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

The Chilean Maternal and Infant Nutrition Cohort Study II

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03920098
Acronym
CHiMINCs-II
Enrollment
1927
Registered
2019-04-18
Start date
2019-06-01
Completion date
2023-04-30
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Breast densities, Breast neoplasms, Glucose metabolism disorders, Diabetes, gestational, Pregnancy, Nutritional status, Mental health, Body composition, Growth and development, Primary Health Care, Dual-energy X-ray Absorptiometry, Latin America, Chile

Brief 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.

Interventions

OTHERNutrition 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.

Sponsors

Pontificia Universidad Catolica de Chile
CollaboratorOTHER
Servicio de Salud Metropolitano Sur Oriente
CollaboratorOTHER_GOV
Instituto de Nutrición y Tecnología de los Alimentos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pandemic Anxiety ScaleThrough the gestation, up the deliveryScore
Pregnancy Risk Assessment Monitoring SystemThrough the gestation, up the deliveryScore
Edinburg Postnatal Depression ScaleThrough the gestation, up to 6 monthsScore
Glucose concentrationThrough the gestation, up the deliverymg/dL
Insulin concentrationThrough the gestation, up the deliveryuIU/mL
Breast absolute (AFGV) fibro-glandular volume measured by DXA techniqueThree months after breastfeeding cessationcm3
Breast absolute percentage (%FVG) of fibro-glandular volume measured by DXA techniqueThree months after breastfeeding cessationpercentage
Gestational weight gainAt deliverykg
Gestational DiabetesAt deliveryPercentage of mothers diagnosed

Secondary

MeasureTime frameDescription
Offspring lengthAt 6 months of agecm
Offspring head circumferenceAt 6 months of agecm
Offspring body fatAt 6 months of agePercentage
Offspring weightAt 6 months of ageg

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026