Use of microbicide-soaked vaginal and infant wipes does not prevent neonatal sepsis

October 19, 2009

Use of vaginal and infant wipes soaked with the microbicide chlorhexidene does not prevent neonatal sepsis, or prevent mother-infant transmission of disease-causing bacteria. Thus other interventions are needed to target child mortality, concludes an Article published Online First (www.thelancet.com) and in an upcoming edition of The Lancet. But an accompanying Comment argues that research on the wipes should not be abandoned and that they work in high risk settings.

About 900 000 sepsis-associated neonatal deaths per year arise in developing countries, mainly in the first week of life. Early-onset sepsis poses unique opportunities for prevention because of intrapartum, vertical transmission of bacteria to newborn babies. For example, widespread use of targeted prophylaxis with intrapartum antibiotics in the USA coincided with a 70% reduction in early-onset group B streptococcal disease. Logistical and resource limitations, however, prevent use of intrapartum antibiotics in developing countries.In this randomised controlled trial, the authors (led by Dr Clare L Cutland, Vaccine Preventable Diseases and Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, South Africa) assessed the efficacy of intrapartum and neonatal chlorhexidine coated-wipes in reducing early-onset neonatal sepsis and vertical transmission of group B streptococcus.

The trial took place in Soweto, South Africa, and 8,011 women (aged 12󈞟 years) were randomly assigned in a 1:1 ratio to chlorhexidine vaginal wipes or external genitalia water wipes during active labour, and their 8,129 newborn babies were assigned to chlorhexidine full-body (intervention group) or foot (control group) washes with chlorhexidine at birth, respectively. In a subset of mothers (n=5144 lower vaginal swabs and neonatal skin swabs were gathered 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.

The researchers found that rates of neonatal sepsis did not differ between the groups (chlorhexidine 3% vs 4%). Rates of colonisation with group B streptococcus in newborn babies born to mothers in the chlorhexidine (54%) and control groups (55%) did not differ.

The authors say: "Use of maternal and neonatal chlorhexidine wipes did not prevent the occurrence of early-onset sepsis. This absence of benefit was corroborated by the lack of effect on vertical transmission of the main sepsis-causing pathogens, and on serious maternal post-partum sepsis."

They conclude: "Although several trials have raised hopes that chlorhexidine vaginal and neonatal cleansing would be beneficial in saving the lives of newborn babies, the results from our trial suggest that use of chlorhexidine wipes is unlikely to reduce neonatal mortality from vertically acquired sepsis. Other neonatal interventions are needed to achieve the Millennium Developmental Goal of reduction in childhood mortality."

In an accompanying Comment, Dr Luke C Mullany, John Hopkins Bloomberg School of Public Health, Baltimore, MD, USA and Robert J Biggar, State Serum Institute, Copenhagen, Denmark and International Agency for Research on Cancer, Lyon, France, say: "We do not believe that further pursuit of this low cost and simple-to-deliver intervention should be abandoned. Nearly 4 million newborn babies die every year and low-cost interventions that are simple to deliver in resource-constrained settings are urgently needed. When vaginal and neonatal skin cleansing with chlorhexidine has been examined in high-risk settings, the dual intervention has reduced mortality. We strongly urge further studies of the role of chlorhexidine use in low-resource delivery rooms and community settings."
-end-
Dr Clare L Cutland, Vaccine Preventable Diseases and Respiratory and Meningeal Pathogens Research Unit, University of Witwatersrand, South Africa. T)+27-11-9899891 E) cutlandc@hivsa.com

Dr Luke C Mullany, John Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. T) +1 410-502-2626 E) lmullany@jhsph.edu

For full Article and Comment, see: http://press.thelancet.com/sepsiswipes.pdf

Lancet

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