Non-invasive Prenatal Testing of Placental Chromosomal Abnormalities in Fetus With Intrauterine Growth Restriction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Determine the presence or absence of chromosomal abnormality in the plasma sample. studied.
研究概览
简要总结
The objective of this project is the non-invasive prenatal detection of placenta-limited aneuploidies, in patients whose fetuses have a intrauterine growth restriction below 3rd percentile, in parallel with an amniocentesis.
This study will allow the chromosomal study of the placenta in pregnant women whose genetic prenatal diagnosis, made by amniocentesis, does not allow exploring the placental causes of fetal RCIU.
详细描述
Placental chromosomal aneuploidies will be detected by high-throughput whole genome sequencing of non-cellular DNA present in maternal plasma during pregnancy.
The study of the cfDNA will be carried out from a blood sample with the automated solution VERISEQ NIPT (Illumina) using the software illumina VeriSeq v2, allowing the detection of all chromosomal abnormalities.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •over 18 years old,
- •treated in the DDIANE fetal medicine centre at the Bordeaux University Hospital,
- •having a fetus with IUGR diagnosis below the 3rd percentile (after reference medical ultrasound),
- •from 16 weeks of amenorrhea or more,
- •accepting an Invasive Prenatal Diagnosis by amniocentesis with array comparative genomic hybridization
排除标准
- •Childbearing women who:
- •do not accept a non-invasive prenatal diagnosis (amniocentesis)
- •have a fetus with non-isolated IUGR (associated with other ultrasound signs)
- •do not consent to participate in the research protocol
结局指标
主要结局
Determine the presence or absence of chromosomal abnormality in the plasma sample. studied.
时间窗: Inclusion date
The result will be expressed in presence or absence of chromosomal abnormality such as trisomy, monosomy, deletion or duplication. The result will be compared with the fetal chromosome analysis carried out concomitantly on liquid amniotic as part of the treatment: if the analysis on Liquid Amniotic shows the same anomaly, it means that it is a fetal abnormality, if the Liquid Amniotic test is normal, it means that it is most likely an abnormality placental chromosome.
次要结局
- Determine the proportion of chromosomal placental etiology in Intrauterine Growth Restriction.(Inclusion date)