Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Establish an ultra-early detection method
研究概览
简要总结
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Pregnant women
Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
干预措施: Third semester of pregnancy (Visit 3- Week 34) (Diagnostic Test)
Pregnant women
Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
干预措施: Inclusion (Visit 1 - Week 7-16) (Procedure)
Pregnant women
Women who are pregnant between 7 and 16 weeks of amenorrhea (WA)
干预措施: Second semester of pregnancy (Visit 2 - Week 20-24) (Diagnostic Test)
结局指标
主要结局
Establish an ultra-early detection method
时间窗: Visit 2 (Week 20-24)
Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography
次要结局
- 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))