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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial
The Lancet, Volume 374, No. 9705, Year 2009
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Description
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. 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. © 2009 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Cutland, Clare Louise
South Africa, Pretoria
National Research Foundation
Madhi, Shabir A.
South Africa, Pretoria
National Research Foundation
Zell, Elizabeth R.
United States, Atlanta
Centers for Disease Control and Prevention
Kuwanda, Locadiah
South Africa, Pretoria
National Research Foundation
Laque, Martin
South Africa, Pretoria
National Research Foundation
Groome, Michelle J.
South Africa, Pretoria
National Research Foundation
Gorwitz, Rachel
United States, Atlanta
Centers for Disease Control and Prevention
Thigpen, Michael C.
United States, Atlanta
Centers for Disease Control and Prevention
Patel, Roopal
United States, Atlanta
Centers for Disease Control and Prevention
Velaphi, Sithembiso Christopher
South Africa, Johannesburg
Chris Hani Baragwanath Hospital
Adrian, Peter V.
South Africa, Pretoria
National Research Foundation
Klugman, K. P.
South Africa, Pretoria
National Research Foundation
United States, Atlanta
Rollins School of Public Health
Schuchat, Anne
United States, Atlanta
Centers for Disease Control and Prevention
Schrag, Stephanie J.
United States, Atlanta
Centers for Disease Control and Prevention
Statistics
Citations: 98
Authors: 14
Affiliations: 4
Identifiers
Doi:
10.1016/S0140-6736(09)61339-8
ISSN:
01406736
Research Areas
Environmental
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
South Africa
Participants Gender
Female