title: Maternal antiretroviral use during pregnancy and infant congenital anomalies: the NISDI perinatal study.
abstract: BACKGROUND
  We evaluated the association between maternal antiretrovirals (ARVs) during pregnancy and infant congenital anomalies (CAs), utilizing data from the National Institute of Child Health and Human Development International Site Development Initiative Perinatal Study.
  
  
  METHODS
  The study population consisted of first singleton pregnancies on study, > or =20 weeks gestation, among women enrolled in NISDI from Argentina and Brazil who delivered between September 2002 and October 2007. CAs were defined as any major structural or chromosomal abnormality, or a cluster of 2 or more minor abnormalities, according to the conventions of the Antiretroviral Pregnancy Registry. CAs were identified from fetal ultrasound, study visit, and death reports. Prevalence rates [number of CAs per 100 live births (LBs)] were calculated for specific ARVs, classes of ARVs, and overall exposure to ARVs.
  
  
  RESULTS
  Of 1229 women enrolled, 995 pregnancy outcomes (974 LBs) met the inclusion criteria. Of these, 60 infants (59 LBs and 1 stillbirth) had at least 1 CA. The overall prevalence of CAs (per 100 LBs) was 6.2 [95% confidence interval (CI) 4.6 to 7.7]. The prevalence of CAs after first trimester ARVs (6.2; 95% CI 3.1 to 9.3) was similar to that after second (6.8; 95% CI 4.5 to 9.0) or third trimester (4.3; 95% CI 1.5 to 7.2) exposure. The rate of CAs identified within 7 days of delivery was 2.36 (95% CI 1.4 to 3.3).
  
  
  CONCLUSIONS
  The prevalence of CAs after first trimester exposure to ARVs was similar to that after second or third trimester exposure. Continued surveillance for CAs among children exposed to ARVs during gestation is needed.
authors.affiliation: Serviço de Doenças Infecciosas e Parasitárias do HSE - Hospital dos Servidores do Estado, Rio de Janeiro, Brazil. esau@uninet.com.br
authors.forename: Esau C
authors.initials: EC
authors.lastname: Joao
authors.forename: Guilherme A
authors.initials: GA
authors.lastname: Calvet
authors.forename: Margot R
authors.initials: MR
authors.lastname: Krauss
authors.forename: Laura
authors.initials: L
authors.lastname: Freimanis Hance
authors.forename: Javier
authors.initials: J
authors.lastname: Ortiz
authors.forename: Silvina A
authors.initials: SA
authors.lastname: Ivalo
authors.forename: Russell
authors.initials: R
authors.lastname: Pierre
authors.forename: Mary
authors.initials: M
authors.lastname: Reyes
authors.forename: D
authors.initials: D
authors.lastname: Heather Watts
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Read
mesh_terms: D000014:Abnormalities, Drug-Induced; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011264:Pregnancy Trimesters
chemical_list: D019380:Anti-HIV Agents