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

NCT03920098 | Unknown

• 1 other identifier: 1190532
• Study Type: observational
• Target: 1,927
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (9)

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

  cm3

  Three months after breastfeeding cessation

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

  percentage

  Three months after breastfeeding cessation

• Gestational weight gain

  kg

  At delivery

• Gestational Diabetes

  Percentage of mothers diagnosed

  At delivery

• Pregnancy Risk Assessment Monitoring System

  Score

  Through the gestation, up the delivery

• Edinburg Postnatal Depression Scale

  Score

  Through the gestation, up to 6 months

• Glucose concentration

  mg/dL

  Through the gestation, up the delivery

• Insulin concentration

  uIU/mL

  Through the gestation, up the delivery

• Pandemic Anxiety Scale

  Score

  Through the gestation, up the delivery

Secondary Outcomes (4)

• Offspring weight

  At 6 months of age

• Offspring length

  At 6 months of age

• Offspring head circumference

  At 6 months of age

• Offspring body fat

  At 6 months of age

Study Arms (1)

Mother-infant dyads

Mother-infant dyads

Other: Nutrition and mental health during pregnancy

Interventions

Nutrition and mental health during pregnancy OTHER

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.

Mother-infant dyads

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

We identified pregnant women who received primary prenatal care within PHCC located in the South East area of Santiago. After, offspring of pregnant women were followed postnatally.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Nutrición y Tecnología de los Alimentos: lead
• Pontificia Universidad Catolica de Chile: collaborator
• Servicio de Salud Metropolitano Sur Oriente: collaborator

Study Sites (1)

Corporación de Salud Municipal de Puente Alto

Santiago, Puente Alto, 8210269, Chile

Location

Related Publications (23)

• McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006 Jun;15(6):1159-69. doi: 10.1158/1055-9965.EPI-06-0034.

  PMID: 16775176 BACKGROUND

• Boyd NF, Guo H, Martin LJ, Sun L, Stone J, Fishell E, Jong RA, Hislop G, Chiarelli A, Minkin S, Yaffe MJ. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 2007 Jan 18;356(3):227-36. doi: 10.1056/NEJMoa062790.

  PMID: 17229950 BACKGROUND

• Boyd N, Berman H, Zhu J, Martin LJ, Yaffe MJ, Chavez S, Stanisz G, Hislop G, Chiarelli AM, Minkin S, Paterson AD. The origins of breast cancer associated with mammographic density: a testable biological hypothesis. Breast Cancer Res. 2018 Mar 7;20(1):17. doi: 10.1186/s13058-018-0941-y.

  PMID: 29514672 BACKGROUND

• Li T, Sun L, Miller N, Nicklee T, Woo J, Hulse-Smith L, Tsao MS, Khokha R, Martin L, Boyd N. The association of measured breast tissue characteristics with mammographic density and other risk factors for breast cancer. Cancer Epidemiol Biomarkers Prev. 2005 Feb;14(2):343-9. doi: 10.1158/1055-9965.EPI-04-0490.

  PMID: 15734956 BACKGROUND

• Boyd NF, Dite GS, Stone J, Gunasekara A, English DR, McCredie MR, Giles GG, Tritchler D, Chiarelli A, Yaffe MJ, Hopper JL. Heritability of mammographic density, a risk factor for breast cancer. N Engl J Med. 2002 Sep 19;347(12):886-94. doi: 10.1056/NEJMoa013390.

  PMID: 12239257 BACKGROUND

• Varghese JS, Thompson DJ, Michailidou K, Lindstrom S, Turnbull C, Brown J, Leyland J, Warren RM, Luben RN, Loos RJ, Wareham NJ, Rommens J, Paterson AD, Martin LJ, Vachon CM, Scott CG, Atkinson EJ, Couch FJ, Apicella C, Southey MC, Stone J, Li J, Eriksson L, Czene K, Boyd NF, Hall P, Hopper JL, Tamimi RM; MODE Consortium; Rahman N, Easton DF. Mammographic breast density and breast cancer: evidence of a shared genetic basis. Cancer Res. 2012 Mar 15;72(6):1478-84. doi: 10.1158/0008-5472.CAN-11-3295. Epub 2012 Jan 19.

