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Study Title and Description

Risk of spina bifida and maternal cigarette, alcohol, and coffee use during the first month of pregnancy.



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 Risk of spina bifida and maternal cigarette, alcohol, and coffee use during the first month of pregnancy.
Author CM Benedum,MM Yazdy,AA Mitchell,MM Werler,
Country
Year 2013
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 23917813
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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)? Utilizing data collected in the Boston University Slone Epidemiology Center Birth Defects Study, we tested the hypotheses that the risk of SB is associated with smoking, alcohol drinking, and coffee consumption during the first 28 days after the last menstrual period (LMP). Additionally, we investigated whether the risk would be greater in women who failed to ingest the recommended amount of folic acid.
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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) The Slone Epidemiology Center Birth Defects Study is an on-going case-control study in North America. Between 1988–2012, this multi-center case-control study interviewed mothers of 776 SB cases and 8,756 controls about pregnancy events and exposures. Beginning in 1990, therapeutic abortions after 12 weeks’ gestation and fetal deaths occurring after 20 weeks’ gestation were eligible for the study if identified; however, these pregnancies were not routinely ascertained. Beginning in 1993, the study began ascertaining non-malformed controls from the same birth population that gave rise to cases. For the years prior to 1993, infants born with major malformations other than the one under study or those born with only minor malformations (e.g., hip clicks, toe anomalies) or nonstructural defects (e.g., cystic fibrosis) were used as controls. Cases were then reviewed by a clinical geneticist to ensure that they met the case definition. We evaluated cigarette smoking, frequency of alcohol drinking, and caffeine intake during the first lunar month of pregnancy in relation to SB risk. Maternal interviews were conducted within six months of delivery by trained study nurses; interviews were conducted in person until 1998 and, thereafter by telephone. To assess dietary intake, the long version Willett Food Frequency Questionnaire (FFQ) was administered from 1988–1997; it was replaced with a modified, shortened, version in 1998. From 1998 through 2012, mothers were asked about the average number of cups of caffeinated coffee, tea, and soda consumed two months before and during their pregnancy; changes in frequency and the timing of any changes were also recorded. Before 1998, data on changes in frequency use were not collected. Changes in the interview occurring in 2005 led to different categorizations for tea and soda that were incompatible with previous years and therefore the main analysis was restricted to coffee intake from 1998 through 2012. Logistic regression models were used to calculate adjusted odds ratios and 95% confidence intervals
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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) Spina bifida
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes
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Clinical Clinical
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Physiological
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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 Cases were then reviewed by a clinical geneticist to ensure that they met the case definition.
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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 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.) Coffee cups/day: <1, 1, >/=2
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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) Sociodemographic factors that were considered as potential confounders included: maternal race/ethnicity (non-Hispanic White, non-Hispanic Black, Hispanic, other), maternal age (<20, 20–24, 25–29, 30–34, ≥35 years), maternal education (<12, 12, >12 years), study center (Boston, MA, USA; Philadelphia, PA, USA; Toronto, ON, Canada; San Diego county, CA, USA; New York State, USA), body mass index (underweight, normal, overweight, obese; available for 1993 onward), non-steroidal anti-inflammatory (NSAID) drug use (yes, no), use of medication that is to known be a folic acid antagonist (yes, no), and amount of FA intake (<400 μg/day, ≥400 μg/day).
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Provide a general description of results (as reported by the authors). Compared to mothers who reported consuming no coffee, no increase in risk was observed for daily coffee drinkers (<1 cup/day aOR: 0.7, 95% CI: 0.4, 1.1; 1 cup/day aOR: 0.9, 95% CI: 0.6, 1.3; >2 cups/day aOR: 0.6, 95% CI: 0.3, 1.2). Furthermore, there was no observed change in risk among mothers who had low intake levels of folic acid. When other sources of caffeine were included for the sensitivity analysis, no elevated risks were identified (<1 cup/day aOR: 0.8, 95% CI: 0.5, 1.4; 1 cup/day aOR: 0.9, 95% CI: 0.4, 1.6; ≥2 cups/day: aOR: 1.0, 95% CI: 0.6, 1.7). Exclusion of women with pregestational diabetes did not result in any observable changes in aORs (<1 cup/day aOR: 0.7, 95% CI: 0.5, 1.4; 1 cup/day aOR: 0.9, 95% CI: 0.6, 1.3; ≥2 cups/day: aOR: 0.6, 95% CI: 0.3, 1.2) (data not shown).
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? We have investigated the association between the risk of SB and periconceptional cigarette, alcohol, and coffee consumption, using a large geographically diverse case-control study. Our findings suggest that there is no increased risk for SB among women who consumed cigarettes, alcohol, and caffeine. This observation held true among women who did not consume the recommended amount of folic acid. Despite the fact that our findings are similar to those of previous studies, the results should still be interpreted cautiously due to limitations, including low precision for the highest levels of intake.
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What were the sources of funding? This work is funded by the Centers for Disease Control and Prevention (DD000697). The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
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What conflicts of interest were reported? Martha Werler owns less than $5,000 in Starbucks Corporation stock. Investigators have no other conflicts to report.
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Does the exposure (dose) need to be standardized to the SR? Yes
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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). NOAEL >/=2 cups/day 2 cups x 95 mg/cup = 190 mg
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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.  Spina bifida: NOAEL >/=190 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. ORs = <1 cup/day aOR: 0.7, 95% CI: 0.4, 1.1; 1 cup/day aOR: 0.9, 95% CI: 0.6, 1.3; >2 cups/day aOR: 0.6, 95% CI: 0.3, 1.2
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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