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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01778205
Recruitment Status : Recruiting
First Posted : January 29, 2013
Last Update Posted : April 24, 2017
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Dr. Michelle Murphy, Institut Investigacio Sanitaria Pere Virgili

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.

Condition or disease Intervention/treatment
Intrauterine Development Other: Observational

Study Type : Observational
Estimated Enrollment : 800 participants
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.
Study Start Date : January 2005
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Pregnant women
Pregnant women with confirmed viable fetus at first prenatal check-up at <12 gestational weeks
Other: Observational

Primary Outcome Measures :
  1. Birth weight [ Time Frame: At birth ]
  2. Doppler waveforms of uterine arteries [ Time Frame: 20 gestational weeks ]

Other Outcome Measures:
  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 ]

Biospecimen Retention:   Samples With DNA
Plasma Serum Leukocytes Placenta

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01778205

Contact: Michelle M Murphy, PhD +34 977 758924
Contact: Pere Cavallé-Busquets, MD, PhD +34 977 337336

Hospital Universitari Sant Joan de Reus Recruiting
Reus, Tarragona, Spain, 43201
Sub-Investigator: Pere Cavallé-Busquets, MD, PhD         
Sub-Investigator: Joan Fernandez-Ballart, MD, PhD         
Sub-Investigator: Pol Solé Navais, PhD         
Principal Investigator: Michelle M Murphy, PhD         
Sub-Investigator: Gemma Ornosa, MSc         
Sub-Investigator: Julia Haro Barcelo, MSc         
Sub-Investigator: Montserrat Ingles, MD         
Sub-Investigator: Montserrat Monclus, MD         
Sub-Investigator: Marta Herrero Casado, BSc         
Hospital de Tarragona Joan XXIII Completed
Tarragona, Spain, 43005
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili
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 de Tarragona Joan XXIII

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Michelle Murphy, Profesora agregat, Institut Investigacio Sanitaria Pere Virgili Identifier: NCT01778205     History of Changes
Other Study ID Numbers: IISPV_Murphy1
SPAIN MICINN ( Other Grant/Funding Number: Ministerio de Ciéncia y Innovación SAF2005/05096 )
SPAIN ISCIII ( Other Grant/Funding Number: Instituto de Salud Carlos III PI10/00335 )
SPAIN URV ( Other Grant/Funding Number: Universitat Rovira i Virgili )
SPAIN ISCIII ( Other Grant/Funding Number: Instituto de Salud Carlos III PI13/02500 )
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017