Document Detail

Postmarketing surveillance for human teratogenicity: a model approach.
MedLine Citation:
PMID:  11745831     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Most congenital defects associated with prenatal exposures are notable for a pattern of major and minor malformations, rather than for a single major malformation. Thus, traditional epidemiological methods are not universally effective in identifying new teratogens. The purpose of this report is to outline a complementary approach that can be used in addition to other more established methods to provide the most comprehensive evaluation of prenatal exposures with respect to teratogenicity. METHODS: We describe a multicenter prospective cohort study design involving dysmorphological assessment of liveborn infants. This design uses the Organization of Teratology Information Services, a North American network of information providers who also collaborate for research purposes. Procedures for subject selection, methods for data collection, standard criteria for outcome classification, and the approach to analysis are detailed. RESULTS: The focused cohort study design allows for evaluation of a spectrum of adverse pregnancy outcomes ranging from spontaneous abortion to functional deficit. While sample sizes are typically inadequate to identify increased risks for single major malformations, the use of dysmorphological examinations to classify structural anomalies provides the unique advantage of screening for a pattern of malformation among exposed infants. CONCLUSIONS: As the known human teratogens are generally associated with patterns of structural defects, it is only when studies of this type are used in combination with more traditional methods that we can achieve an acceptable level of confidence regarding the risk or safety of specific exposures during pregnancy.
C D Chambers; S R Braddock; G G Briggs; A Einarson; Y R Johnson; R K Miller; J E Polifka; L K Robinson; K Stepanuk; K Lyons Jones
Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  Teratology     Volume:  64     ISSN:  0040-3709     ISO Abbreviation:  Teratology     Publication Date:  2001 Nov 
Date Detail:
Created Date:  2001-12-17     Completed Date:  2002-02-25     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0153257     Medline TA:  Teratology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  252-61     Citation Subset:  IM    
Copyright Information:
Copyright 2001 Wiley-Liss, Inc.
Department of Pediatrics, University of California, San Diego, CA 92103-8446, USA.
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MeSH Terms
Abnormalities, Drug-Induced / diagnosis*
Abortion, Spontaneous
Cohort Studies
Congenital Abnormalities / etiology*
Data Collection / methods
Drug Utilization
Infant, Newborn
Pregnancy Outcome
Product Surveillance, Postmarketing
Research Design
Reg. No./Substance:

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