UPRISE Unravelling Ultrafine Particulate Matter and Micro Nano Plastic's Mechanisms of Impact on Fetal Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- PreTerm Birth
研究概览
简要总结
This project aims at unravelling mechanisms by which exposure to air pollution (in particular Ultrafine Particulate (UFP, PM0.1), and micro nano plastic's) interferes with the normal foetus development, with a short-term causal effect in higher likeliness of preterm delivery which, in consequence, precondition a higher likeliness to suffer non-communicable diseases (NCD) later in the life.
详细描述
The characteristics of this study population are as follows:
- Case-control design The study includes 1600 participants, providing a substantial sample for analysis. The focus is on newborns (age 0), making the study particularly relevant for understanding factors and outcomes related to this very early stage of life. The sex of the participants is expected to be randomly distributed. A control arm of full-term neonates (>37 weeks) will be recruited for a 1:2 ratio in Greece and Spain.
- Personal Exposure Monitoring PEM Substudy:
The study consists of 150 mothers, with 50 from each location. All participants are females aged over 18 years. The sex of the participants is expected to be randomly distributed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Agreement to sign the informed consent;
- •Non-smoking mothers and no exposure to environmental (second-hand) smoke (smoking influences UFP measurements);
- •≥18 years old (mothers have to place sensors, mothers with childhood pregnancies may live at their parental home);
- •Not expecting to terminate the pregnancy (no measurements of the child);
- •Having resided in the geographical area of research for a minimum period of 1 year (to be eligible for modeling exposures).
排除标准
- •First visit after 11 weeks of gestation (to ensure 2-week monitoring in the first trimester);
- •Pregnancy complications that limit exposure measurements in urine (because it may cause polyuria, for example, gestational diabetes);
- •Known kidney disease (might influence exposure measurements in urine);
- •Multiple pregnancy (twin or more pregnancies may have a higher risk for complications or preterm birth, no measurements in the last trimester).
结局指标
主要结局
PreTerm Birth
时间窗: at the moment of birth
Small for Gestational Age
时间窗: at the moment of birth
Low Birth Weigth
时间窗: at the moment of birth
次要结局
未报告次要终点
研究者
Alba Ruiz Gaitán
MD, PhD
Instituto de Investigacion Sanitaria La Fe