Single-center Prospective Descriptive Study Evaluating the Presence of Nanoparticles in the Amniotic Fluid in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Percentage of nanoparticles in amniotic fluid (%)
研究概览
简要总结
The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers. However, their impact on health remains little evaluated.
Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and toxicity in the fetus has been studied in many animals. The investigators seem interesting at first to establish the mineralogical load in the amniotic fluid in humans.
The first objective of this study is to determine the mineralogical NP load, quantity and composition, in the amniotic fluid in pregnant women.
详细描述
The analysis will be done on 100 amniotic fluid samples and 100 blood samples. Particle size analysis will be performed by a technique of dynamic light scattering, which permits the distribution by volume or by number of NP according to their size. Parallel to the different chemical species present in the sample must be measured by atomic emission spectrometry with inductively coupled plasma.
The results of this study will be useful for further studies on the fetal toxicity of NP in humans.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient major
- •Patient to receive an amniocentesis for medical reasons other than study (serum marker of the first quarter with an increased risk of trisomy 21 greater than 1/250, amniodrainage, sonographic sign of call)
- •Patient who have given their free, informed and signed
排除标准
- •Inability to make withdrawals
结局指标
主要结局
Percentage of nanoparticles in amniotic fluid (%)
时间窗: day 1
Percentage of each mineralogical Nanoparticle present in the amniotic fluid
次要结局
- Percentage of nanoparticles in blood(day 1)
- Correlation Nanoparticles between blood and amniotic fluid(day 1)