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Study Title and Description

Maternal characteristics and lifestyle factors and the risk of delivering high birth weight infants.



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 characteristics and lifestyle factors and the risk of delivering high birth weight infants.
Author J Ørskou,TB Henriksen,U Kesmodel,NJ Secher,
Country
Year 2003
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 12850616
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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)? Our aim was to identify factors associated with an increased risk of giving birth to infants weighing more than 4000 g and to study whether changes in these factors could explain the increasing proportion of high birth weight infants over the last decade.
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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) Self-administered questionnaire on intake at 16 weeks gestation. The final population available for analyses included 36,265 pregnancies. For a total of 24,093 pregnancies information on all variables mentioned below was available. Caffeine intake was calculated on the basis of daily average consumption of coffee (one cup = 104 mg), tea (one cup = 46 mg), cocoa (one cup = 13 mg), and cola (one bottle = 45 mg) and was then categorized as less than 200 mg a day, 200–399 mg a day, and 400 or more mg a day. Our outcome variable was delivery of a high birth weight infant, defined as having a birth weight above 4000 g. Gestational age was calculated from early (before 21 weeks’ gestation) ultrasonographically determined. The unadjusted and adjusted associations between the potential risk factors and delivery of a high birth weight infant are presented as odds ratios with 95% confidence intervals. Potential risk factors were all considered in a multivariable logistic regression analysis. They were entered in the logistic regression model as a number of dummy variables equal to the number of categories minus one, and the mutually adjusted odds ratios are presented.
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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) High birth weight infants
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes high birth weight infant, defined as having a birth weight above 4000 g
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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? 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 Information concerning birth weight was obtained from birth registration forms, completed by the attending midwife immediately after delivery.
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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 <200, 200-399, and >/=400 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) Maternal prepregancy weight, maternal height, maternal age, parity, cigarettes per day, alcohol drinks per day, living with partner, education, gestational age
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Provide a general description of results (as reported by the authors). THE AUTHORS STATE: 1) Caffeine intake of 400 or more mg per day was associated with a reduced risk of giving birth to an infant weighing more than 4000 g. 2) Women with caffeine intake of 200 or less mg per day were at statistically significantly increased risk. HOWEVER: 1) The adjusted OR at 400 mg/day was not significant (OR = 0.87, 95% CI 0.79, 0.95) and 2) Intake <200 mg/day was used as the reference for the OR analysis, there is no actual information on the statistical significance of the <200 mg/day group
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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? THE AUTHORS STATE: Women with caffeine intake of 200 or less mg per day were at statistically significantly increased risk of giving birth to an infant weighing more than 4000 g. HOWEVER: Data supporting this conclusion are not provided.
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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.  NOAEL = >400 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. The adjusted ORs were: >/=400 mg/day (OR = 0.87, 95% CI 0.79, 0.95) and 200-399 mg/day (OR = 0.88, CI 0.81, 0.96). The <200 mg/day group was used as the reference for this analysis. Even though the authors state that there was a significant increased risk in this lowest intake group, no data or justification for this conclusion are provide. Caffeine intake was calculated on the basis of daily average consumption of coffee (one cup = 104 mg), tea (one cup = 46 mg), cocoa (one cup = 13 mg), and cola (one bottle = 45 mg).
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What is the importance of the study with respect to the adverseness of the outcome? Low
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