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临床试验/NCT03920098
NCT03920098Unknown不适用

The Chilean Maternal and Infant Nutrition Cohort Study II

Instituto de Nutrición y Tecnología de los Alimentos1 个研究点 分布在 1 个国家目标入组 1,927 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,927
试验地点
1
主要终点
Edinburg Postnatal Depression Scale

研究概览

简要总结

The Chilean Maternal & Infant Cohort Study II (ChiMINCs II) is an ongoing cohort that is part of the Chilean Maternal and Infant Nutrition Observatory of the South-East area of Santiago, Chile. In total, 1927 pregnant women beneficiaries of the public health systems and their offspring were recruited before 12 weeks of gestation and are followed across pregnancy (<15, 26-28, and 35-37 weeks of gestation) and up to 2 years of age of their offspring. Two studies are currently nested in ChiMINCs II: 1) Breast Cancer Risk Assessment in Mothers (BRECAM) study, and 2) the ChiMINCs-COVID study. The primary objective of BRECAM study is to test the association between maternal metabolic indicators (i.e., insulin, glucose, IGF-1, and HbAc1 concentrations) at early pregnancy (i.e., <15 and 26-28 weeks of gestation) and breast density 3 months after the cessation of lactation. For this purpose, we collect maternal obstetric, lifestyle, dietary intake, anthropometric, and biochemical information. The aim of the ChiMINCs-COVID study is to assess dietary-related risks and mental health problems derived from the COVID-19 pandemic and their influence on maternal and infant's health and nutrition. Thus, we collected detailed information on dietary behaviors, mental health and COVID-related information at each trimester, along with neonatal and infant nutritional information. The purpose of the present work is to describe the design, methods, and descriptive information at recruitment of ChiMINCs-II, also discussing the implications that this study can have to better understand maternal and infant nutrition and health during the COVID-19 era.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 or more years of age
  • Gestation <15 weeks at first prenatal visit
  • No intention to move outside the city of Santiago in the next to years

排除标准

  • High-risk pregnancy (i.e., preeclampsia, pre- existing diabetes)
  • Pre-existing cancer or family history of breast cancer
  • Intended to migrate from the public to the private health care system

结局指标

主要结局

Edinburg Postnatal Depression Scale

时间窗: Through the gestation, up to 6 months

Score

Pandemic Anxiety Scale

时间窗: Through the gestation, up the delivery

Score

Pregnancy Risk Assessment Monitoring System

时间窗: Through the gestation, up the delivery

Score

Breast absolute percentage (%FVG) of fibro-glandular volume measured by DXA technique

时间窗: Three months after breastfeeding cessation

percentage

Glucose concentration

时间窗: Through the gestation, up the delivery

mg/dL

Insulin concentration

时间窗: Through the gestation, up the delivery

uIU/mL

Breast absolute (AFGV) fibro-glandular volume measured by DXA technique

时间窗: Three months after breastfeeding cessation

cm3

Gestational weight gain

时间窗: At delivery

kg

Gestational Diabetes

时间窗: At delivery

Percentage of mothers diagnosed

次要结局

  • Offspring head circumference(At 6 months of age)
  • Offspring body fat(At 6 months of age)
  • Offspring length(At 6 months of age)
  • Offspring weight(At 6 months of age)

研究者

发起方
Instituto de Nutrición y Tecnología de los Alimentos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Maria Luisa Garmendia

Associate Professor

Instituto de Nutrición y Tecnología de los Alimentos

研究点 (1)

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