Outcomes of Children in Whom a Prenatal Exome Was Performed Based on Ultrasound Findings (ExoPré)

January 6, 2026 updated by: University Hospital, Strasbourg, France
Amniocentesis is a test offered to couples based on ultrasound findings during pregnancy. Currently, genetic analysis using FISH and ACPA is routinely performed. For the past four years, additional exome sequencing has been offered after two ultrasound findings, if FISH and ACPA are negative. In this study, investigators aim to review the results of this exome sequencing analysis, examine the outcomes obtained, and study the outcomes of the children after birth. Can parents be completely reassured when the exome sequencing is negative, or does this indicate that investigators are not yet sufficiently sensitive in their genetic analysis?

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

70

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 Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Chris MINELLA, MD
        • Principal Investigator:
          • Lauren GUERIN, MD

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Child under 4 years of age having an exome sequencing performed at the Strasbourg University Hospitals following amniocentesis during pregnancy between November 2021 and September 2025.

Description

Inclusion Criteria:

  • Child under 4 years of age
  • Exome sequencing performed at the Strasbourg University Hospitals (HUS) following amniocentesis during pregnancy between November 2021 and September 2025.

Exclusion Criteria:

  • Refusal to participate in the study
  • Exome sequencing not performed at the Strasbourg University Hospital.
  • Lack of prenatal ultrasound information.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychomotor development of the children
Time Frame: Up to 24 months

Psychomotor development of the children based on items from the health record:

The items in the child's health record are used to:

  • monitor the child's normal development,
  • detect any potential delays early, and
  • reassure parents or refer them to a professional if needed.

Example: If a child is not yet walking at 18 months:

  • this is not necessarily serious,
  • but it may lead the doctor to suggest monitoring or exercises.
Up to 24 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

July 22, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 22, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9815

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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