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Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project

Pregnancy Clinical Trial

Official title:
OTIS Autoimmune Diseases in Pregnancy Project

Clinical Trial Summary

The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.

Clinical Trial Description

This pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and health care providers throughout North America. Participants in the first two cohorts are recruited concurrently from callers to OTIS centers, from health care providers and through direct to consumer marketing efforts. The source of historical controls is archived data on pregnancies that have been followed through the California Teratogen Information Service's Clinical Research Program located at the University of California San Diego. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00116272
Study type Observational
Source Amgen
Contact
Status Completed
Phase
Start date April 2005
Completion date June 2014
View Details
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