  PMID: 22266113 BACKGROUND

• Nazari SS, Mukherjee P. An overview of mammographic density and its association with breast cancer. Breast Cancer. 2018 May;25(3):259-267. doi: 10.1007/s12282-018-0857-5. Epub 2018 Apr 12.

  PMID: 29651637 BACKGROUND

• Rice MS, Rosner BA, Tamimi RM. Percent mammographic density prediction: development of a model in the nurses' health studies. Cancer Causes Control. 2017 Jul;28(7):677-684. doi: 10.1007/s10552-017-0898-7. Epub 2017 May 6.

  PMID: 28478536 BACKGROUND

• Yaghjyan L, Colditz GA, Rosner B, Bertrand KA, Tamimi RM. Reproductive factors related to childbearing and mammographic breast density. Breast Cancer Res Treat. 2016 Jul;158(2):351-9. doi: 10.1007/s10549-016-3884-y. Epub 2016 Jun 28.

  PMID: 27351801 BACKGROUND

• Rice MS, Bertrand KA, Lajous M, Tamimi RM, Torres G, Lopez-Ridaura R, Romieu I. Reproductive and lifestyle risk factors and mammographic density in Mexican women. Ann Epidemiol. 2015 Nov;25(11):868-73. doi: 10.1016/j.annepidem.2015.08.006. Epub 2015 Aug 29.

  PMID: 26475982 BACKGROUND

• Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and breastfeeding: collaborative reanalysis of individual data from 47 epidemiological studies in 30 countries, including 50302 women with breast cancer and 96973 women without the disease. Lancet. 2002 Jul 20;360(9328):187-95. doi: 10.1016/S0140-6736(02)09454-0.

  PMID: 12133652 BACKGROUND

• Gabrielson M, Chiesa F, Behmer C, Ronnow K, Czene K, Hall P. Association of reproductive history with breast tissue characteristics and receptor status in the normal breast. Breast Cancer Res Treat. 2018 Aug;170(3):487-497. doi: 10.1007/s10549-018-4768-0. Epub 2018 Mar 30.

  PMID: 29603032 BACKGROUND

• Britt K, Ashworth A, Smalley M. Pregnancy and the risk of breast cancer. Endocr Relat Cancer. 2007 Dec;14(4):907-33. doi: 10.1677/ERC-07-0137.

  PMID: 18045947 BACKGROUND

• Vashi R, Hooley R, Butler R, Geisel J, Philpotts L. Breast imaging of the pregnant and lactating patient: imaging modalities and pregnancy-associated breast cancer. AJR Am J Roentgenol. 2013 Feb;200(2):321-8. doi: 10.2214/ajr.12.9814.

  PMID: 23345353 BACKGROUND

• Sabate JM, Clotet M, Torrubia S, Gomez A, Guerrero R, de las Heras P, Lerma E. Radiologic evaluation of breast disorders related to pregnancy and lactation. Radiographics. 2007 Oct;27 Suppl 1:S101-24. doi: 10.1148/rg.27si075505.

  PMID: 18180221 BACKGROUND

• Loehberg CR, Heusinger K, Jud SM, Haeberle L, Hein A, Rauh C, Bani MR, Lux MP, Schrauder MG, Bayer CM, Helbig C, Grolik R, Adamietz B, Schulz-Wendtland R, Beckmann MW, Fasching PA. Assessment of mammographic density before and after first full-term pregnancy. Eur J Cancer Prev. 2010 Nov;19(6):405-12. doi: 10.1097/CEJ.0b013e32833ca1f4.

