Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091, France
Location status: Recruiting
Location contact
Chris MINELLA, MD
CONTACT
Chris MINELLA, MD
PRINCIPAL_INVESTIGATOR
Lauren GUERIN, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07342933
Outcomes of Children in Whom a Prenatal Exome Was Performed Based on Ultrasound Findings
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?
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
0 year–3 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Strasbourg, France
Other
Registry information
Acronym: ExoPré
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 15, 2026
- Registry last updated
- Jan 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.