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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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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitari Sant Joan de Reus, Reus, Tarragona, Spain

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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

Observational

Other

Primary outcomes

  1. Birth weight

    Time frame: At birth

  2. Doppler waveforms of uterine arteries

    Time frame: 20 gestational weeks

Other outcomes

  1. 1-C metabolites

    Time frame: <12, 15, 24-27, 34 gestational weeks, at labor, in the cord

  2. 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.

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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.