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4092937 
Journal Article 
The Antiretroviral Pregnancy Registry: Ten Years of Progress and Ten Years of Data 
Ross, BJ; Beckerman, K; Doi, PA; Covington, D; Tilson, H 
2006 
1 
Obstetrics and Gynecology
ISSN: 0029-7844
EISSN: 1873-233X 
DART/TER/6000665 
107 
4 Suppl 
English 
BACKGROUND: The epidemiologic approach to registration of drug-exposed pregnancies and follow-up of the infants born for possible birth defects, the so-called pregnancy registry, is an institution in American pharmacoepidemiology. OBJECTIVE: We will review the experiences of the Antiretroviral Pregnancy Registry. Points to be reviewed are: the genesis for formation of the registry; governance structures; scientific follow up protocols; monitoring, analysis, and termination plan; privacy protections; dissemination strategies; and review of the data collected to date. METHODS: The Antiretroviral Pregnancy Registry monitors prenatal exposures to antiretroviral drugs to detect increases in the risk of birth defects through a prospective exposure-registration cohort. For all defects combined, a cohort of 200 is required to detect a doubling of risk compared with Centers for Disease control and Prevention and #146;s expected prevalence, (80% power and Type I error rate 5%). For specific defects, the power varies with the population and #146;s frequency of the defect and the size of the exposed group. RESULTS: The Antiretroviral Pregnancy Registry monitors pregnancy exposures and their outcomes for 29 products for the treatment of human immunodeficiency virus (HIV) disease or prevention of maternal and #150;fetal transmission. Measured against 5,168 live births with exposure at any time during pregnancy, there were 132 outcomes with birth defects identified, a prevalence of 2.6 birth defects per 100 live births (95% confidence interval 2.1 and #150;3.0). CONCLUSION: The significance of the findings and the lessons learned over the past decade demonstrate the evolution of a successful multisponsored program. Although no major teratogenic signal has been detected, the population monitored is only sufficient to detect a 2-fold risk of relatively common defects.