Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction (DPNI-RCIU)

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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Growth Retardation
• Intervention / Treatment: Biological: Blood samples

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Caroline THAMBO; Phone Number: 05 56 79 59 52; Email: caroline.rooryck-thambo@chu-bordeaux.fr
• Study Contact Backup: Name: Virginie RACLET; Phone Number: 05 56 79 59 52; Email: virginie.raclet@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • Centre Hospitalier Universitaire de Bordeaux
    • Contact: Caroline THAMBO; Phone Number: 05 56 79 59 52; Email: caroline.rooryck-thambo@chu-bordeaux.fr
  • Clamart, France, 92140
    • Not yet recruiting
    • Hôpital Antoine Béclère
    • Contact: Alexandre VIVANTI, MD; Phone Number: +331.45.37.44.41; Email: alexandre.vivanti@aphp.fr
    • Principal Investigator: Alexandre VIVANTI, MD
  • Toulouse, France, 31059
    • Not yet recruiting
    • CHU Toulouse
    • Contact: Christophe VAYSSIERE, PROF; Phone Number: +335 67 77 12 16; Email: vayssiere.c@chu-toulouse.fr
    • Principal Investigator: Christophe VAYSSIERE, PROF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient having a fetus with intra-uterine growth restriction diagnosis below the 3rd percentile	Biological: Blood samples; Performed a 10 ml blood sample in each of the 200 patients included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Estimated): October 5, 2024
• Study Completion (Estimated): October 5, 2024

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: trisomy; Non Invasive Prenatal Testing; cell- free DNA; placenta confined mosaic
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Growth Retardation
• Other Study ID Numbers: CHUBX 2021/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No