Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

NCT05023161 — Unknown, 300 participants, University Hospital, Bordeaux

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Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction

Registry	NCT05023161, acronym DPNI-RCIU
Status	Unknown
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	University Hospital, Bordeaux (Other)
Conditions	Fetal Growth Retardation
Interventions	Blood samples (Biological)
Dates	start 2021-10-05, primary completion 2024-10-05 (estimated), completion 2024-10-05 (estimated), first posted 2021-08-26, last updated 2023-11-08
Locations	3 sites in France

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile		Biological: Blood samples

Blood samples (Biological): Performed a 10 ml blood sample in each of the 200 patients included.

+Outcome measures

Primary outcomes

Determine the presence or absence of chromosomal abnormality in the plasma sample. studied. [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.

Secondary outcomes

Determine the proportion of chromosomal placental etiology in Intrauterine Growth Restriction. [Inclusion date]: Proportion will be described in terms of percentage counts and 95% confidence interval depending on the test Fisher's exact (p <0.05)

+Eligibility

Sex: Female, ages: 18 Years to any

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:

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

+Locations (3)

Facility	City	Country	Status
Centre Hospitalier Universitaire de Bordeaux	Bordeaux	France	Recruiting
Hôpital Antoine Béclère	Clamart	France	Not yet recruiting
CHU Toulouse	Toulouse	France	Not yet recruiting