Normal Development of the Human Fetus and the Influences and Mechanisms by Which That Development Occurs and is Perturbed
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- The provision of an extensive dataset on the human fetus during normal pregnancy and pregnancies where aspects of maternal lifestyle and environment will challenge the fetus, informing on future heath and function.
研究概览
简要总结
In-utero exposure to drugs and chemicals through maternal smoking, alcohol use, drug abuse, prescription medicines and occupational/lifestyle exposures is widespread. Such exposures can alter fetal development and programming, leading to the effects becoming "locked in" from birth and causing long-term adverse consequences for the individual. These include costly and widespread conditions such as obesity, hypertension, metabolic syndrome and infertility. The weight of evidence linking these conditions to fetal recreational drug or environmental chemical exposures, including cigarettes, alcohol, air pollution, food contact materials, is overwhelming. What is lacking is an understanding of how fetal drug exposure translates to adult ill-health and this is due, largely, to an inability to study the problem directly in affected human fetuses. The investigators, and others, have shown that human fetal development, which lays the foundations of adult health and function (fetal programming), is quite different from the rodent and frequently exhibits surprising aspects. It has become evident that the close interconnectivity of the developing fetal organs and also the placenta, means that a much more holistic approach to research aiming to understand human fetal development and the challenges posed to programming for a health adulthood is critical. To that end the investigators have established a carefully considered gestational age range (7-20 weeks of gestation) of fetuses we can study together with multiple fetal organs and body fluids collected and maternal information recorded.
The overarching objective of the study is to intensively and systematically study the human fetus during a normal pregnancy and pregnancies where aspects of maternal lifestyle and environment will challenge the fetus. The investigators aim to provide fundamental information to better understand the mechanisms involved and to detect and treat or ameliorate adverse effects during pregnancy (such as maternal smoking/drinking, deprivation, exposure to pollution). In the long term findings from this research will be important for future studies aimed at enabling better health in later life.
详细描述
Primary Objective
To provide fundamental information to better understand the mechanisms involved and to detect and treat or ameliorate adverse effects during pregnancy.
Secondary Objectives
The secondary objectives of this study are aimed at better understanding of normal processes during development and how maternal lifestyle and environment can affect it. The investigators' research will involve a wide range of laboratory, cell and tissue culture and xenografting as well as microscopic techniques to study chemicals, hormones, proteins, genes and DNA in the fetal tissues. The investigators have developed sophisticated approaches to minimise how much tissue is required to carry out as many different measurements as possible in the same sample. It should be noted that the proposed studies are collaborative with different research groups since no single research group could carry out all the studies in isolation. Furthermore, the proposed studies will inform back to animal and cell studies, enabling more accurate interpretation of their own findings in light of mechanisms and specific conditions actually at play in the human fetus.
- Human fetal endocrine system
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women at 7-20 weeks of gestation (critical stage of fetal development).
- •Women aged 16 years and older, deemed capable of making a rational decision.
- •Absence of fetal anomaly at ultrasound scan (only normal fetuses are required).
- •Women who are fluent English speakers. This is in order to ensure the woman understands that fetal tissues will be collected.
排除标准
- •Women exhibiting considerable emotional distress.
- •Fetal anomalies identified at ultrasound scan.
结局指标
主要结局
The provision of an extensive dataset on the human fetus during normal pregnancy and pregnancies where aspects of maternal lifestyle and environment will challenge the fetus, informing on future heath and function.
时间窗: Whole project, up to 10 years
The provision of an extensive dataset on the human fetus during normal pregnancy and pregnancies where aspects of maternal lifestyle and environment will challenge the fetus, informing on future heath and function.
次要结局
- (3) Mechanistic insights into how fetal human development is controlled and how this control can be disturbed by maternal factors.(Whole project, up to 10 years)
- (1) The identification of key stages and regulators required for the normal development of the human fetus and its placenta.(Whole project, up to 10 years)
- (2) The quantification of maternal lifestyle factors, including body burdens of toxicant chemicals (e.g. from smoking, from air pollution, from food contact material) and determination of their relationship with adverse fetal and placental outcomes.(Whole project, up to 10 years)
- (4) Establishment of the risks of adverse in-utero environment for future generations. This is epigenetic and focuses on ways in which fetal event, without any changes in genes themselves, can mis-programme the development of future generations.(Whole project, up to 10 years)
研究者
Paul A Fowler
Director of the Institute of Medical Sciences
University of Aberdeen
