Non-invasive testing for placental chromosome issues in growth-restricted fetuses
Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction
This study is testing a new way to check for chromosome problems in the placenta of babies who are not growing properly by using a simple blood test from their mothers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 3 sites (Bordeaux and 2 other locations) |
| Trial ID | NCT05023161 on ClinicalTrials.gov |
What this trial studies
This project aims to non-invasively detect chromosomal abnormalities in the placenta of fetuses diagnosed with intrauterine growth restriction (IUGR) below the 3rd percentile. The approach involves analyzing cell-free DNA from maternal blood samples using high-throughput whole genome sequencing. This method will run in parallel with amniocentesis to explore placental causes of fetal growth issues. The study is conducted at the DDIANE fetal medicine center at Bordeaux University Hospital and includes patients from multiple locations.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 18 years old with a fetus diagnosed with IUGR below the 3rd percentile who are willing to undergo amniocentesis.
Not a fit: Patients with non-isolated IUGR or those who do not consent to invasive prenatal diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more accurate method for diagnosing placental chromosomal abnormalities in growth-restricted fetuses.
How similar studies have performed: Other studies have shown promise in using non-invasive prenatal testing for detecting chromosomal abnormalities, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux and 2 other locations
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (Recruiting)
- Hôpital Antoine Béclère — Clamart, France (Not_yet_recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Caroline THAMBO
- Email: caroline.rooryck-thambo@chu-bordeaux.fr
- Phone: 05 56 79 59 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.