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

NCT01778205 | Completed DMC

• 6 other identifiers: IISPV_Murphy1SPAIN MICINNSPAIN ISCIIISPAIN URVSPAIN AEIHorizon 2020
• Study Type: observational
• Target: 831
• Locations: 1 country
• Sites: 2

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.

Conditions

Intrauterine Development

Outcome Measures

Primary Outcomes (2)

• Birth weight

  At birth

• Doppler waveforms of uterine arteries

  20 gestational weeks

Other Outcomes (2)

• 1-C metabolites

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

• Intrauterine growth retardation

  At birth

Study Arms (1)

Pregnant women

Pregnant women with confirmed viable fetus at first prenatal check-up at \<12 gestational weeks

Other: Observational

Interventions

Observational OTHER

Pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women less than 12 weeks pregnant at their first pre-natal check up are recruited from the URV University Hospitals: Sant Joan (Reus) and Joan XXIII (Tarragona)

You may qualify if:

• \<12 weeks pregnant at first prenatal check up

You may not qualify if:

• Illnesses / interventions affecting nutritional status, major recent surgery in the previous 6 months, multiple pregnancies

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead
• Italfarmaco: collaborator
• Instituto de Salud Carlos III: collaborator
• State Research Agency, Spain: collaborator
• JPI ERA-HDHL: collaborator
• University Rovira i Virgili: collaborator
• European Regional Development Fund: collaborator

Study Sites (2)

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43201, Spain

Location

Hospital de Tarragona Joan XXIII

Tarragona, 43005, Spain

Location

Related Publications (6)

• Colomina JM, Cavalle-Busquets P, Fernandez-Roig S, Sole-Navais P, Fernandez-Ballart JD, Ballesteros M, Ueland PM, Meyer K, Murphy MM. Maternal Folate Status and the BHMT c.716G>A Polymorphism Affect the Betaine Dimethylglycine Pathway during Pregnancy. Nutrients. 2016 Oct 9;8(10):621. doi: 10.3390/nu8100621.

  PMID: 27735840 BACKGROUND

• Sole-Navais P, Salat-Batlle J, Cavalle-Busquets P, Fernandez-Ballart J, Ueland PM, Ballesteros M, Ornosa-Martin G, Ingles-Puig M, Colomina JM, Murphy MM. Early pregnancy folate-cobalamin interactions and their effects on cobalamin status and hematologic variables throughout pregnancy. Am J Clin Nutr. 2018 Feb 1;107(2):173-182. doi: 10.1093/ajcn/nqx041.

  PMID: 29529156 BACKGROUND

• Roige-Castellvi J, Murphy M, Hernandez-Martinez C, Sole-Navais P, Cavalle-Busquets P, Fernandez-Ballart J, Ballesteros M, Canals J. The effect of prenatal smoke exposure on child neuropsychological function: a prospective mother-child cohort study. J Reprod Infant Psychol. 2020 Feb;38(1):25-37. doi: 10.1080/02646838.2019.1580350. Epub 2019 Feb 19.

  PMID: 30777448 BACKGROUND

• Cavalle-Busquets P, Ingles-Puig M, Fernandez-Ballart JD, Haro-Barcelo J, Rojas-Gomez A, Ramos-Rodriguez C, Ballesteros M, Meyer K, Ueland PM, Murphy MM. Moderately elevated first trimester fasting plasma total homocysteine is associated with increased probability of miscarriage. The Reus-Tarragona Birth Cohort Study. Biochimie. 2020 Jun;173:62-67. doi: 10.1016/j.biochi.2020.01.008. Epub 2020 Jan 18.

  PMID: 31962182 BACKGROUND

• Fernandez-Roig S, Cavalle-Busquets P, Fernandez-Ballart JD, Ballesteros M, Berrocal-Zaragoza MI, Salat-Batlle J, Ueland PM, Murphy MM. Low folate status enhances pregnancy changes in plasma betaine and dimethylglycine concentrations and the association between betaine and homocysteine. Am J Clin Nutr. 2013 Jun;97(6):1252-9. doi: 10.3945/ajcn.112.054189. Epub 2013 Apr 17.

  PMID: 23595875 RESULT

• Santos-Calderon LA, Cavalle-Busquets P, Ramos-Rodriguez C, Grifoll C, Rojas-Gomez A, Ballesteros M, Ueland PM, Murphy MM. Folate and cobalamin status, indicators, modulators, interactions, and reference ranges from early pregnancy until birth: the Reus-Tarragona birth cohort study. Am J Clin Nutr. 2024 Nov;120(5):1269-1283. doi: 10.1016/j.ajcnut.2024.09.015. Epub 2024 Sep 24.

  PMID: 39326699 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Serum Leukocytes Placenta

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Michelle M Murphy, PhD

  University Rovira i Virgili

  PRINCIPAL INVESTIGATOR

• Pere Cavallé-Busquets, MD, PHD

  Hospital Universitari Sant Joan de Reus

  STUDY DIRECTOR

• Joan D Fernandez-Ballart, PhD

  University Rovira i Virgili

  STUDY CHAIR

• Mónica Ballesteros, MD, PHD

  Hospital de Tarragona Joan XXIII

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesora agregat

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: January 1, 2005
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

ES (2)