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

Background About 500000 sepsis-related deaths per year arise in the first 3 days of life. On the basis of results non-randomised studies, use of vaginal chlorhexidine wipes during labour has been proposed as an intervention the prevention of early-onset neonatal sepsis in developing countries. We therefore assessed the efficacy 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 chlorhexidine vaginal wipes or external genitalia water wipes during active labour, and their 8129 newborn were assigned to full-body (intervention group) or foot (control group) washes with chlorhexidine at birth, In a subset of mothers (n=5144), we gathered maternal lower vaginal swabs and neonatal skin swabs after delivery assess colonisation with potentially pathogenic bacteria. Primary outcomes were neonatal sepsis in the first 3 days life and vertical transmission of group B streptococcus. Analysis was by intention to treat. The trial is registered ClinicalTrials.gov, number NCT00136370. Findings Rates of neonatal sepsis did not differ between the groups (chlorhexidine 141 [3%] of 4072 vs control 148 of 4057; p=0.6518). Rates of colonisation with group B streptococcus in newborn babies born to mothers in chlorhexidine (217 [54%] of 401) and control groups (234 [55%] of 429] did not differ (efficacy 95% CI -9.5 to 7.9). Interpretation Because chlorhexidine intravaginal and neonatal wipes did not prevent neonatal sepsis or the acquisition of potentially pathogenic bacteria among neonates, we need other interventions to reduce childhood mortality.