Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-05

Study Completion Date

2024-10-05

Brief Summary

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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

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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.

Conditions

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Fetal Growth Retardation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

Blood samples

Intervention Type BIOLOGICAL

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

Interventions

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Blood samples

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No