About this trial
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant woman
Singleton pregnancy
Pregnancy between 7 and 16 weeks of amenorrhea (WA)
Woman ≥ 18 years
Disqualifiers
None
Trial population
Pregnant women with a priori genetic risk
Trial design
Cohort
Prospective
Treatments tested in this trial
Inclusion (Visit 1 - Week 7-16)
Procedure/SurgeryExtraction of cervico-vaginal sampling
Second semester of pregnancy (Visit 2 - Week 20-24)
Diagnostic testUltrasound examination (determination of chromosomal sex)
Third semester of pregnancy (Visit 3- Week 34)
Diagnostic testUltrasound 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.
Treatment groups
Trial outcomes
Primary outcomes
Establish an ultra-early detection method
Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography
Secondary outcomes
Evaluate the ability of the method to provide a result in the context of a progressive pregnancy
* 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
Expected benefit of ultra-early cytogenetic information
Evaluate the ability of the method to provide a rapid result and evaluate the impact of information about pregnant women
Sponsors and contacts
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