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The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.

Phase 1 Study of the Effect of Maternal Nutritional Status on Placental Vascular Function, Fetal Growth and Intrauterine Growth Retardation.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01778205
Enrollment
831
Registered
2013-01-29
Start date
2005-01-31
Completion date
2020-09-14
Last updated
2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Development

Brief summary

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.

Interventions

OTHERObservational

Sponsors

Italfarmaco
CollaboratorINDUSTRY
Instituto de Salud Carlos III
CollaboratorOTHER_GOV
State Research Agency, Spain
CollaboratorOTHER_GOV
JPI ERA-HDHL
CollaboratorUNKNOWN
University Rovira i Virgili
CollaboratorOTHER
European Regional Development Fund
CollaboratorOTHER
Institut Investigacio Sanitaria Pere Virgili
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Birth weightAt birth
Doppler waveforms of uterine arteries20 gestational weeks

Other

MeasureTime frame
1-C metabolites<12, 15, 24-27, 34 gestational weeks, at labor, in the cord
Intrauterine growth retardationAt birth

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026