An observational study in Pregnant Women, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by University Hospital, Montpellier · Observational
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
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.
University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women with a priori genetic risk
Exclusions Criteria:
Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
Procedure: Inclusion (Visit 1 - Week 7-16) · Diagnostic Test: Second semester of pregnancy (Visit 2 - Week 20-24) · Diagnostic Test: Third semester of pregnancy (Visit 3- Week 34)
Extraction of cervico-vaginal sampling
Ultrasound examination (determination of chromosomal sex)
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.
Establish an ultra-early detection method
Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography
Time frame: Visit 2 (Week 20-24)
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
Time frame: Visit 2 (Week 20-24)
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
Time frame: Visit 2 (Week 20-24)
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University Hospital, Montpellier