Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

Fetal Growth Retardation Clinical Trial

— DPNI-RCIU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023161
• Other study ID #: CHUBX 2021/12
• Status: Recruiting
• Start date: October 5, 2021
• Est. completion date: October 5, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Bordeaux
• Contact: Caroline THAMBO
• Phone: 05 56 79 59 52
• Email: caroline.rooryck-thambo[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 5, 2024
• Est. primary completion date: October 5, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Hôpital Antoine Béclère	Clamart
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Inclusion date
Secondary	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)	Inclusion date