Scottish Advanced Fetal Research Study

NCT04613583 | Recruiting

• 1 other identifier: 2-051-15
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Developmental Abnormality; Fetal Development; Human; Life Style

Keywords

fetal; human; gestation; development; congenital; exposures; maternal; life style; exogenous chemicals; obesity; deprivation; alcohol; cigarette; endocrine disruption

Outcome Measures

Primary Outcomes (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.

  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.

  Whole project, up to 10 years

Secondary Outcomes (4)

• (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

• (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

• (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

Study Arms (1)

SAFeR Fetuses

Different maternal lifestyle factors: smoking, BMI, social deprivation, alcohol use, medicines. Depends on specific subproject analyses.

Other: SAFeR fetuses

Interventions

SAFeR fetuses OTHER

NO active intervention performed.

SAFeR Fetuses

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

RECRUITING

Related Publications (6)

• Vazakidou P, Evangelista S, Li T, Lecante LL, Rosenberg K, Koekkoek J, Salumets A, Velthut-Meikas A, Damdimopoulou P, Mazaud-Guittot S, Fowler PA, Leonards PEG, van Duursen MBM. The profile of steroid hormones in human fetal and adult ovaries. Reprod Biol Endocrinol. 2024 May 22;22(1):60. doi: 10.1186/s12958-024-01233-7.

  PMID: 38778396 RESULT

• Bongaerts E, Lecante LL, Bove H, Roeffaers MBJ, Ameloot M, Fowler PA, Nawrot TS. Maternal exposure to ambient black carbon particles and their presence in maternal and fetal circulation and organs: an analysis of two independent population-based observational studies. Lancet Planet Health. 2022 Oct;6(10):e804-e811. doi: 10.1016/S2542-5196(22)00200-5.

  PMID: 36208643 RESULT

• Mamsen LS, Zafeiri A, Botkjaer JA, Hardlei JR, Ernst E, Oxvig C, Fowler PA, Andersen CY. Expression of the Insulin-like Growth Factor System in First- and Second-Trimester Human Embryonic and Fetal Gonads. J Clin Endocrinol Metab. 2020 Sep 1;105(9):e3157-68. doi: 10.1210/clinem/dgaa470.

  PMID: 32726409 RESULT

• Walker N, Filis P, O'Shaughnessy PJ, Bellingham M, Fowler PA. Nutrient transporter expression in both the placenta and fetal liver are affected by maternal smoking. Placenta. 2019 Mar;78:10-17. doi: 10.1016/j.placenta.2019.02.010. Epub 2019 Feb 25.

  PMID: 30955705 RESULT

• O'Shaughnessy PJ, Antignac JP, Le Bizec B, Morvan ML, Svechnikov K, Soder O, Savchuk I, Monteiro A, Soffientini U, Johnston ZC, Bellingham M, Hough D, Walker N, Filis P, Fowler PA. Alternative (backdoor) androgen production and masculinization in the human fetus. PLoS Biol. 2019 Feb 14;17(2):e3000002. doi: 10.1371/journal.pbio.3000002. eCollection 2019 Feb.

  PMID: 30763313 RESULT

• Johnston ZC, Bellingham M, Filis P, Soffientini U, Hough D, Bhattacharya S, Simard M, Hammond GL, King P, O'Shaughnessy PJ, Fowler PA. The human fetal adrenal produces cortisol but no detectable aldosterone throughout the second trimester. BMC Med. 2018 Feb 12;16(1):23. doi: 10.1186/s12916-018-1009-7.

  PMID: 29429410 RESULT

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

MeSH Terms

Conditions

Congenital Abnormalities; Obesity

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul A Fowler, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul A Fowler, PhD

CONTACT

+44 1224 437528; p.a.fowler@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Institute of Medical Sciences

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: November 3, 2020
• Study Start: May 1, 2016
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

GB (1)