title: Birth defects in a cohort of infants born to HIV-infected women in Spain, 2000-2009.
abstract: BACKGROUND
  Antiretroviral therapy (ART) in pregnancy has resulted in a marked impact on reducing the risk of mother-to-child transmission (MCT) of HIV. However the safety of in utero ART exposure in newborns remains a concern.
  
  
  METHODS
  A multicenter prospective observational study of HIV-infected mother and their infants was performed in Madrid, Spain, from 2000 to 2009. Children had regular visits with clinical examination according to protocol until the age of 24 months. An abdominal ultrasound and an echocardiogram were scheduled during follow up. Birth defects (BDs) were registered according to European Surveillance of Congenital Anomalies (EUROCAT).
  
  
  RESULTS
  A total of 897 live births from 872 mothers were included. Overall the birth defects prevalence observed was 6.9% (95% CI 5.4-9.1).The most commonly reported birth defects types were in genital organs and urinary system (19 cases, 30.6%) and cardiovascular system (17 cases, 27.4%). There was no increased risk for infants exposed in the first trimester to ARVs compared with unexposed infants. No significant associations were observed between exposure to any individual antiretroviral agent during pregnancy and birth defects
  
  
  CONCLUSIONS
  A higher prevalence of BDs was observed, higher than previously reported. In utero exposure to ART was not proved to be a major risk factor of birth defects in infants. However the relatively small number of patients is a major limitation of this study.
authors: Luis M
authors: LM
authors: Prieto
authors: María Isabel
authors: MI
authors: González-Tomé
authors: Eloy
authors: E
authors: Muñoz
authors: María
authors: M
authors: Fernández-Ibieta
authors: Beatriz
authors: B
authors: Soto
authors: Ana
authors: A
authors: Álvarez
authors: Maria Luisa
authors: ML
authors: Navarro
authors: Miguel Ángel
authors: MÁ
authors: Roa
authors: José
authors: J
authors: Beceiro
authors: María Isabel
authors: MI
authors: de José
authors: Iciar
authors: I
authors: Olabarrieta
authors: David
authors: D
authors: Lora
authors: José Tomás
authors: JT
authors: Ramos
mesh_terms: D044966:Anti-Retroviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015331:Cohort Studies; D000013:Congenital Abnormalities / Q000453:epidemiology*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control / Q000635:transmission*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D015995:Prevalence; D011446:Prospective Studies; D012307:Risk Factors; D013030:Spain / Q000453:epidemiology
chemical_list: D044966:Anti-Retroviral Agents