Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
- Conditions
- Pregnant Women
- Registration Number
- NCT06523543
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 25
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Establish an ultra-early detection method Visit 2 (Week 20-24) Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography
- Secondary Outcome Measures
Name Time Method Expected benefit of ultra-early cytogenetic information Visit 2 (Week 20-24) Evaluate the ability of the method to provide a rapid result and evaluate the impact of information about pregnant women
Evaluate the ability of the method to provide a result in the context of a progressive pregnancy Visit 2 (Week 20-24) * Time (minutes) elapsed between sampling and biological validation of the result
* Number of trophoblast cells identified
* Failure rate: number of samples for which biological signals were not successful to determine the fetal chromosomal sex
Related Research Topics
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Trial Locations
- Locations (1)
CHU de Montpellier
🇫🇷Montpellier, France
CHU de Montpellier🇫🇷Montpellier, FranceVincent GATINOIS, DrPrincipal Investigator