O223 Antiretroviral Pregnancy Registry (APR) at 10,000 prospective reports
© Beckerman et al; licensee BioMed Central Ltd. 2008
Published: 10 November 2008
Prospective data on neonatal outcome following in utero exposure to antirerovirals (ARVs) are essential components of safety monitoring of these life-saving therapies. Toward this end, APR was created in 1989 and is now one of the largest ongoing pregnancy registries in the world.
APR is an international registry that uses a prospective exposure-registration cohort design to monitor potential birth defects following in utero ARV exposure. Health care providers voluntarily enroll exposed pregnant women, then provide follow-up neonatal data. We analyzed APR data for their ability to detect, at 80% power with Type I error rate of 5%, potential increases in birth defect prevalence following fetal 1st trimester (TRI) exposure (when organogenesis occurs), vs. 2nd and 3rd TRI exposures.
Summary of results
LB Prevalence (95%CI)
Two drugs met the threshold for evaluation and further monitoring: zidovudine was associated with an increased risk of hypospadius , and a higher than expected defect prevalence following didanosine exposure that has no apparent pattern and is not statistically significant .
In summary, prospectively collected APR data have not detected an overall increase in birth defects following in utero ARV exposure during organogenesis. We continue to follow two trends that do not reach statistical significance.
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- Antiretroviral Pregnancy Registry International Interim Report for 1 January 1989 through 31 January 2008. 2008, Wilmington, NC: Registry Coordinating Center, [http://www.APRegistry.com]
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