Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
Overview
- Phase
- Not Applicable
- Intervention
- Third semester of pregnancy (Visit 3- Week 34)
- Conditions
- Pregnant Women
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Establish an ultra-early detection method
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Pregnant women
Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
Intervention: Third semester of pregnancy (Visit 3- Week 34)
Pregnant women
Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
Intervention: Inclusion (Visit 1 - Week 7-16)
Pregnant women
Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
Intervention: Second semester of pregnancy (Visit 2 - Week 20-24)
Outcomes
Primary Outcomes
Establish an ultra-early detection method
Time Frame: Visit 2 (Week 20-24)
Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography
Secondary Outcomes
- Expected benefit of ultra-early cytogenetic information(Visit 2 (Week 20-24))
- Evaluate the ability of the method to provide a result in the context of a progressive pregnancy(Visit 2 (Week 20-24))