title: Assessment of birth defects according to maternal therapy among infants in the Women and Infants Transmission Study.
abstract: BACKGROUND
  To evaluate rate and types of birth defects according to timing of antiretroviral exposure among babies born to HIV-infected women.
  
  
  METHODS
  Anomalies identified during the prenatal, neonatal, or follow-up period were classified using criteria of the Antiretroviral Pregnancy Registry. Antiretroviral use was classified as none, second or third trimester only, or first trimester.
  
  
  RESULTS
  From January 1, 1990 through June 30, 2004, 2527 live births (LBs) occurred to 2353 women. Defects were identified in 90 babies for a rate of 3.56 defects per 100 LBs. The rate of defects was 3.19 per 100 LBs (24 of 752 LBs) with first-trimester antiretroviral exposure, 3.54 per 100 LBs (41 of 1158 LBs) with exposure later in pregnancy, and 4.05 of 100 LBs (25 of 617 LBs) with no antiretroviral use. Only genital abnormalities, specifically hypospadias, were significantly increased among babies born to women with first-trimester exposure to antiretrovirals (7 of 382 male LBs) compared with the 2 other groups (2 of 892 male LBs; P = 0.007). On logistic regression, use of zidovudine in the first trimester was associated with hypospadias (adjusted odds ratio = 10.68, 95% confidence interval: 2.11 to 54.13; P = 0.004).
  
  
  CONCLUSIONS
  In general, data were reassuring, although the frequency of exposure to newer agents was limited. The increased risk of hypospadias after first-trimester exposure must be explored, because this association has not been detected previously.
authors.affiliation: Pediatric, Adolescent, and Maternal AIDS Branch, Center for Research on Mothers and Infants, National Institute of Child Health and Human Development/NIH, 6100 Executive Boulevard, Bethesda, MD 20892, USA. heather.watts@nih.hhs.gov
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
authors.forename: Daner
authors.initials: D
authors.lastname: Li
authors.forename: Ed
authors.initials: E
authors.lastname: Handelsman
authors.forename: Hugh
authors.initials: H
authors.lastname: Tilson
authors.forename: Mary
authors.initials: M
authors.lastname: Paul
authors.forename: Marc
authors.initials: M
authors.lastname: Foca
authors.forename: Mark
authors.initials: M
authors.lastname: Vajaranant
authors.forename: Clemente
authors.initials: C
authors.lastname: Diaz
authors.forename: Ruth
authors.initials: R
authors.lastname: Tuomala
authors.forename: Bruce
authors.initials: B
authors.lastname: Thompson
mesh_terms: D000014:Abnormalities, Drug-Induced; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*
chemical_list: D019380:Anti-HIV Agents