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

@article{citeulike:6031151, abstract = {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.}, author = {Cutland, Clare L. and Madhi, Shabir A. and Zell, Elizabeth R. and Kuwanda, Locadiah and Laque, Martin and Groome, Michelle and Gorwitz, Rachel and Thigpen, Michael C. and Patel, Roopal and Velaphi, Sithembiso C. and Adrian, Peter and Klugman, Keith and Schuchat, Anne and Schrag, Stephanie J. and {the PoPS Trial Team}}, citeulike-article-id = {6031151}, citeulike-linkout-0 = {http://dx.doi.org/10.1016/S0140-6736(09)61339-8}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/19846212}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=19846212}, day = {19}, doi = {10.1016/S0140-6736(09)61339-8}, issn = {1474-547X}, journal = {Lancet}, keywords = {chlorhexidine, sepsis, vertical\_transmission}, month = {October}, posted-at = {2009-10-29 04:29:32}, priority = {2}, title = {Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial.}, url = {http://dx.doi.org/10.1016/S0140-6736(09)61339-8}, year = {2009} }

TY - JOUR ID - citeulike:6031151 L3 - citeulike-article-id:6031151 N2 - 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. JF - Lancet SN - 1474-547X TI - Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial. KW - chlorhexidine KW - sepsis KW - vertical_transmission AU - Cutland, Clare AU - Madhi, Shabir AU - Zell, Elizabeth AU - Kuwanda, Locadiah AU - Laque, Martin AU - Groome, Michelle AU - Gorwitz, Rachel AU - Thigpen, Michael AU - Patel, Roopal AU - Velaphi, Sithembiso AU - Adrian, Peter AU - Klugman, Keith AU - Schuchat, Anne AU - Schrag, Stephanie PY - 2009/10/19/ UR - http://dx.doi.org/10.1016/S0140-6736(09)61339-8 ER -