Early detection of fetal chromosomal characteristics using non-invasive methods
Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
This study is testing a new way to check for genetic issues in babies as early as the 7th week of pregnancy by using cells from the cervix of pregnant women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, France) |
| Trial ID | NCT06523543 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a novel non-invasive prenatal diagnostic method that utilizes extravillous trophoblast cells obtained from the cervix of pregnant women as early as the 7th week of pregnancy. By analyzing these cells, the researchers seek to identify fetal chromosomal abnormalities and genetic diseases much earlier than current methods allow, which typically start at the 11th week of amenorrhea. The study will involve multiple visits throughout the pregnancy to assess the effectiveness and accuracy of this approach. The goal is to provide timely and accurate genetic information to expectant mothers, particularly those at high risk for genetic disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with a singleton pregnancy between 7 and 16 weeks of amenorrhea who are at least 18 years old and can provide informed consent.
Not a fit: Patients who are under guardianship or legal protection, or those unable to provide informed consent, will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly reduce the anxiety and waiting time for pregnant women at risk of genetic diseases by providing early and accurate prenatal diagnostics.
How similar studies have performed: While the approach of using extravillous trophoblast cells for early genetic screening is innovative, similar non-invasive prenatal testing methods have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant woman * Singleton pregnancy * Pregnancy between 7 and 16 weeks of amenorrhea (WA) * Woman ≥ 18 years * Woman who has signed an informed consent * Woman affiliated to social security or equivalent scheme Exclusions Criteria: * Person under guardianship or curatorship * Person placed under legal protection * Person unable to provide the participant with informed consent.
Where this trial is running
Montpellier, France
- CHU de Montpellier — Montpellier, France, France (Recruiting)
Study contacts
- Principal investigator: Vincent GATINOIS, MD — University Hospital, Montpellier
- Study coordinator: Vincent GATINOIS, MD
- Email: v-gatinois@chu-montpellier.fr
- Phone: 0 67 33 68 66
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.