Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis.
Metronidazole to prevent preterm delivery in pregnant women with asymptomatic bacterial vaginosis.
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DOI：
10.1056/nejm200002243420802
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发表时间：
2000-02-24
影响因子：
158.5
通讯作者：
Varner, M
中科院分区：
文献类型：
--
作者：
Carey, JC;Klebanoff, MA;Varner, M
背景：细菌性阴道病与早产有关。在临床试验中，对曾经早产过的孕妇进行细菌性阴道病的治疗可以降低复发的风险。方法：为了确定对一般产科人群中无症状细菌性阴道病（根据阴道革兰氏染色和pH值诊断）的妇女进行治疗是否能预防早产，我们随机分配了1953名怀孕16至不到24周的妇女，分别给予2 g剂量的甲硝唑或安慰剂。诊断研究重复进行，并对所有怀孕24至不到30周的妇女进行第二次治疗。主要指标为妊娠37周前的分娩率。结果：845名接受甲硝唑革兰氏染色随访的女性中，657人（77.8%）的细菌性阴道病痊愈，859名安慰剂组中321人（37.4%）的阴道病痊愈。甲硝唑组953名妇女和安慰剂组966名妇女的分娩时间和特征数据可获得。甲硝唑组116名妇女早产（12.2%），安慰剂组121名妇女早产（12.5%）（相对危险度1.0；95%可信区间0.8 - 1.2）。治疗并不能预防自然分娩引起的早产（甲硝唑组5.1%对安慰剂组5.7%）或自发胎膜破裂（4.2%对3.7%），也不能预防32周前分娩（2.3%对2.7%）。甲硝唑治疗并没有减少早产、羊膜内或产后感染、新生儿败血症或新生儿重症监护病房的发生率。结论：对孕妇无症状细菌性阴道病的治疗并不能减少早产或其他不良围产期结局的发生。[J] .中华医学杂志2000；32(3):534- 534。(C)2000年，马萨诸塞州医学协会。
Background: Bacterial vaginosis has been associated with preterm birth. In clinical trials, the treatment of bacterial vaginosis in pregnant women who previously had a preterm delivery reduced the risk of recurrence.Methods: To determine whether treating women in a general obstetrical population who have asymptomatic bacterial vaginosis (as diagnosed on the basis of vaginal Gram's staining and pH) prevents preterm delivery, we randomly assigned 1953 women who were 16 to less than 24 weeks pregnant to receive two 2-g doses of metronidazole or placebo. The diagnostic studies were repeated and a second treatment was administered to all the women at 24 to less than 30 weeks' gestation. The primary outcome was the rate of delivery before 37 weeks' gestation.Results: Bacterial vaginosis resolved in 657 of 845 women who had follow-up Gram's staining in the metronidazole group (77.8 percent) and 321 of 859 women in the placebo group (37.4 percent). Data on the time and characteristics of delivery were available for 953 women in the metronidazole group and 966 in the placebo group. Preterm delivery occurred in 116 women in the metronidazole group (12.2 percent) and 121 women in the placebo group (12.5 percent) (relative risk, 1.0; 95 percent confidence interval, 0.8 to 1.2). Treatment did not prevent preterm deliveries that resulted from spontaneous labor (5.1 percent in the metronidazole group vs. 5.7 percent in the placebo group) or spontaneous rupture of the membranes (4.2 percent vs. 3.7 percent), nor did it prevent delivery before 32 weeks (2.3 percent vs. 2.7 percent). Treatment with metronidazole did not reduce the occurrence of preterm labor, intraamniotic or postpartum infections, neonatal sepsis, or admission of the infant to the neonatal intensive care unit.Conclusions: The treatment of asymptomatic bacterial vaginosis in pregnant women does not reduce the occurrence of preterm delivery or other adverse perinatal outcomes. (N Engl J Med 2000;342:534-40.) (C)2000, Massachusetts Medical Society.