Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial.
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 ClinicalTrials.gov, number NCT00136370.


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
US Agency for International Development, National Vaccine Program Office and Centers for Disease Control's Antimicrobial Resistance Working Group, and Bill & Melinda Gates Foundation.
Cutland
Clare L
CL
Department of Science and Technology/National Research Foundation, Vaccine Preventable Diseases and Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, University of Witwatersrand, Soweto, South Africa. cutlandc@hivsa.com
Madhi
Shabir A
SA
Zell
Elizabeth R
ER
Kuwanda
Locadiah
L
Laque
Martin
M
Groome
Michelle
M
Gorwitz
Rachel
R
Thigpen
Michael C
MC
Patel
Roopal
R
Velaphi
Sithembiso C
SC
Adrian
Peter
P
Klugman
Keith
K
Schuchat
Anne
A
Schrag
Stephanie J
SJ
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D001419:Bacteria / Q000302:isolation & purification; D001424:Bacterial Infections / Q000517:prevention & control*; D002710:Chlorhexidine / Q000008:administration & dosage*; D003906:Developing Countries; D005260:Female; D006801:Humans; D007224:Infant Care; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007743:Labor, Obstetric; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000382:microbiology; D012867:Skin / Q000382:microbiology*; D013019:South Africa; D013290:Streptococcal Infections / Q000517:prevention & control; D013292:Streptococcus agalactiae; D014621:Vagina / Q000382:microbiology*; D055815:Young Adult
D000891:Anti-Infective Agents, Local; D002710:Chlorhexidine