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Study Title and Description

Effect of coffee intake on blood flow and maternal stress during the third trimester 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 Effect of coffee intake on blood flow and maternal stress during the third trimester of pregnancy.
Author H Tsubouchi,K Shimoya,S Hayashi,M Toda,K Morimoto,Y Murata,
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 16242134
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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)? Although coffee consumption is widely used for refreshment and relaxation, its effect on the stress levels of pregnant women is still unknown. The aim of the present study was to investigate the effects of an ordinary dose of coffee on the maternal saliva cortisol levels and the placental and fetal blood circulation during the third trimester of pregnancy
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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 study volunteers (10 pregnant in 3rd trimester, 14 non-pregnant) were nonsmokers accustomed to drinking 1 to 3 cups of coffee per day, with no history of taking any drugs or medications. All participants took 1 cup of coffee containing 100 mg of caffeine. A Doppler examination was performed in the pregnant women before and after coffee consumption to analyze blood flow in the maternal uterine artery (UtA), umbilical artery (UA), and fetal middle cerebral artery (MCA). Salivary samples were collected from the 10 pregnant women and 14 nonpregnant controls just before coffee intake and 30 min later. Salivary cortisol levels and chromogranin A titers were determined. Saliva cortisol levels were determined with a commercial enzyme immunoassay kit (Ciron, Tokyo, Japan). Salivary CgA levels were determined by enzymelinked immunosorbent assay (ELISA) using a previously described method. Data are given as mean +/- SEM.
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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) Markers of maternal stress: maternal and fetal blood flow, salivary cortisol, salivary chromogranin A (CgA)
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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
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Physiological Physiological
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Other
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What is the study design? Controlled Trial
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Randomized or Non-Randomized? NCT
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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 All blood flow measurements were taken by the same investigator using the realtime Toshiba ultrasound systems SSA-270A or SSA- 380A (Toshiba Medical Systems, Tokyo, Japan) and a 3.75-Mhz convex array sector transducer. The resistance index (RI) values were calculated to demonstrate the effect of coffee intake on maternal and fetal blood flow. Saliva cortisol levels were determined with a commercial enzyme immunoassay kit (Ciron, Tokyo, Japan). Salivary CgA levels were determined by enzymelinked immunosorbent assay (ELISA) using a previously described method.
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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 Measured
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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.) No comparison - all subjects received same dose (effects in non-pregnant women were used to compare normal responses)
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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) None stated
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Provide a general description of results (as reported by the authors). The Doppler blood flow analysis revealed that coffee intake had no effect on maternal or fetal blood flow in the third trimester. Salivary cortisol levels were higher in the pregnant women (0.41 +/- 0.07 g/dL) than in the controls (0.29+/- 0.06 g/dL), before coffee intake, but not significantly ( P =.21). After coffee intake, the cortisol levels were 0.33 +/- 0.07 g/dL in the saliva of the pregnant women and 0.27 +/- 0.05 g/dL in the saliva of the controls. Coffee intake did not affect salivary cortisol levels in the controls whereas it reduced these levels in the pregnant women ( P < .05).Salivary CgA levels in the pregnant women and controls were 0.78 +/- 0.14 and 0.73 +/- 0.13 pmol/mg before coffee intake. Coffee intake sharply increased CgA levels in the controls (1.76 +/- 0.46 pmol/mg) (P < .05), which is an adverse effect. In the pregnant women the mean salivary CgA level was only moderately increased after coffee intake (1.03 +/- 0.39 pmol/mg), which may have a relaxing effect on psychomotor stress.
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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? These findings show that the relaxing effect of coffee is stronger in pregnant than in nonpregnant women. Since several studies have demonstrated that maternal stress had adverse effects on pregnancy outcome, a moderate consumption of coffee might have the good effect of decreasing stress levels in pregnant women.
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What were the sources of funding? This work was supported, in part, by Grants-in-Aid for Scientific Research (Nos. 15209054, 15591746 and 16390476) from the Ministry of Education, Science, and Culture of Japan (Tokyo, Japan) and All Japan Coffee Association (Tokyo, Japan).
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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 = 100 mg (one single dose) caffeine
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. No adverse effect on maternal or fetal blood flow, or on cortisol or CgA levels; protective effects (relaxing) were noted for salivary cortisol and CgA levels
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What is the importance of the study with respect to the adverseness of the outcome? Important
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Baseline Characteristics
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