Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial
Chlorhexidine maternal-vaginal and neonate body wipes in sepsis and vertical transmission of pathogenic bacteria in South Africa: a randomised, controlled trial
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DOI：
10.1016/s0140-6736(09)61339-8
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发表时间：
2009-12-05
期刊：
影响因子：
168.9
通讯作者：
Schrag, Stephanie J.
中科院分区：
文献类型：
--
作者：
Cutland, Clare L.;Madhi, Shabir A.;Schrag, Stephanie J.
背景每年约有500000例败血症相关死亡发生在生命的前3天。根据非随机研究的结果，在发展中国家，分娩期间使用阴道洗必泰湿巾已被提议作为预防早发性新生儿败血症的干预措施。因此，我们评估了氯己定在早发性新生儿败血症和B组链球菌垂直传播中的疗效。（年龄12-51岁）被随机分配到1：1例顺产时用洗必泰阴道拭子或外生殖器水拭子擦拭，并将其8129例新生儿分配为全身（干预组）或足（对照组）在出生时用洗必泰清洗，在母亲的一个子集中（n=5144），我们在分娩后收集了母亲的下阴道拭子和新生儿的皮肤拭子，以评估潜在致病菌的定植。主要结局为出生后3天内的新生儿败血症和B组链球菌的垂直传播。试验注册于ClinicalTrials.gov，编号NCT 00136370。结果两组新生儿败血症的发生率没有差异（4072例中氯己定组141例[3%]，对照组4057例中148例; p=0.6518）。使用洗必泰的母亲所生新生儿中B群链球菌的定植率（217/401 [54%]）和对照组（429例中的234例[55%]没有差异（疗效95%CI-9. 5至7. 9）。解释由于氯己定阴道内和新生儿湿巾不能预防新生儿败血症或新生儿中潜在致病菌的获得，我们需要其他干预措施来降低儿童死亡率。
Background About 500000 sepsis-related deaths per year arise in the first 3 days of life. On the basis of results non-randomised studies, use of vaginal chlorhexidine wipes during labour has been proposed as an intervention the prevention of early-onset neonatal sepsis in developing countries. We therefore assessed the efficacy 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 chlorhexidine vaginal wipes or external genitalia water wipes during active labour, and their 8129 newborn were assigned to full-body (intervention group) or foot (control group) washes with chlorhexidine at birth, In a subset of mothers (n=5144), we gathered maternal lower vaginal swabs and neonatal skin swabs after delivery assess colonisation with potentially pathogenic bacteria. Primary outcomes were neonatal sepsis in the first 3 days life and vertical transmission of group B streptococcus. Analysis was by intention to treat. The trial is registered ClinicalTrials.gov, number NCT00136370.Findings Rates of neonatal sepsis did not differ between the groups (chlorhexidine 141 [3%] of 4072 vs control 148 of 4057; p=0.6518). Rates of colonisation with group B streptococcus in newborn babies born to mothers in chlorhexidine (217 [54%] of 401) and control groups (234 [55%] of 429] did not differ (efficacy 95% CI -9.5 to 7.9).Interpretation Because chlorhexidine intravaginal and neonatal wipes did not prevent neonatal sepsis or the acquisition of potentially pathogenic bacteria among neonates, we need other interventions to reduce childhood mortality.