Members of the Organization of Teratology Information Services Research Committee.
Postmarketing surveillance for human teratogenicity: A model approach†
Article first published online: 11 OCT 2001
Copyright © 2001 Wiley-Liss, Inc.
Volume 64, Issue 5, pages 252–261, November 2001
How to Cite
Chambers, C. D., Braddock, S. R., Briggs, G. G., Einarson, A., Johnson, Y. R., Miller, R. K., Polifka, J. E., Robinson, L. K., Stepanuk, K. and Lyons Jones, K. (2001), Postmarketing surveillance for human teratogenicity: A model approach. Teratology, 64: 252–261. doi: 10.1002/tera.1071
- Issue published online: 11 OCT 2001
- Article first published online: 11 OCT 2001
- Manuscript Accepted: 5 JUL 2001
- Manuscript Received: 22 DEC 2000
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.
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.
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.
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. Teratology 64:252–261, 2001. © 2001 Wiley-Liss, Inc.