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Study Title and Description

Maternal caffeine consumption and sine causa recurrent miscarriage.



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 sine causa recurrent miscarriage.
Author EM Stefanidou,L Caramellino,A Patriarca,G Menato,
Country
Year 2011
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 21636205
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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 objective of this study was to examine whether the risk of sine causa recurrent miscarriage is related to caffeine consumption during the periconceptional period and early gestation.
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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) A retrospective case–control study was conducted in the Department of Obstetrics and Gynecology, University of Turi. Fifty-two sine causa recurrent miscarriers and 260 healthy pregnant women were assessed. Recurrent miscarriers among the 292 couples who had attended the ‘Diagnostic and Treatment Center for recurrent miscarriages’. Fifty-two women agreed to participate in the study and underwent a telephone interview. Karyotype analyses of the abortive material were normal. The mean number of miscarriages in the case group was 3.52. All the women in the study were Caucasic. For controls, pathologic conditions which could affect the obstetric outcome were exclusion criteria. Interviews were conducted by the same interviewer, using a structured questionnaire. All the participants were asked to report specific sources of caffeine intake, 4 weeks before their last menstrual period (LMP) through the last gestational week before miscarriage or delivery. Caffeine sources included coffee (caffeinated or decaffeinated), tea, cocoa, chocolate and cola. Responses were given using frequency categories and cup/bar sizes. Women were asked about changes in consumption pattern from the moment they had become pregnant, and, if so, the frequency and the amount of consumption after the changes. Average daily caffeine intake was then calculated using conversion factors based on mean company data (see Table). Differences between groups for quantitative variables were evaluated with Wilcoxon–Mann–Whitney test, while associations between categorical variables with Fisher’s exact test and/or odds ratio (OR) (through Pearson’s chi-square test) and relative 95% confidence interval (95% CI). Variables which resulted significant in the univariate analysis were used in the estimation of a logistic regression model to evaluate the effect of caffeine on recurrent miscarriage, taking into account some possible confounding factors. Caffeine content of food and beverage sources as reported by companies. Source Volume or weight Caffeine content (mg) Range Average Espresso coffee (caffeinated) 50 ml 60–145 102.5 Moka coffee (caffeinated) 50 ml 60–112 86 Soluble/instant coffee 50 ml 63.5–82.5 73 Decaffeinated coffee 50 ml 0.5–5.5 3 Caffeinated tea 150 ml 40–50 45 Decaffeinated tea 150 ml 1–5 3 Cola 100 ml 10.6–15.4 13 Hot chocolate 150 ml 9.5–13.5 11.5 Chocolate 25 g 8–25 16.5
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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) Repeated pregnancy loss
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes Authors defines as sin causa recurrent miscarriage
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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 Recurrent miscarriers attended the ‘Diagnostic and Treatment Center for recurrent miscarriages’. Karyotype analyses of the abortive material were normal.
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Caffeine (general) Caffeine (general)
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Coffee Coffee
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Chocolate Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda Soda
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Tea 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.) Caffeine mg/day: </=150.9, 151-300.9, >/=301
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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) Data carried forward for PECO were NOT adjusted. However, in the regression analysis used also performed, the following confounding factors were taken into account in the study, on the basis of scientific literature (even if sometimes controversially): age at conception, pregravidic BMI, cigarette smoking since LMP, alcohol consumption since LMP, exposure to toxicants since LMP, educational level, nausea/vomiting since LMP. Along with these variables referred to women, we considered the partner’s educational level, as it contributes to the socioeconomic status of the couple, related to the obstetric outcome.
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Provide a general description of results (as reported by the authors). Not taking into account possible confounding factors. Compared to women in the lower consumption category, in women in the intermediate and upper consumption categories the ORs were respectively 3.045 (95% CI: 1.237– 7.287, p = 0.012) and 16.106 (95% CI: 6.547–39.619, p < 0.00). A logistic regression model was estimated, to evaluate the effect of caffeine on the risk of sine causa recurrent miscarriage, taking into account as confounding variables those resulting significant in the multivariate analysis. A linear association between the amount of daily caffeine intake and the risk of multiple reproductive failures was found: for each increase of 100 mg/day in caffeine intake, the OR for sine causa recurrent miscarriage showed an increase of 2.724 (p = 0.001, 95% CI: 2.715– 2.733).
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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? A linear association between the amount of daily caffeine intake and the risk of multiple reproductive failures was found: for each increase of 100 mg/day in caffeine intake, the OR for sine causa recurrent miscarriage showed an increase of 2.724 (p = 0.001, 95% CI: 2.715– 2.733).
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What were the author's conclusions? In conclusion, our study highlighted that early caffeine intake can represent a risk factor for sine causa recurrent miscarriage. Therefore it may be wise to reduce caffeine intake during the periconceptional period and early gestation. However, further clinical studies are required before the information is used in clinical setting, to evaluate the relationship between lifestyle and recurrent miscarriage.
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What were the sources of funding? None reported
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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.  RPL: LOAEL = 151-300.9 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. Unadjusted ORs were 3.045 (95% CI: 1.237– 7.287, p = 0.012) and 16.106 (95% CI: 6.547–39.619, p < 0.00), for 151-300.9 and >/=301 mg/day, respectively. Regression analysis adjusted for confounders showed an increase of 2.724 (p = 0.001, 95% CI: 2.715– 2.733) for each increase of 100 mg/day.
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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