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
  Purpose

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.


Condition Intervention
Intrauterine Development
Other: Observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 1 Study of the Effect of Maternal Nutritional Status on Placental Vascular Function, Fetal Growth and Intrauterine Growth Retardation.

Further study details as provided by Institut Investigacio Sanitaria Pere Virgili:

Primary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 1-C metabolites [ Time Frame: <12, 15, 24-27, 34 gestational weeks, at labor, in the cord ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma Serum Leukocytes Placenta


Estimated Enrollment: 800
Study Start Date: January 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant women
Pregnant women with confirmed viable fetus at first prenatal check-up at <12 gestational weeks
Other: Observational

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778205

Contacts
Contact: Pere Cavallé-Busquets, MD 977 337336 pecavalle@grupsagessa.com
Contact: Mónica Ballesteros, MD, PhD

Locations
Spain
Hospitals Universitaris Sant Joan de Reus and Joan XXIII de Tarragona Recruiting
Reus and Tarragona, Tarragona, Spain, 43201
Sub-Investigator: Pere Cavallé-Busquets, MD         
Sub-Investigator: Joan Fernandez-Ballart, MD, PhD         
Sub-Investigator: Pol Solé Navais, BSc, MSc         
Sub-Investigator: Mónica Ballesteros, MD, PhD         
Principal Investigator: Michelle M Murphy, BSc, MSc, PhD         
Sub-Investigator: Jose María Colomina, BSc, MSc         
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili
Italfarmaco
Instituto de Salud Carlos III
Investigators
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.
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Michelle Murphy, Profesora agregat, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier: NCT01778205     History of Changes
Other Study ID Numbers: IISPV_Murphy1, SPAIN MICINN, SPAIN ISCIII, SPAIN URV, SPAIN ISCIII
Study First Received: January 25, 2013
Last Updated: March 14, 2014
Health Authority: SPAIN: CEIC Hospital Universitari Sant Joan Reus
SPAIN: CEIC Hospital Universitari de Tarragons Joan XXIII

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014