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临床试验/NCT03113331
NCT03113331进行中(未招募)不适用

3D Cohort Study: The Integrated Research Network in Perinatology of Quebec and Eastern Ontario

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 2,366 人开始时间: 2010年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,366
试验地点
1
主要终点
Intrauterine growth restriction

研究概览

简要总结

The 3D Cohort Study (Design, Develop, Discover) was established to help bridge knowledge gaps about the links between various adverse exposures during pregnancy with birth outcomes and later health outcomes in children.

详细描述

The main objective of the 3D study is to create a large pregnancy and birth cohort, allowing for the assessment of the effects of combined prenatal exposure on both birth outcomes and longer-term infant and child health. The specific objectives are to:

  1. Determine the effects of pre- and post-natal exposures to environmental contaminants, nutritional factors and psychosocial stress on pregnancy and neurodevelopmental outcomes;
  2. Assess the contribution of social, genetic, epigenetic, nutritional and environmental factors to the etiology and outcomes of intrauterine growth restriction (IUGR) and preterm birth; and
  3. Assess the effects of assisted reproductive technologies (ART) on indicators of epigenetic modifications, and the relationship between such epigenetic changes and infant neurodevelopmental, cardiovascular, and metabolic outcomes.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Able to communicate in French or English

排除标准

  • Current intravenous drug use
  • Severe illnesses or life threatening conditions
  • Multiple gestation pregnancies

结局指标

主要结局

Intrauterine growth restriction

时间窗: At delivery

Birth weight smaller than 10th percentile

Neurodevelopment - Sensory Profile

时间窗: When infants are 2 years old

Neurodevelopmental assessment of the infant. Test used : Sensory Profile questionnaire. This test was done on 1520 children.

Preterm birth

时间窗: At delivery

Delivery before 37 weeks of gestation

Neurodevelopment - ABAS

时间窗: When infants are 2 years old

Neurodevelopmental assessment of the infant. Test used : Bayley Adaptive Behaviour Questionnaire (ABAS-II). This test was done on 1520 children.

Neurodevelopment - Bayley

时间窗: When infants are 2 years old

Neurodevelopmental assessment of the infant. Test used : Bayley Scales of Infant and Toddler Development (BSID-III; cognitive scale and motor scale combined). This test was done on 1520 children.

Neurodevelopment - MacArthur-Bates

时间窗: When infants are 2 years old

Neurodevelopmental assessment of the infant. Test used : MacArthur Communicative Development Inventories (CDI; French, English, Spanish and/or Mandarin). This test was done on 1520 children.

Neurodevelopment - M-CHAT

时间窗: When infants are 2 years old

Neurodevelopmental assessment of the infant. Test used : Modified Checklist of Autism in Toddlers (M-CHAT). This test was done on 1520 children.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Fraser

Professor

Université de Sherbrooke

研究点 (1)

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