Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells (CellF-Cervix)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Pregnant Women

Treatments: Procedure: Inclusion (Visit 1 - Week 7-16); Diagnostic Test: Third semester of pregnancy (Visit 3- Week 34); Diagnostic Test: Second semester of pregnancy (Visit 2 - Week 20-24)

Study type: Observational

Funder types: Other

Identifiers

NCT06523543

RECHMPL23_0417

Details and patient eligibility

About

Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.

Full 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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

25 participants in 1 patient group

Pregnant women

Description:

Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)

Treatment:

Diagnostic Test: Second semester of pregnancy (Visit 2 - Week 20-24)

Diagnostic Test: Third semester of pregnancy (Visit 3- Week 34)

Procedure: Inclusion (Visit 1 - Week 7-16)