NCT03920098

Chilean Maternal & Infant Cohort Study II (CHiMINCs-II)

The Chilean Maternal and Infant Nutrition Cohort Study II

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,927 (actual)
• Sponsor: Instituto de Nutrición y Tecnología de los Alimentos · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Breast Density
• Body Composition
• Nutritional Status
• Mental Health Issue

Interventions

Type	Name	Description
OTHER	Nutrition and mental health during pregnancy	Altered metabolic milieu is defined as a fasting glucose level \>100 mg/dL at the first trimester of pregnancy by national guidelines. Altered metabolic milieu during the second trimester (24-28 weeks of pregnancy) is defined as a fasting glucose levels \> 92 mg/dL and/or plasma glucose levels \> 153 mg/dL two hours after load in the oral glucose tolerance test according to ADA guidelines or a fasting glucose \>100 mg/dL and/or \> 140 mg/dL two hours after load in the oral glucose tolerance test according to national guidelines. The COVID-19 pandemic is considered as a natural nutritional and mental health exposure.

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-07-30
• Completion: 2023-04-30
• First posted: 2019-04-18
• Last updated: 2022-02-07

Locations

1 site across 1 country: Chile