About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Women exhibiting considerable emotional distress.
Fetal anomalies identified at ultrasound scan.
Trial population
Human fetuses and their placentas collected without incentive from elective medical termination of normally progressing pregnancies. Data from the mothers is included in analyses.
Trial design
Other
Other
Treatments tested in this trial
SAFeR fetuses
Other interventionNO active intervention performed.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
(1) The identification of key stages and regulators required for the normal development of the human fetus and its placenta.
(1) The identification of key stages and regulators required for the normal development of the human fetus and its placenta.
(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.
(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.
(3) Mechanistic insights into how fetal human development is controlled and how this control can be disturbed by maternal factors.
(3) Mechanistic insights into how fetal human development is controlled and how this control can be disturbed by maternal factors.
(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.
(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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aberdeen
Lead sponsor
NHS Grampian
Collaborator