Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

NCT05023161 | Unknown

• 1 other identifier: CHUBX 2021/12
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Fetal Growth Retardation

Keywords

Non Invasive Prenatal Testing; cell- free DNA; trisomy; placenta confined mosaic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine the proportion of chromosomal placental etiology in Intrauterine Growth Restriction.

  Inclusion date

Study Arms (1)

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

Biological: Blood samples

Interventions

Blood samples BIOLOGICAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound)
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (3)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

RECRUITING

Hôpital Antoine Béclère

Clamart, 92140, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, 31059, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood sample

MeSH Terms

Conditions

Fetal Growth Retardation; Trisomy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aneuploidy; Chromosome Aberrations; Chromosome Duplication

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Caroline THAMBO

CONTACT

05 56 79 59 52; caroline.rooryck-thambo@chu-bordeaux.fr

Virginie RACLET

CONTACT

05 56 79 59 52; virginie.raclet@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: October 5, 2021
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)