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Scottish Advanced Fetal Research Study (SAFeR)

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ClinicalTrials.gov Identifier: NCT04613583
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
Paul A Fowler, University of Aberdeen

Brief Summary:

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.


Condition or disease Intervention/treatment
Fetal Developmental Abnormality Fetal Development Human Life Style Other: SAFeR fetuses

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Other
Official Title: Normal Development of the Human Fetus and the Influences and Mechanisms by Which That Development Occurs and is Perturbed
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025

Group/Cohort Intervention/treatment
SAFeR Fetuses
Different maternal lifestyle factors: smoking, BMI, social deprivation, alcohol use, medicines. Depends on specific subproject analyses.
Other: SAFeR fetuses
NO active intervention performed.




Primary Outcome Measures :
  1. 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. [ Time Frame: 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.


Secondary Outcome Measures :
  1. (1) The identification of key stages and regulators required for the normal development of the human fetus and its placenta. [ Time Frame: 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.

  2. (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. [ Time Frame: 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.

  3. (3) Mechanistic insights into how fetal human development is controlled and how this control can be disturbed by maternal factors. [ Time Frame: Whole project, up to 10 years ]
    (3) Mechanistic insights into how fetal human development is controlled and how this control can be disturbed by maternal factors.

  4. (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. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA

Human fetal blood and multiple organs (including brain, heart, lungs, liver, skin, joints, gonads, urogenital system, pancreas, thyroids, adrenals)

Placenta



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women exhibiting considerable emotional distress.
  • Fetal anomalies identified at ultrasound scan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613583


Contacts
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Contact: Paul A Fowler, PhD +44 1224 437528 p.a.fowler@abdn.ac.uk

Locations
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United Kingdom
University of Aberdeen Recruiting
Aberdeen, United Kingdom, AB25 2ZD
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Investigators
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Principal Investigator: Paul A Fowler, PhD University of Aberdeen
  Study Documents (Full-Text)

Documents provided by Paul A Fowler, University of Aberdeen:
Informed Consent Form  [PDF] December 15, 2015

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Responsible Party: Paul A Fowler, Director of the Institute of Medical Sciences, University of Aberdeen
ClinicalTrials.gov Identifier: NCT04613583    
Other Study ID Numbers: 2-051-15
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul A Fowler, University of Aberdeen:
fetal
human
gestation
development
congenital
exposures
maternal
life style
exogenous chemicals
obesity
deprivation
alcohol
cigarette
endocrine disruption
Additional relevant MeSH terms:
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Congenital Abnormalities