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Status unknownNCT05023161DPNI-RCIUUpdated Nov 8, 2023

Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

An observational study in Fetal Growth Retardation, sponsored by University Hospital, Bordeaux. Status unknown at 3 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-08.

Sponsored by University Hospital, Bordeaux · Observational

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Fetal Growth Retardation

Keywords

  • Non Invasive Prenatal Testing
  • cell- free DNA
  • trisomy
  • placenta confined mosaic
03

In context

Fetal Growth Retardation

268 studies on the registry are indexed under Fetal Growth Retardation; 67 are open to participants now.

This study's planned enrollment of 300 is above the median of 164 across 144 observational studies indexed under Fetal Growth Retardation.

Browse Fetal Growth Retardation studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.

Browse University Hospital, Bordeaux studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patient having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile

    Biological: Blood samples

Interventions

  • BiologicalBlood samples

    Performed a 10 ml blood sample in each of the 200 patients included.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

    Time frame: Inclusion date

07

Study locations

1 of 3 sites recruiting
  • Centre Hospitalier Universitaire de Bordeaux
    Bordeaux, France
    Recruiting
  • Hôpital Antoine Béclère
    Clamart, 92140, France
    • Alexandre VIVANTI, MD · Contact · alexandre.vivanti@aphp.fr · +331.45.37.44.41
    • Alexandre VIVANTI, MD · Principal investigator
    Not yet recruiting
  • CHU Toulouse
    Toulouse, 31059, France
    • Christophe VAYSSIERE, PROF · Contact · vayssiere.c@chu-toulouse.fr · +335 67 77 12 16
    • Christophe VAYSSIERE, PROF · Principal investigator
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Oct 2024, 36 months after the start.

Of 69 non-industry observational studies under Fetal Growth Retardation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 69. This study's planned 36 months is close to that.

Counting every sponsor, half of 70 studies reached it within 35 months; a quarter within 22 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2021
First posted
Aug 26, 2021
StartActual
Oct 5, 2021
Primary completionEst.
Oct 5, 2024
CompletionEst.
Oct 5, 2024
Last update
Nov 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05023161
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Aug 26, 2021
Start date
Oct 5, 2021
Primary completion
Oct 5, 2024 (estimated)
Completion
Oct 5, 2024 (estimated)
Last update
Nov 8, 2023

Study contacts

Caroline THAMBO
Contact
caroline.rooryck-thambo@chu-bordeaux.fr
05 56 79 59 52
Virginie RACLET
Contact
virginie.raclet@chu-bordeaux.fr
05 56 79 59 52

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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