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| Name | Class |
|---|---|
| Pontificia Universidad Catolica de Chile | OTHER |
| Servicio de Salud Metropolitano Sur Oriente | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother-infant dyads | Mother-infant dyads |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Offspring weight | g | At 6 months of age |
| Offspring length | cm | At 6 months of age |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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.
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa L Garmendia, PhD | Instituto de Nutrición y TecnologÃa de Alimentos | Principal Investigator |
| Camila L Corvalán Aguilar, PhD | Institute of Nutrition and Food Technology (INTA), University of Chile, Chile | Principal Investigator |
| MarÃa F Mujica Coopman, PhD | Institute of Nutrition and Food Technology (INTA), University of Chile, Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporación de Salud Municipal de Puente Alto | Santiago | Puente Alto | 8210269 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16775176 | Background | 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. | |
| 17229950 | 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. |
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Data and blood samples that will be collected in this study will be under the custody of the principal investigator and a human subject protection review board will regulate its use. Others researchers may access the data by contacting to MarÃa Luisa Garmendia (Principal Investigator).
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D044882 | Glucose Metabolism Disorders |
| D016640 | Diabetes, Gestational |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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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.
|
Score
| Through the gestation, up the delivery |
| Offspring head circumference | cm | At 6 months of age |
| Offspring body fat | Percentage | At 6 months of age |
| 29514672 | 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. |
| 15734956 | 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. |
| 12239257 | 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. |
| 22266113 | 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. |
| 29651637 | 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. |
| 28478536 | 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. |
| 27351801 | 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. |
| 26475982 | 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. |
| 12133652 | 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. |
| 29603032 | 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. |
| 18045947 | 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. |
| 23345353 | 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. |
| 18180221 | 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. |
| 20700056 | 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. |
| 14999138 | 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. |
| 21415236 | 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. |
| 19361966 | 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. |
| 27832382 | 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. |
| 28132392 | 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. |
| 25619201 | 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. |
| 35910889 | Derived | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D003710 | Demography |
| D011154 | Population Characteristics |