Isolated Intrauterine Growth Restriction (IUGR)RCIUNCT07864272
Assessment of Invasive Genetic Testing in Fetuses With Isolated Intrauterine Growth Restriction Diagnosed After 28 Weeks of Gestation at Strasbourg University Hospitals (2016-2023)
An observational study of Isolated Intrauterine Growth Restriction (IUGR), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study evaluates the diagnostic yield of invasive genetic testing in fetuses with isolated intrauterine growth restriction diagnosed after 28 weeks of gestation, in order to better define indications for invasive procedures and improve clinical counseling. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Isolated Intrauterine Growth Restriction (IUGR)
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2026to 12 Jan 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women managed at Strasbourg University Hospitals with isolated intrauterine growth restriction diagnosed after 28 weeks of gestation between 2016 and 2023.
Who may be able to join
- Maternal age ≥ 18 years
- Referral after 28 weeks of gestation for estimated fetal weight < 3rd percentile, isolated condition
- Management at Strasbourg University Hospitals between 01/01/2016 and 01/01/2023
- No documented opposition to reuse of medical data for research
Who cannot join
- Suspected fetal structural anomaly or infectious cause
- Multiple pregnancy
- Incomplete genetic workup
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 Gynécologie et Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091
Marie-Laure LEGRIS, MD, 33 3 88 12 73 02, marie-laure.legris@chru-strasbourg.fr
Marie-Laure LEGRIS, MD
About this study
Official title: Assessment of Invasive Genetic Testing Procedures in Fetuses With Isolated Intrauterine Growth Restriction (IUGR) Diagnosed After 28 Weeks of Gestation at Strasbourg University Hospitals Between 2016 and 2023
This study evaluates the diagnostic yield of invasive genetic testing in fetuses with isolated intrauterine growth restriction diagnosed after 28 weeks of gestation, in order to better define indications for invasive procedures and improve clinical counseling.
Read the detailed description
This is a retrospective monocentric study conducted at Strasbourg University Hospitals including all cases of isolated IUGR diagnosed after 28 weeks of gestation between 2016 and 2023. The study evaluates the proportion of invasive prenatal procedures performed, their diagnostic yield, and factors influencing both indication and performance of amniocentesis. Data are extracted from the DIAMM database and completed using DEFGEN for postnatal genetic results.
- Keywords
- IUGR, Amniocentesis, Fetal genetics
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of invasive genetic testing in isolated IUGR
Proportion of invasive prenatal procedures identifying a genetic abnormality explaining the intrauterine growth restriction
Measured: 2016-2023 retrospective period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start12 Jan 2026
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated Intrauterine Growth Restriction (IUGR)Studies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 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
- NCT07864272
- Sponsor's protocol ID
- RC25_0067
- Acronym
- RCIU
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Invasive Genetic Testing Procedures in Fetuses With Isolated Intrauterine Growth Restriction (IUGR) Diagnosed After 28 Weeks of Gestation at Strasbourg University Hospitals Between 2016 and 2023
- ClinicalTrials.gov ID
- NCT07864272
- Acronym / sponsor ID
- RCIU / RC25_0067
- Keywords
- IUGR, Amniocentesis, Fetal genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Jan 2027 (estimated)
- First posted
- 7 Oct 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.
This study evaluates the diagnostic yield of invasive genetic testing in fetuses with isolated intrauterine growth restriction diagnosed after 28 weeks of gestation, in order to better define indications for invasive procedures and improve clinical counseling.
Detailed description
This is a retrospective monocentric study conducted at Strasbourg University Hospitals including all cases of isolated IUGR diagnosed after 28 weeks of gestation between 2016 and 2023. The study evaluates the proportion of invasive prenatal procedures performed, their diagnostic yield, and factors influencing both indication and performance of amniocentesis. Data are extracted from the DIAMM database and completed using DEFGEN for postnatal genetic results.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women managed at Strasbourg University Hospitals with isolated intrauterine growth restriction diagnosed after 28 weeks of gestation between 2016 and 2023.
Key inclusion criteria (4 listed)
- Maternal age ≥ 18 years
- Referral after 28 weeks of gestation for estimated fetal weight < 3rd percentile, isolated condition
- Management at Strasbourg University Hospitals between 01/01/2016 and 01/01/2023
- No documented opposition to reuse of medical data for research
Key exclusion criteria (3 listed)
- Suspected fetal structural anomaly or infectious cause
- Multiple pregnancy
- Incomplete genetic workup
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
Diagnostic yield of invasive genetic testing in isolated IUGR
Time frame: 2016-2023 retrospective period
Proportion of invasive prenatal procedures identifying a genetic abnormality explaining the intrauterine growth restriction
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 7 Oct 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 Isolated Intrauterine Growth Restriction (IUGR), 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 4 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 7 Oct 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 Marie-Laure LEGRIS, MD (33 3 88 12 73 02, marie-laure.legris@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of invasive genetic testing in isolated IUGR (time frame: 2016-2023 retrospective period). 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 7 Oct 2026.