Trials / Recruiting
RecruitingNCT06523543
Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (estimated)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
Detailed description
During pregnancy, biological screening for genetic diseases of the fetus cannot be implemented before the 11th week of amenorrhea whatever the technique used. This delay is long and distressing, particularly for people at high risk of transmission of genetic diseases. The presence of extravillous trophoblast cells to the cervix of the pregnant woman from the 7th week, accessible by a cervicovaginal smear non-invasive, represents new biological material representative of the fetal genome. This project aimed at evaluating the performance of a method for analyzing these trophoblast cells extra-villous at the start of pregnancy. The investigators want to evaluate performance analytical aspects of this method, that is to say, verifying that the genetic information resulting from these cells correspond to those of the fetus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Inclusion (Visit 1 - Week 7-16) | Extraction of cervico-vaginal sampling |
| DIAGNOSTIC_TEST | Second semester of pregnancy (Visit 2 - Week 20-24) | Ultrasound examination (determination of chromosomal sex) |
| DIAGNOSTIC_TEST | Third semester of pregnancy (Visit 3- Week 34) | Ultrasound examination (determination of chromosomal sex) if this has not be done during the Visit 2 or if a new determination correcting the previous one is provided. |
Timeline
- Start date
- 2024-11-19
- Primary completion
- 2027-08-30
- Completion
- 2028-09-01
- First posted
- 2024-07-26
- Last updated
- 2026-03-13
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06523543. Inclusion in this directory is not an endorsement.