Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07286591

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

Led by Clinique Rive Gauche · Updated on 2026-03-17

50

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of artificial intelligence (AI) to assist in second-trimester pregnancy screening ultrasounds, which are critical for assessing fetal growth and identifying structural abnormalities. The study compares the quality of images captured manually by sonographers to those automatically acquired and validated by an AI system called Live View Assist. This research aims to determine if AI-assisted imaging can match the quality standards set by the French College of Fetal Ultrasound while potentially improving efficiency and standardization during routine obstetric monitoring. The study has two groups: one where sonographers manually acquire 22 mandatory and up to 4 additional ultrasound images following standardized protocols, and another where the Live View Assist system automatically captures 20 mandatory images and possibly 2 complementary ones in real time. This AI system recognizes and freezes required fetal views, automatically validating images according to reference standards, which may reduce operator variability and save time. Participants will undergo their routine second-trimester ultrasound between 20 and 24 weeks gestation. The study evaluates image quality based on acceptability criteria over an average period of six months. Researchers will assess whether the AI tool's images meet quality standards compared to manual acquisition. This includes examining feasibility, time efficiency, and impacts on sonographers' workload. Women involved will provide informed consent and be monitored under standard clinical conditions throughout their participation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 or over
  • Single, viable pregnancy confirmed by first-trimester ultrasound with no known malformations
  • Scheduled for routine second-trimester screening ultrasound between 20 weeks + 0 days and 24 weeks + 6 days
  • Provided informed consent
  • Affiliated with social security or beneficiary of such a plan
Not Eligible

You will not qualify if you...

  • Multiple pregnancy
  • Known fetal malformation
  • Pathological pregnancy
  • Cognitive impairment or difficulty understanding instructions or questionnaires
  • Under legal guardianship
  • Not covered by health insurance
  • Adult under legal protection or deprived of liberty by judicial or administrative decision

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants undergo a second-trimester pregnancy screening ultrasound using either standard manual acquisition or AI-assisted acquisition to capture required fetal images.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Clinique Rive Gauche

Toulouse, France, 31300

Actively Recruiting

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Research Team

J

Jean-Pierre Perrigaud

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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