  PMID: 20700056 BACKGROUND

• Strange KS, Wilkinson D, Edin G, Emerman JT. Mitogenic properties of insulin-like growth factors I and II, insulin-like growth factor binding protein-3 and epidermal growth factor on human breast stromal cells in primary culture. Breast Cancer Res Treat. 2004 Mar;84(2):77-84. doi: 10.1023/B:BREA.0000018384.64326.dd.

  PMID: 14999138 BACKGROUND

• Rosato V, Bosetti C, Talamini R, Levi F, Montella M, Giacosa A, Negri E, La Vecchia C. Metabolic syndrome and the risk of breast cancer in postmenopausal women. Ann Oncol. 2011 Dec;22(12):2687-2692. doi: 10.1093/annonc/mdr025. Epub 2011 Mar 17.

  PMID: 21415236 BACKGROUND

• Agnoli C, Berrino F, Abagnato CA, Muti P, Panico S, Crosignani P, Krogh V. Metabolic syndrome and postmenopausal breast cancer in the ORDET cohort: a nested case-control study. Nutr Metab Cardiovasc Dis. 2010 Jan;20(1):41-8. doi: 10.1016/j.numecd.2009.02.006. Epub 2009 Apr 10.

  PMID: 19361966 BACKGROUND

• Buschard K, Thomassen K, Lynge E, Vejborg I, Tjonneland A, von Euler-Chelpin M, Andersen ZJ. Diabetes, diabetes treatment, and mammographic density in Danish Diet, Cancer, and Health cohort. Cancer Causes Control. 2017 Jan;28(1):13-21. doi: 10.1007/s10552-016-0829-z. Epub 2016 Nov 10.

  PMID: 27832382 BACKGROUND

• Pereira A, Garmendia ML, Uauy R, Neira P, Lopez-Arana S, Malkov S, Shepherd J. Determinants of volumetric breast density in Chilean premenopausal women. Breast Cancer Res Treat. 2017 Apr;162(2):343-352. doi: 10.1007/s10549-017-4126-7. Epub 2017 Jan 28.

  PMID: 28132392 BACKGROUND

• Chen YH, Ferguson KK, Meeker JD, McElrath TF, Mukherjee B. Statistical methods for modeling repeated measures of maternal environmental exposure biomarkers during pregnancy in association with preterm birth. Environ Health. 2015 Jan 26;14:9. doi: 10.1186/1476-069X-14-9.

  PMID: 25619201 BACKGROUND

• Mujica-Coopman MF, Corvalan C, Flores M, Garmendia ML. The Chilean Maternal-Infant Cohort Study-II in the COVID-19 Era: A Study Protocol. Front Public Health. 2022 Jul 14;10:904668. doi: 10.3389/fpubh.2022.904668. eCollection 2022.

  PMID: 35910889 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Additional fasting venous samples will be collected during routine public health care blood extractions and at delivery (maternal venous and umbilical cord blood samples). Also, feces samples of newborn will be collected after delivery. Whole blood, plasma, buffy coat, serum and red blood cells will be separated by centrifugation within the next 3 hours. Biological specimens will be aliquot and keep to -80ºC until the determination of metabolic markers, growth factors and hormones.

MeSH Terms

Conditions

Breast Neoplasms; Glucose Metabolism Disorders; Diabetes, Gestational; Psychological Well-Being

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Endocrine System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• María L Garmendia, PhD

  Instituto de Nutrición y Tecnología de Alimentos

  PRINCIPAL INVESTIGATOR

• Camila L Corvalán Aguilar, PhD

  Institute of Nutrition and Food Technology (INTA), University of Chile, Chile

  PRINCIPAL INVESTIGATOR

• María F Mujica Coopman, PhD

  Institute of Nutrition and Food Technology (INTA), University of Chile, Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 18, 2019
• Study Start: June 1, 2019
• Primary Completion: July 30, 2022
• Study Completion: April 30, 2023
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)