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Study Title and Description

Maternal caffeine intake and intrauterine growth retardation.



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 intake and intrauterine growth retardation.
Author LM Grosso,KD Rosenberg,K Belanger,AF Saftlas,B Leaderer,MB Bracken,
Country
Year 2001
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 11428387
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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)? This study estimates the effect of maternal caffeine consumption during the first and third trimesters of pregnancy on fetal growth.
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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) This study is an analysis of data collected as part of the Yale Health in Pregnancy Study (prospective cohort). All women received two questionnaires: a baseline interview, conducted before 16 weeks of gestation in the women’s home, and the postpartum interview, administered in the hospital after delivery. Women were asked whether they drank one or more cups of caffeinated coffee, tea, or soda weekly since becoming pregnant. We estimated the caffeine content per beverage by assigning 107 mg caffeine per 5-oz cup of coffee, 34 mg caffeine per 5-oz cup of tea, and 47 mg caffeine per 12-oz serving of soft drink. Average weekly consumption of chocolate drinks and chocolate foods was also assessed; consumption was not assessed monthly, however, as it was for coffee, tea, and soda, and therefore could not be calculated in the total caffeine intake. IUGR was defined as being </=10th percentile of birth weight for gestational age at birth. We used logistic regression with backward elimination of potential confounding variables.
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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) SGA/IUGR
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes IUGR was defined as being </=10th percentile of birth weight for gestational age at birth.
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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? Cohort
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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 Birth weight for all infants was obtained within 24 hours after delivery. All deliveries took place at Yale- New Haven Hospital, and standardized protocols for umbilical cord clamping, use of scales, and scale calibration were used. We calculated gestational age using direct examination of infants within 6–24 hours of delivery by study nurses trained to administer the Ballard examination. The Ballard examination estimates gestational age within 2 weeks [95% confidence interval (CI)]. Of the 2,714 infants, 159 (5.7%) did not have a Ballard examination. For these infants, we calculated gestational age using the date of the last menstrual period.
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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 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 consumption: 0, 1-150, 151-300, >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) Month 1: Adjusted for: smoking during month 1, height, antenatal weight gain, preeclampsia during index pregnancy, parity, and bleeding during the third trimester. The adjusted effect for each beverage type is also adjusted for the other two beverages. Month 7: Adjusted for: smoking during month 7, height, prepregnant weight, antenatal weight gain, preeclampsia during index pregnancy, and hypertension during index pregnancy.
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Provide a general description of results (as reported by the authors). Consumption of coffee, tea, and soda during the first month of pregnancy was not strongly associated with IUGR. Adjustment for smoking status ) during the first month of pregnancy suggested a decreasing trend in risk with increasing consumption of caffeinated beverages for nonsmokers. Caffeine consumption of >300 mg per day was associated with a 29% reduction in risk [odds ratio (OR) = 0.71; 95% CI = 0.20 –2.50], although only three exposed women were in this category. Analyses by beverage type pointed toward a protective effect of heavy coffee and soda consumption among nonsmokers (OR = 0.66; 95% CI 5 0.14 –3.12 and OR = 0.49; 95% CI 5 0.06 –3.72), respectively, but these estimates are extremely imprecise. Estimates for smokers were similar for all caffeinated beverages and generally closer to the null value. For the seventh month of pregnancy, adjusted estimates for coffee, tea, and soda consumption were below unity. The effect estimates by beverage type were generally lower than those in the crude analysis and were similar to estimates for month 1 consumption. When stratified by smoking category, there were protective effects for nonsmokers within each category of caffeine consumption, with moderate consumption (151–300 mg per day) conferring the greatest reduction in risk (OR = 0.71; 95% CI = 0.34 –1.48).
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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? Caffeine consumption during the first or seventh month of pregnancy was not markedly associated with IUGR, and the adjusted estimates were similar for smokers and nonsmokers. Caffeine estimates for consumption during the seventh month of pregnancy were lower than those for month 1. Suggestive protective effects were seen among nonsmokers for each category of caffeine intake during month 7, but those estimates were based on small numbers of exposed women and had broad confidence intervals. Women who smoked during the seventh month of pregnancy were at increased risk for IUGR at each caffeine consumption level, but this effect is likely due to confounding from increased levels of smoking in higher caffeine users that could not be fully controlled because the data were sparse. This study provides evidence that antenatal caffeine consumption has no adverse effect on fetal growth.
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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.  Month 1: Adjusted ORs for 1-150, 151-300, >300 mg/day compared to reference were 1.21 [CI = 0.86-1.72], 0.95 [CI = 0.53-1.69], and 0.91 [CI = 0.44-1.90], respectively. While the authors do not state such, a NOAEL of 300 mg/day could be concluded. Month 7: Adjusted ORs for 1-150, 151-300, >300 mg/day compared to reference were 0.78 [CI = 0.55-1.09], 0.81 [CI = 00.46-1.44], and 1.00 [CI = 0.37-2.70], respectively. While the authors do not state such, a NOAEL of 300 mg/day could be concluded
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. Estimated the caffeine content per beverage by assigning 107 mg caffeine per 5-oz cup of coffee, 34 mg caffeine per 5-oz cup of tea, and 47 mg caffeine per 12-oz serving of soft drink
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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