Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial.
Chlorhexidine vaginal and infant wipes to reduce perinatal mortality and morbidity: a randomized controlled trial.
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DOI：
10.1097/aog.0b013e3181e00ff0
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发表时间：
2010-06
影响因子：
7.2
通讯作者：
Goldenberg RL
中科院分区：
文献类型：
--
作者：
Saleem S;Rouse DJ;McClure EM;Zaidi A;Reza T;Yahya Y;Memon IA;Khan NH;Memon G;Soomro N;Pasha O;Wright LL;Moore J;Goldenberg RL
败血症是发展中国家围产期死亡的主要原因。分娩过程中获得的阴道微生物发挥着重要作用。先前的研究表明，在分娩过程中用氯己定擦拭产妇阴道和新生儿可能会减少围产期感染。我们在巴基斯坦的三家医院进行了一项安慰剂对照、随机试验，使用氯己定阴道和新生儿湿巾来降低新生儿败血症和死亡率。主要研究结果是新生儿败血症或 7 天围产儿死亡率的综合结果。从 2005 年到 2008 年，5,008 名产妇及其新生儿被随机分配接受氯己定湿巾（n = 2,505）或含生理盐水安慰剂的湿巾（n = 2,503）。氯己定组和对照组的主要结局相似（3.1% vs. 3.4%；RR 0.91，95% CI 0.67，1.24），新生儿败血症或 28 天围产儿死亡率的综合发生率也相似（3.8% vs. 3.9%，RR 0.96，95% CI 0.73，1.27）。第 7 天时，洗必太组新生儿皮肤感染率较低。 （3.3% vs. 8.2%，p<0.0001）除了洗必太组 7 天住院频率较低之外，各组之间的产妇结局没有显着差异。该试验提供的证据表明，在分娩期间使用产妇洗必泰阴道湿巾和新生儿洗必泰湿巾不会降低孕产妇和围产儿死亡率或新生儿败血症。第 7 天浅表皮肤感染减少但脓毒症或死亡率没有变化的发现表明，这种差异虽然具有统计学意义，但可能并不重要。试验注册：ClinicalTrials.gov：NCT00121394
Sepsis is a leading cause of perinatal death in developing countries. Vaginal organisms acquired during labor play a significant role. Prior studies suggest that chlorhexidine wiping of the maternal vagina during labor and of the neonate may reduce peripartum infections. We performed a placebo-controlled, randomized trial of chlorhexidine vaginal and neonatal wipes to reduce neonatal sepsis and mortality in three hospitals in Pakistan. The primary study outcome was a composite of neonatal sepsis or 7-day perinatal mortality. From 2005 to 2008, 5,008 laboring women and their neonates were randomized to receive either chlorhexidine wipes (n = 2,505) or wipes with a saline placebo (n = 2,503). The primary outcome was similar in the chlorhexidine and control groups, (3.1% vs. 3.4%; RR 0.91, 95% CI 0.67, 1.24), as was the composite rate of neonatal sepsis or 28-day perinatal mortality, (3.8% vs. 3.9%, RR 0.96, 95% CI 0.73, 1.27). At day 7, the chlorhexidine group had a lower rate of neonatal skin infection. (3.3 vs. 8.2%, p<0.0001) With the exception of less frequent 7-day hospitalization in the chlorhexidine group, there were no significant differences in maternal outcomes between the groups. This trial provides evidence that the use of maternal chlorhexidine vaginal wipes during labor and neonatal chlorhexidine wipes does not reduce maternal and perinatal mortality or neonatal sepsis. The finding of reduced superficial skin infections on day 7 without change in sepsis or mortality suggests that this difference, although statistically significant, may not be of major importance. Trial Registration: Clinicaltrials.gov: NCT00121394