Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial

Lancet. 2009 Dec 5;374(9705):1909-16. doi: 10.1016/S0140-6736(09)61339-8. Epub 2009 Oct 19.


Background: About 500,000 sepsis-related deaths per year arise in the first 3 days of life. On the basis of results from non-randomised studies, use of vaginal chlorhexidine wipes during labour has been proposed as an intervention for the prevention of early-onset neonatal sepsis in developing countries. We therefore assessed the efficacy of chlorhexidine in early-onset neonatal sepsis and vertical transmission of group B streptococcus.

Methods: In a trial in Soweto, South Africa, 8011 women (aged 12-51 years) were randomly assigned in a 1:1 ratio to chlorhexidine vaginal wipes or external genitalia water wipes during active labour, and their 8129 newborn babies were assigned to full-body (intervention group) or foot (control group) washes with chlorhexidine at birth, respectively. In a subset of mothers (n=5144), we gathered maternal lower vaginal swabs and neonatal skin swabs after delivery to assess colonisation with potentially pathogenic bacteria. Primary outcomes were neonatal sepsis in the first 3 days of life and vertical transmission of group B streptococcus. Analysis was by intention to treat. The trial is registered with, number NCT00136370.

Findings: Rates of neonatal sepsis did not differ between the groups (chlorhexidine 141 [3%] of 4072 vs control 148 [4%] of 4057; p=0.6518). Rates of colonisation with group B streptococcus in newborn babies born to mothers in the chlorhexidine (217 [54%] of 401) and control groups (234 [55%] of 429] did not differ (efficacy -0.05%, 95% CI -9.5 to 7.9).

Interpretation: Because chlorhexidine intravaginal and neonatal wipes did not prevent neonatal sepsis or the vertical acquisition of potentially pathogenic bacteria among neonates, we need other interventions to reduce childhood mortality.

Funding: US Agency for International Development, National Vaccine Program Office and Centers for Disease Control's Antimicrobial Resistance Working Group, and Bill & Melinda Gates Foundation.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Anti-Infective Agents, Local / administration & dosage*
  • Bacteria / isolation & purification
  • Bacterial Infections / prevention & control*
  • Chlorhexidine / administration & dosage*
  • Developing Countries*
  • Female
  • Humans
  • Infant Care
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical / prevention & control*
  • Labor, Obstetric*
  • Pregnancy
  • Pregnancy Complications, Infectious / microbiology
  • Skin / microbiology*
  • South Africa
  • Streptococcal Infections / prevention & control
  • Streptococcus agalactiae
  • Vagina / microbiology*
  • Young Adult


  • Anti-Infective Agents, Local
  • Chlorhexidine

Associated data