Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

Recruiting

• Conditions: Fetal Growth Retardation

• Registration Number: NCT05023161
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

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 Timeline

• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Study Start: 2021-10-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08
• Primary Completion: 2024-10-05
• Study Completion: 2024-10-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

CHU Toulouse; 🇫🇷 Toulouse, France