Clinical review procedures for the Antiretroviral Pregnancy Registry

Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):529-36. doi: 10.1002/pds.971.


The Antiretroviral Pregnancy Registry (APR) is an international pregnancy exposure registry designed to monitor prenatal antiretroviral medication exposures and detect any potential increase in the risk of major birth defects. The APR process imitates that of the Metropolitan Atlanta Congenital Defects Program (MACDP) modified to account for the differences in surveillance systems. The APR case definition attempts to separate prenatal and postnatal medication exposure, includes cases with multiple conditional defects only and collects cases diagnosed at later ages. Possible temporal association between defect pathogenesis and antiretroviral medication exposure includes a way to identify cases with known etiology--such as familial genetic conditions--and those with currently ambiguous pathogenesis--like hemangiomata and club feet. The APR also accounts for confounding factors like maternal alcohol use. Some defect reports automatically generate questions back to the reporter asking for more information. The APR incorporates procedures for managing and recording some of the more inconsistently reported malformations, such as microcephaly.

MeSH terms

  • Abnormalities, Drug-Induced / classification*
  • Anti-Retroviral Agents / adverse effects*
  • Female
  • Humans
  • Pregnancy
  • Prenatal Exposure Delayed Effects*
  • Registries*


  • Anti-Retroviral Agents