title: Perinatal intervention trial in Africa: effect of a birth canal cleansing intervention to prevent HIV transmission.
abstract: BACKGROUND
  Perinatal transmission of human immunodeficiency virus (HIV) type 1 contributes significantly to infant mortality. Exposure in the birth canal may account for some transmission. We examined the efficacy of a birth canal washing procedure in reducing perinatal transmission in Malawi.
  
  
  METHODS
  The infection status of infants of 3327 control women (conventional delivery procedures) was compared with that of 3637 infants of intervention-delivered women. The infants' HIV status was determined by polymerase chain reaction on dried blood spots collected at 6 and 12 weeks of age. The intervention consisted of manual cleansing of the birth canal with a cotton pad soaked in 0.25% chlorhexidine, which was done on admission in labour and every 4 h until delivery.
  
  
  RESULTS
  No adverse reactions to the intervention procedure were seen. 2094 (30%) of the enrolled women were HIV-infected, and 59% of their infants were seen in follow-up. Among 982 vaginal vertex singleton deliveries to HIV-infected women, 269 (27%) infants were infected. The intervention had no significant impact on HIV transmission rates (27% in 505 intervention women compared with 28% in 477 control women), except when membranes were ruptured more than 4 h before delivery (transmission 25% in the intervention group vs 39% in the control group).
  
  
  CONCLUSIONS
  If birth canal exposure is an important risk factor, different or additional methods to reduce the risk of perinatal HIV transmission should be tested. Alternatively, perhaps birth canal exposure is not a major contributor to perinatal infection risk.
authors.affiliation: Viral Epidemiology Branch, National Cancer Institute, Bethesda, Maryland, USA.
authors.forename: R J
authors.initials: RJ
authors.lastname: Biggar
authors.forename: P G
authors.initials: PG
authors.lastname: Miotti
authors.forename: T E
authors.initials: TE
authors.lastname: Taha
authors.forename: L
authors.initials: L
authors.lastname: Mtimavalye
authors.forename: R
authors.initials: R
authors.lastname: Broadhead
authors.forename: A
authors.initials: A
authors.lastname: Justesen
authors.forename: F
authors.initials: F
authors.lastname: Yellin
authors.forename: G
authors.initials: G
authors.lastname: Liomba
authors.forename: W
authors.initials: W
authors.lastname: Miley
authors.forename: D
authors.initials: D
authors.lastname: Waters
authors.forename: J D
authors.initials: JD
authors.lastname: Chiphangwi
authors.forename: J J
authors.initials: JJ
authors.lastname: Goedert
mesh_terms: D000328:Adult; D002710:Chlorhexidine / Q000008:administration & dosage*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission*; D015497:HIV-1; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007743:Labor, Obstetric; D008295:Malawi; D016133:Polymerase Chain Reaction; D011247:Pregnancy; D014621:Vagina / Q000187:drug effects / Q000821:virology*
chemical_list: D002710:Chlorhexidine