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Study Title and Description

Maternal caffeine consumption and fetal death: a case-control study in Uruguay.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on reproductive and developmental outcomes?
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Primary Publication Information
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TitleData
Title Maternal caffeine consumption and fetal death: a case-control study in Uruguay.
Author A Matijasevich,FC Barros,IS Santos,A Yemini,
Country
Year 2006
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Reproductive Toxicity - Design Details
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 16466428
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What outcome is being evaluated in this paper? Reproductive and Development
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What is the objective of the study (as reported by the authors)? The purpose of this study was to examine the association between caffeine intake during pregnancy and fetal mortality in Montevideo, the capital city of Uruguay, taking into account several potential confounding factors.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) In Uruguay - cases consisted of women hospitalized with a medically confirmed diagnosis of spontaneous antepartum fetal death, in all maternity hospitals during the study period. Fetal deaths were included if they were of at least 20 weeks’ gestational age or weighed >350 g. Controls were women who had a live, vigorous and term adequate-for-gestational-age newborn. Structured interviews of mothers of cases and controls, most of them during the first 24 h after birth. For coffee and mate, the frequency of consumption per day was obtained separately for each trimester of pregnancy using a questionnaire tested in a previous study. For coffee, information was collected on the usual method of preparation, the size of the serving and the reported strength of the preparation. According to previous research, strong coffee has a caffeine content of 0.25 mg/mL, medium strength coffee 0.20 mg/mL and weak coffee a caffeine content of 0.11 mg/mL. The same source established for mate drinking an amount of 0.17 mg/mL. For instant coffee, information was collected about the size of spoon used (full coffee spoon, 2.6 g; level coffee spoon, 2.3 g; full small coffee spoon, 2.5 g; level small coffee spoon, 1.5 g; full dessert spoon, 7.5 g; and level desert spoon, 7.0 g) and the number of spoons used to serve it. For this kind of coffee, the manufacturer’s information of an average of 3 mg of caffeine per gram of powder was used. Associations between fetal death and the independent variables were explored using the chi-squared test, with statistical significance defined as a two-tailed P-value below 0.05. Bivariable and multivariable analysis were carried out using logistic regression.
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Fetal death (late miscarriage)
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes Fetal death between 20 weeks and antepartum.
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Clinical Clinical
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Physiological
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Other Other
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What is the study design? Case-Control
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Objective
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Optional: Name of Method or short description hospitalized with a medically confirmed diagnosis of spontaneous antepartum fetal death
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Caffeine (general) Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda
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Tea
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Measured
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Self-report Self-report
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Children
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Adolescents
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Adults
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Pregnant Women Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) Mean caffeine: 0,1-59,60-149,150-299, >/=300 mg/day
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) Adjusted for maternal and partner’s education, history of abortions and/or fetal deaths, vomiting/nausea during the first trimester and attendance for prenatal care. The following variables were found not to act as confounders and were omitted from the adjusted analyses: crowding, maternal age, pre-gestational BMI, parity and morbidity during pregnancy (gestational hypertension, gestational diabetes, anaemia, premature labour, bleeding and premature rupture of membranes).
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Provide a general description of results (as reported by the authors). Caffeine intake during pregnancy was significantly associated with fetal mortality (P<0.001), and a dose–response effect of an increased risk of fetal death with higher caffeine intakes during pregnancy was observed (P for trend 0.001). After controlling for all potential confounders, caffeine intake remained significantly associated with fetal death (P for trend <0.001); mean caffeine intake of ≥300 mg/day showed a significantly increased riskof fetal death (OR 2.33, 95% CI 1.23; 4.41) compared with no caffeine consumption during pregnancy.
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Did the authors perform a dose-response analysis (or trend/related analysis)? Yes
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What were the authors's observations re: trend analysis? After controlling for all potential confounders, caffeine intake remained significantly associated with fetal death (P for trend <0.001).
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What were the author's conclusions? To our knowledge, this is the first report of mate drinking as a source of caffeine being investigated in relation to fetal death. As mate drinking is widely distributed in Uruguay with high frequencies of consumption among pregnant women, the association found with fetal death makes it a preventable risk factor in this population.
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What were the sources of funding? The study received financial support from PAHO/ WHO (Research Grants Program). Alicia Matijasevich was supported by a grant from CAPES/Brazil.
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What conflicts of interest were reported? None reported
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Does the exposure (dose) need to be standardized to the SR? No
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest).
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  Fetal death (late miscarriage) LOAEL = >/=300 mg/day NOAEL = 299 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. Variable Adjusted OR [95% CI] Mean caffeine consumption during pregnancy (mg/day) 0 1.00 Reference 1–59 0.74 [0.42, 1.31] 60–149 0.93 [0.51, 1.67] 150–299 1.22 [0.69, 2.17] ≥300 2.33 [1.23, 4.41]
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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