Fetal Growth RetardationDPNI-RCIUNCT05023161
Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction
An observational study of Fetal Growth Retardation, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Blood samples
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- 5 Oct 2021to 5 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patient having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)
Who may be able to join
- over 18 years old,
- treated in the DDIANE fetal medicine centre at the Bordeaux University Hospital,
- having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound),
- from 16 weeks of amenorrhea or more,
- accepting an Invasive Prenatal Diagnosis by amniocentesis with array comparative genomic hybridization
Who cannot join
- Childbearing women who:
- do not accept a non-invasive prenatal diagnosis (amniocentesis)
- have a fetus with non-isolated IUGR (associated with other ultrasound signs)
- do not consent to participate in the research protocol
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Centre Hospitalier Universitaire de Bordeaux
Bordeaux
Caroline THAMBO, 05 56 79 59 52, caroline.rooryck-thambo@chu-bordeaux.fr
- Not yet recruiting
Hôpital Antoine Béclère
Clamart, 92140
Alexandre VIVANTI, MD, +331.45.37.44.41, alexandre.vivanti@aphp.fr
Alexandre VIVANTI, MD
- Not yet recruiting
CHU Toulouse
Toulouse, 31059
Christophe VAYSSIERE, PROF, +335 67 77 12 16, vayssiere.c@chu-toulouse.fr
Christophe VAYSSIERE, PROF
About this study
Official title: Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction
The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.
This study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.
Read the detailed description
Placental chromosomal aneuploidies will be detected by high-throughput whole genome sequencing of non-cellular DNA present in maternal plasma during pregnancy.
The study of the cfDNA will be carried out from a blood sample with the automated solution VERISEQ NIPT (Illumina) using the software illumina VeriSeq v2, allowing the detection of all chromosomal abnormalities.
- Conditions
- Fetal Growth Retardation
- Being tested
- Blood samples
- Keywords
- Non Invasive Prenatal Testing, cell- free DNA, trisomy, placenta confined mosaic
- Medical subject headings
- Fetal Growth Retardation, Trisomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Performed a 10 ml blood sample in each of the 200 patients included.
| Study group | Role | What they receive |
|---|---|---|
| Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile | Not described Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the presence or absence of chromosomal abnormality in the plasma sample. studied.
The result will be expressed in presence or absence of chromosomal abnormality such as trisomy, monosomy, deletion or duplication. The result will be compared with the fetal chromosome analysis carried out concomitantly on liquid amniotic as part of the treatment: if the analysis on Liquid Amniotic shows the same anomaly, it means that it is a fetal abnormality, if the Liquid Amniotic test is normal, it means that it is most likely an abnormality placental chromosome.
Measured: Inclusion date
Secondary outcomes (1)
Determine the proportion of chromosomal placental etiology in Intrauterine Growth Restriction.
Proportion will be described in terms of percentage counts and 95% confidence interval depending on the test Fisher's exact (p <0.05)
Measured: Inclusion date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start5 Oct 2021
- Primary completion5 Oct 2024 (estimated)
- Study completion5 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023161
- Sponsor's protocol ID
- CHUBX 2021/12
- Acronym
- DPNI-RCIU
- Status last verified
- Nov 2023
- First submitted
- 20 Aug 2021
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT05023161
- Acronym / sponsor ID
- DPNI-RCIU / CHUBX 2021/12
- Conditions
- Fetal Growth Retardation
- Keywords
- Non Invasive Prenatal Testing, cell- free DNA, trisomy, placenta confined mosaic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 5 Oct 2024 (estimated)
- Study completion
- 5 Oct 2024 (estimated)
- First posted
- 26 Aug 2021 (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.
The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.
This study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.
Detailed description
Placental chromosomal aneuploidies will be detected by high-throughput whole genome sequencing of non-cellular DNA present in maternal plasma during pregnancy.
The study of the cfDNA will be carried out from a blood sample with the automated solution VERISEQ NIPT (Illumina) using the software illumina VeriSeq v2, allowing the detection of all chromosomal abnormalities.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile | – | Biological: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patient having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)
Key inclusion criteria (5 listed)
- over 18 years old,
- treated in the DDIANE fetal medicine centre at the Bordeaux University Hospital,
- having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound),
- from 16 weeks of amenorrhea or more,
- accepting an Invasive Prenatal Diagnosis by amniocentesis with array comparative genomic hybridization
Key exclusion criteria (4 listed)
- do not accept a non-invasive prenatal diagnosis (amniocentesis)
- have a fetus with non-isolated IUGR (associated with other ultrasound signs)
- do not consent to participate in the research protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesPerformed a 10 ml blood sample in each of the 200 patients included. | Biological | Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile |
Primary outcome
Determine the presence or absence of chromosomal abnormality in the plasma sample. studied.
Time frame: Inclusion date
The result will be expressed in presence or absence of chromosomal abnormality such as trisomy, monosomy, deletion or duplication. The result will be compared with the fetal chromosome analysis carried out concomitantly on liquid amniotic as part of the treatment: if the analysis on Liquid Amniotic shows the same anomaly, it means that it is a fetal abnormality, if the Liquid Amniotic test is normal, it means that it is most likely an abnormality placental chromosome.
1 secondary outcome
Determine the proportion of chromosomal placental etiology in Intrauterine Growth Restriction.
Time frame: Inclusion date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation, run by University Hospital, Bordeaux at 3 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline THAMBO (05 56 79 59 52, caroline.rooryck-thambo@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the presence or absence of chromosomal abnormality in the plasma sample. studied. (time frame: Inclusion date). 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 8 Nov 2023.