Amniocentesis Affecting FetusExoPréNCT07342933
Outcomes of Children in Whom a Prenatal Exome Was Performed Based on Ultrasound Findings
An observational study of Amniocentesis Affecting Fetus, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Amniocentesis Affecting Fetus
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2025to 22 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Refusal to participate in the study
- Exome sequencing not performed at the Strasbourg University Hospital.
- Lack of prenatal ultrasound information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Gynécologique et d'Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091
Chris MINELLA, MD, 33 3 88 12 74 95, chris.minella@chru-strasbourg.fr
Chris MINELLA, MD
About this study
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?
- Conditions
- Amniocentesis Affecting Fetus
- Keywords
- Amniocentesis Affecting Fetus, Prenatal Exome, Ultrasound Findings
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor development of the children
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start22 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completion22 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniocentesis Affecting FetusStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342933
- Sponsor's protocol ID
- 9815
- Acronym
- ExoPré
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Children in Whom a Prenatal Exome Was Performed Based on Ultrasound Findings
- ClinicalTrials.gov ID
- NCT07342933
- Acronym / sponsor ID
- ExoPré / 9815
- Conditions
- Amniocentesis Affecting Fetus
- Keywords
- Amniocentesis Affecting Fetus, Prenatal Exome, Ultrasound Findings
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- 22 Jul 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Exome sequencing not performed at the Strasbourg University Hospital.
- Lack of prenatal ultrasound information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amniocentesis Affecting Fetus, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris MINELLA, MD (33 3 88 12 74 95, chris.minella@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor development of the children (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.