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Clinical Trials in France / NCT07342933
Recruiting Observational

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

NCT07342933 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Observational
Started
2025-07-22
Last updated
2026-01-15

Condition(s) studied

Amniocentesis Affecting Fetus

Study summary

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?

Eligibility

Sex
ALL
Min age
0 Years
Max age
3 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Psychomotor development of the children — 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.

Trial sites (1)

FacilityCityRegionStatus
Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France Strasbourg France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07342933 on ClinicalTrials.gov ↗ ← All trials in France