Clinical trial NCT01778205: The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.
Official title: Phase 1 Study of the Effect of Maternal Nutritional Status on Placental Vascular Function, Fetal Growth and Intrauterine Growth Retardation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Development
Lead sponsor: Institut Investigacio Sanitaria Pere Virgili
Sponsor class: OTHER
Collaborators: name: Italfarmaco
name: Instituto de Salud Carlos III
name: State Research Agency, Spain
name: JPI ERA-HDHL
name: University Rovira i Virgili
name: European Regional Development Fund
First posted: 2013-01-29
Enrollment: 831
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility 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

Primary outcomes:
measure: Birth weight
timeFrame: At birth
measure: Doppler waveforms of uterine arteries
timeFrame: 20 gestational weeks
Secondary outcomes:
Other outcomes:
measure: 1-C metabolites
timeFrame: <12, 15, 24-27, 34 gestational weeks, at labor, in the cord
measure: Intrauterine growth retardation
timeFrame: At birth
Locations:
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
city: Tarragona
country: Spain
facility: Hospital de Tarragona Joan XXIII
Study officials:
affiliation: University Rovira i Virgili
name: Michelle M Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Sant Joan de Reus
name: Pere Cavallé-Busquets, MD, PHD
role: STUDY_DIRECTOR
affiliation: University Rovira i Virgili
name: Joan D Fernandez-Ballart, PhD
role: STUDY_CHAIR
affiliation: Hospital de Tarragona Joan XXIII
name: Mónica Ballesteros, MD, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.