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临床试验/NCT01778205
NCT01778205已完成不适用

Phase 1 Study of the Effect of Maternal Nutritional Status on Placental Vascular Function, Fetal Growth and Intrauterine Growth Retardation.

Institut Investigacio Sanitaria Pere Virgili2 个研究点 分布在 1 个国家目标入组 831 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
831
试验地点
2
主要终点
Birth weight

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • <12 weeks pregnant at first prenatal check up

排除标准

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

结局指标

主要结局

Birth weight

时间窗: At birth

Doppler waveforms of uterine arteries

时间窗: 20 gestational weeks

次要结局

未报告次要终点

研究者

发起方
Institut Investigacio Sanitaria Pere Virgili
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Michelle Murphy

Profesora agregat

Institut Investigacio Sanitaria Pere Virgili

研究点 (2)

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