist and AI into daily practice, it is therefore essential to evaluate the quality of the images it acquires, the feasibility of a complete examination assisted by AI, as well as the potential impact on examination time and improvement of the workload for sonographers.

The aim of this study is to evaluate whether the quality of the 20 mandatory images automatically validated by Live View Assist is not inferior to that of the 20 mandatory images acquired and validated manually by an ultrasound technician, according to the CFEF quality criteria based on the silhouettes recommended by the CNEOF.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France, 31300
        • Recruiting
        • Clinique Rive Gauche
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 18 or over,
  • With a single, viable pregnancy, definitively dated by first-trimester ultrasound, with no known malformations,
  • Scheduled for a routine second-trimester screening ultrasound, i.e., between 20 weeks + 0 days and 24 weeks + 6 days,
  • Having given their informed consent,
  • Affiliated with the social security system or a beneficiary of such a plan.

Exclusion Criteria:

  • Multiple pregnancy,
  • Known fetal malformation,
  • Pathological pregnancy,
  • Cognitive impairment, or a disorder causing difficulty understanding instructions or answering questionnaires,
  • Patient under legal guardianship,
  • Patient not covered by health insurance,
  • Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard ultrasound
Manual acquisition: acquisition of the 22 mandatory images and, if possible, the 4 additional images by the sonographer, respecting the standardized procedure derived from the CNEOF recommendations.
Procedure: Standard Ultrasound
Standard US with a sonographer
Experimental: Artificial intelligence-assisted ultrasound
AI-assisted acquisition: using the Live View Assist system to automatically capture the 20 mandatory views in real time, with validation and recording of images as soon as the algorithm detects an image conforming to the reference, and if possible the 2 complementary images.
Procedure: US with AI
US with Live View Assist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Images deemed "acceptable"
Time Frame: through study completion, an average of 6 months

Images deemed acceptable (i.e., for each image, all criteria are rated as good or acceptable, with none being insufficient or poor).

To evaluate the primary objective, the statistical unit will be the image. All 20 mandatory images for each patient will be analyzed
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinique Rive Gauche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Echo-IA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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