NCT Number: NCT01778205
The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.
The recent fall in birth and death rates has led to demographic changes such as low fertility and high life expectancy . The WHO reports the median age of the European population to be the highest in the world and predicts that the proportion of over-60s in will increase from 14% in 2010 to 25% in 2050. There is wide variability in the quality of health and well-being in the ageing population. Longevity with a good quality of life is a consequence of the combination of an individual's genes, nutrition, environment, lifestyle and medical interventions. There is increasing evidence that research into healthy ageing needs to start with early life data to capture all traits and exposures experienced by an individual throughout life. Epigenetic imprinting occurs both in utero and during early postnatal development. Maternal environmental exposures, including nutritional status, may have a permanent effect on the developing foetus by influencing epigenetic profiles and leading to life-long genome adaptation. Numerous reports show that restricted intra-uterine growth due to poor maternal nutrition during pregnancy increases risk in the offspring of developing mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. To understand the basic mechanisms and interactions through which the ageing phenotype develops, systems involved in key processes of early development must be considered as well as those crucial to health in older persons. The Reus and Tarragona Birth Cohort is a longitudinal study. In the first phase, blood is collected from pregnant women at <12, 15, 24-27 and 34 gestational weeks (GW) and at labor and from the cord. Detailed lifestyle, habits and supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at <12GW and at birth. Placental vascular function is assessed at 20 and 32 GW by analysis of Doppler waveforms of the uterine arteries. Data on pregnancy evolution and outcome are also recorded. The first phase investigates the association between gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy outcome. The second phase of the study follows up the children at 7.5 years of age. Growth, exercise and nutritional habits as well as environment and cognitive development are assessed. The aims are to investigate the association between gene-environment interactions associated with healthy development from early pregnancy until 7.5 years of age.
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Observational
Primary location
Hospital Universitari Sant Joan de Reus, Reus, Tarragona, Spain
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- <12 weeks pregnant at first prenatal check up
Exclusion criteria
- Illnesses / interventions affecting nutritional status, major recent surgery in the previous 6 months, multiple pregnancies
Treatment and study plan
Primary outcomes
-
Birth weight
Time frame: At birth
-
Doppler waveforms of uterine arteries
Time frame: 20 gestational weeks
Other outcomes
-
1-C metabolites
Time frame: <12, 15, 24-27, 34 gestational weeks, at labor, in the cord
-
Intrauterine growth retardation
Time frame: At birth
Sponsors and collaborators
Lead sponsor
Institut Investigacio Sanitaria Pere Virgili
Other
Collaborators
- European Regional Development Fund
- Instituto de Salud Carlos III
- Italfarmaco
- JPI ERA-HDHL
- State Research Agency, Spain
- University Rovira i Virgili
Registry information
Official study title
Phase 1 Study of the Effect of Maternal Nutritional Status on Placental Vascular Function, Fetal Growth and Intrauterine Growth Retardation.
Important dates
- Study start
- 2005
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Jan 29, 2013
- Registry last updated
- Sep 23, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.