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CHLORHEXIDINE IRRIGATION TO PREVENT INFECTION

CHLORHEXIDINE IRRIGATION TO PREVENT INFECTION
氯己定冲洗以预防感染
批准号:
6138821
负责人:
DWIGHT J ROUSE
金额:
$19.5万
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-01-01 至 2001-12-31

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中文摘要
翻译
临床上明显的胎盘、胎膜或子宫感染 分娩期间(绒毛膜炎)并发症从1%到11%的怀孕。 分娩后子宫感染(子宫内膜炎)的发生率各不相同 从阴道分娩后的1%-3%到剖宫产后的15-20%。 绒毛膜炎是公认的菌血症和脓毒性的危险因素 休克,并与几倍的风险增加, 剖腹产在以下情况下接受剖宫产的妇女 绒毛膜炎是在严重的骨盆和伤口的风险增加 感染尿道炎最严重的并发症(包括, 很少,死于脓毒症)通常发生在剖腹产后。 绒毛膜炎和腹膜炎的经济成本(统称 称为围产期感染)是实质性的, 保守估计,在美国, 只有剖腹产感染患有绒毛膜炎的女性的后代 暴露于侵入性诊断测试(例如腰椎穿刺, 脑脊液评估),静脉抗生素治疗,长期 住院,败血症和死亡,幸存者面临的风险增加, 脑瘫此外,照顾婴儿的费用, 患有绒毛膜炎的母亲可能很容易超过 围产期感染因为绒毛膜羊膜炎的病因和 子宫内膜炎是内源性宫颈-阴道上行性感染 阴道和子宫颈的分娩期冲洗, 细菌作为预防围产期感染的合理方法。到 为了在临床上有用,这样的药剂需要具有广泛的 抗微生物活性,并且对母亲无毒和无刺激性, 胎儿理想情况下,该试剂将是市售的且便宜的。 广泛使用的医用消毒剂氯己定满足了这些要求 要求.我们的目标是:1)进行安慰剂对照,双- 盲法随机临床试验,以确定是否在分娩时阴道 用稀释的洗必泰溶液冲洗可以防止或减轻 试验以确定是否在分娩时用稀释的 洗必泰溶液将预防或减轻产妇的严重程度 围产期感染-绒毛膜炎和尿道炎; 2)确定 是否在分娩时用稀释的氯己定进行阴道冲洗 溶液将降低绒毛膜羊膜的微生物侵入率; 3)为了确定是否在分娩时用稀释的 洗必泰溶液将降低急性组织学 绒毛膜炎; 4)确定是否存在细菌性 阴道病与洗必泰的不同作用有关 阴道冲洗对产妇围产期感染率的影响; 5) 确定是否在分娩时用稀释的 洗必泰溶液可降低新生儿败血症的发生率。
英文摘要
Clinically overt infection of the placenta, fetal membranes, or uterus during labor (chorioamnionitis) complicates from 1% to 11% of pregnancies. The incidence of uterine infection after delivery (endometritis) varies from 1%-3% after vaginal delivery to 15-20% after cesarean delivery. Chorioamnionitis is a recognized risk factor for bacteremia and septic shock and is associated with a several-fold increase in the risk for cesarean delivery. Women who undergo cesarean delivery in the setting of chorioamnionitis are at increased risk of serious pelvic and wound infection. The most severe complications of endometritis (including, rarely, death from whelming sepsis) usually occur after cesarean delivery. The economic costs of chorioamnionitis and endometritis (collectively referred to as peripartal infection) are substantial and can be conservatively estimated at $120,000,000 a year in the U.S. for post- cesarean infections alone. The offspring of women with chorioamnionitis are exposed to invasive diagnostic testing (e.g. lumbar puncture for cerebrospinal fluid assessment), intravenous antibiotic therapy, prolonged hospitalization, sepsis, and death, Survivors face an increased risk of cerebral palsy. Furthermore, the costs of caring for infants born to mothers with chorioamnionitis may easily exceed the maternal costs of peripartal infection. Because the etiology of chorioaminonitis and endometritis is ascending infection of endogenous cervico-vaginal bacteria, intrapartum irrigation of the vagina and cervix with an anti- bacterial as a logical approach to prevention of peripartal infection. To be clinically useful, such an agent would need to possess broad antimicrobial activity, and be non-toxic and non-irritating for mother and fetus. Ideally the agent would be commercially available and inexpensive. The widely used medical disinfectant chlorhexidine satisfies these requirements. There we aim: 1) To conduct a placebo-controlled, double- masked, randomized clinical trial to determine whether intrapartum vaginal irrigation with a dilute chlorhexidine solution will prevent or lessen the trial to determine whether intrapartum vaginal irrigation with a dilute chlorhexidine solution will prevent or lessen the severity of the maternal peripartal infections--chorioamnionitis and endometritis; 2) To determine whether intrapartum vaginal irrigation with a dilute chlorhexidine solution will reduce the rate of microbial invasion of the chorioamnion; 3) To determine whether intrapartum vaginal irrigation with a dilute chlorhexidine solution will reduce the rate of acute histologic chorioamnionitis; 4) To determine whether the presence of bacterial vaginosis is associated with a differential effect of chlorhexidine vaginal irrigation on the maternal peripartal infection rate; and 5) To determine whether intrapartum vaginal irrigation with a dilute chlorhexidine solution reduces the rates of neonatal sepsis.
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Brown/WIH Eunice Kennedy Shriver NICHD MFM Units Network Site
Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) Network
Brown/WIH Eunice Kennedy Shriver NICHD MFM Units Network Site
NICHD Maternal Fetal Medicine Units Network
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