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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Institut Investigacio Sanitaria Pere Virgili
Sponsor:
Collaborators:
Italfarmaco
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Dr. Michelle Murphy, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier:
NCT01778205
First received: January 25, 2013
Last updated: March 14, 2014
Last verified: March 2014

January 25, 2013
March 14, 2014
January 2005
December 2014   (final data collection date for primary outcome measure)
  • Birth weight [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • Doppler waveforms of uterine arteries [ Time Frame: 20 gestational weeks ] [ Designated as safety issue: No ]
  • Intrauterine growth retardation [ Time Frame: At birth ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01778205 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
1-C metabolites [ Time Frame: <12, 15, 24-27, 34 gestational weeks, at labor, in the cord ] [ Designated as safety issue: No ]
Same as current
 
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.

The gradual fall in birth and death rates, over the past decades, have resulted in demographic changes that are characterised by low fertility and high life expectancy. As a result, the number of older people in Europe is rapidly increasing and The World Health Organization reports the median age of the European population as the highest in the world and predicts that the proportion of over-60s in the WHO European Region will increase from 14% in 2010 to 25% in 2050. However, 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 data from the early life 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. This first phase investigated the association between gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy outcome. The upcoming second phase of this study will follow up the children at 7.5 years of age. Growth, exercise and nutritional habits as well as environment and cognitive development will be 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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma Serum Leukocytes Placenta

Non-Probability Sample

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)

Intrauterine Development
Other: Observational
Pregnant women
Pregnant women with confirmed viable fetus at first prenatal check-up at <12 gestational weeks
Intervention: Other: Observational
Fernàndez-Roig S, Cavallé-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact: Pere Cavallé-Busquets, MD 977 337336 pecavalle@grupsagessa.com
Contact: Mónica Ballesteros, MD, PhD
Spain
 
NCT01778205
IISPV_Murphy1, SPAIN MICINN, SPAIN ISCIII, SPAIN URV, SPAIN ISCIII
Yes
Dr. Michelle Murphy, Institut Investigacio Sanitaria Pere Virgili
Institut Investigacio Sanitaria Pere Virgili
  • Italfarmaco
  • Instituto de Salud Carlos III
Principal Investigator: Michelle M Murphy, PhD Universitat Rovira i Virgili
Study Director: Pere Cavallé-Busquets, MD, PHD Hospital Universitari Sant Joan de Reus
Study Chair: Joan D Fernandez-Ballart, PhD Universitat Rovira i Virgili
Study Director: Mónica Ballesteros, MD, PHD Hospital Universitari Joan XXIII de Tarragona.
Institut Investigacio Sanitaria Pere Virgili
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP