| NCT ID | NCT04613583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aberdeen |
| Condition | Fetal Developmental Abnormality |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2016-05-01 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2016-05-01 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Paul A Fowler, PhD
PRINCIPAL INVESTIGATOR
University of Aberdeen
Frequently Asked Questions
Who can join the NCT04613583 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Fetal Developmental Abnormality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04613583 currently recruiting?
Yes, NCT04613583 is actively recruiting participants. Contact the research team at p.a.fowler@abdn.ac.uk for enrollment information.
Where is the NCT04613583 trial being conducted?
This trial is being conducted at Aberdeen, United Kingdom.
Who is sponsoring the NCT04613583 clinical trial?
NCT04613583 is sponsored by University of Aberdeen. The principal investigator is Paul A Fowler, PhD at University of Aberdeen. The trial plans to enroll 1,200 participants.