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Study Title and Description

Maternal periconceptional factors affect the risk of spina bifida-affected pregnancies: an Italian case-control study.



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 periconceptional factors affect the risk of spina bifida-affected pregnancies: an Italian case-control study.
Author P De Marco,E Merello,MG Calevo,S Mascelli,D Pastorino,L Crocetti,P De Biasio,G Piatelli,A Cama,V Capra,
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 21207040
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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)? Neural tube defects, including spina bifida and anencephaly, are the second most common birth defects with an incidence in Italy of 0.4–1/1,000. Information on factors playing a role in the pathogenesis of spina bifida is based on populations with different exposures, lifestyle, social and cultural habits compared to Italian people. Our objective was to fill this gap by using data from a case– control interview study carried out at the G. Gaslini Children’s Hospital, Genoa, from 2000 to 2008
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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 case–control study was conducted between March 2000 and January 2008 at the G. Gaslini Institute (IGG) in Genoa, the largest children’s hospital in Italy. We selected mothers who met the following inclusion criteria: (1) they were white Caucasian Italians, (2) they gave information within 24 months after the delivery of the index pregnancy, and (3) they had a child with non-syndromic open or closed spinal dysraphism. Information on the child’s diagnosis was obtained from the clinical record. Control mothers were enrolled prospectively in the same period as the cases, among Caucasian mothers who were admitted to the IGG for miscellaneous illnesses of their child. Inclusion criterion was no family history of birth defects. For control mothers whose children were born at IGG (64%), eligibility was confirmed by checking the birth registration forms. Controls were matched for age at delivery (±1–2 years), sex of index child, and geographical residence area. The interviewer solicited information on all relevant exposure. A pre-test of the questionnaire identified patient concerns regarding the purpose of the study. Revisions to the questionnaire were made based on these problems and concerns. The same structured questionnaire was administered to both cases and controls by two trained interviewers. Interviews were collected during average of 20 months for NTD mothers and 18 months for control mothers after the date of delivery. To assess caffeine consumption, women were asked to report the number of coffee cups (more or less than three cups/day). Univariate analysis was carried out to determine which of the various potential risk factors in the case population were significantly associated with the risk of spina bifida. Logistic regression analyses were used for each variable, and the results are reported as odds ratio (OR) with their 95% confidence interval (CI). Multivariate analysis was then performed.
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How many outcome-specific endpoints are evaluated?
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) NTD
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes The proband’s diagnosis was the following: open spinal dysraphisms (myelomeningocele, 49.5%) and closed spinal dysraphisms (51.5%).
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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 Information on the child’s diagnosis was obtained from the clinical record
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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
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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: 0, <3, >3
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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) The variables included in the initial model were educational level, birth order, maternal age, smoking habits, medium and high caffeine intake, alcohol intake, fruit and vegetable consumption, diet, folic acid supplementation, emotional stress, and residency near waste sites.
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Provide a general description of results (as reported by the authors). In the univariate model, the strongest association was observed for high (more than three cups per day) caffeine intake (OR=7.78; 95% CI, 4.02–15.05); the multivariate model revealed that one of the main determinants for spina bifida risk was high caffeine intake (OR=10.82; 95% CI, 3.78–31).
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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? P for trend = 0.0001
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What were the author's conclusions? In our study, multivariate analysis showed that high caffeine intake (≥300 mg/day equivalent to more than three cups per day) was associated with NTD risk. Taken together, lack of folate supplementation, high caffeine and alcohol intake, and a diet with poor content of fruit and vegetables suggest a common underlying mechanism, i.e., a disturbed folate/homocysteine metabolism.
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What were the sources of funding? None reported
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What conflicts of interest were reported? The authors have no conflicts of interest 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). LOAEL = >3 cups/day 3 cups/day x 95 mg/cup = 285 mg/day
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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.  NTD: LOAEL = >285 mg/day
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot.
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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