Neonatal Sepsis: Is The Use Of Microbicide-Soaked Vaginal And Infant Wipes Useful For Prevention?

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Main Category: Pediatrics / Children's Health
Also Included In: Pregnancy / Obstetrics;  Infectious Diseases / Bacteria / Viruses
Article Date: 20 Oct 2009 - 0:00 PST

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An article published Online First and in a future edition of The Lancet reports that use of vaginal and infant wipes soaked with the microbicide chlorhexidene does not prevent neonatal sepsis. In addition, it does not prevent mother-infant transmission of disease-causing bacteria. As a result, other interventions are needed to target child mortality. However, an associated comment argues that research on the wipes should not be abandoned and that they work in high risk settings.

It is estimated that every year, about 900,000 sepsis-associated neonatal deaths occur 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 instance in the USA, widespread use of targeted prophylaxis with intrapartum antibiotics coincided with a 70 percent reduction in early-onset group B streptococcal disease. However, logistical and resource limitations avoid the use of intrapartum antibiotics in developing countries. The authors of this randomized trial are led by Dr Clare L Cutland, Vaccine Preventable Diseases and Respiratory and Meningeal Pathogens Research Unit, University of the Witwatersrand, South Africa. They evaluated the efficacy of intrapartum and neonatal chlorhexidine coated-wipes in reducing early-onset neonatal sepsis and vertical transmission of group B streptococcus.

A total of 8,011 women aged 12 to 51 years were involved in the trial in Soweto, South Africa. They were randomly assigned in a 1:1 ratio to chlorhexidine vaginal wipes or external genitalia water wipes during active labour. 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 division of mothers (n=5,144) lower vaginal swabs and neonatal skin swabs were gathered after delivery in order to assess colonisation with potentially pathogenic bacteria. Primary outcomes were neonatal sepsis in the first three days of life and vertical transmission of group B streptococcus.

The findings indicated that the rates of neonatal sepsis did not differ between the groups (chlorhexidine 3 percent compared to 4 percent in control group). The rates of colonisation with group B streptococcus in newborn babies born to mothers in the chlorhexidine (54 percent) and control groups (55 percent) were similar.

The authors explain: "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 write in conclusion: "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 a supplementary 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, remark: "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."

"Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial"
Clare L Cutland, Shabir A Madhi, Elizabeth R Zell, Locadiah Kuwanda, Martin Laque, Michelle Groome, Rachel Gorwitz, Michael C Thigpen, Roopal Patel, Sithembiso C Velaphi, Peter Adrian, Keith Klugman, Anne Schuchat, Stephanie J Schrag, and the PoPS Trial Team
DOI: 10.1016/S0140-6736(09)61339-8
The Lancet

Written by Stephanie Brunner (B.A.)
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