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临床试验/NCT00720291
NCT00720291已完成不适用

Inflammation and Treatment of Bacterial Vaginosis Near Term

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha

研究概览

简要总结

Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm birth. Despite this, there is no evidence that screening and treatment of asymptomatic bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent rate of preterm birth. However, treatment of symptomatic bacterial vaginosis has been associated with a modest reduction in subsequent preterm birth. Potential mechanisms for this reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1 inflammatory cascade with treatment, however this direct pathway has not been elucidated. The approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg BID for 7 days. A more complete understanding of the effect of Metronidazole on maternal inflammation would be useful in designing strategies to reduce the rates of preterm birth.

This study proposes to determine the effect of standard treatment of BV carriage on maternal serum markers of inflammation. This will be accomplished by giving patients with asymptomatic BV either the standard treatment of metronidazole or a placebo for 7 days. Blood will be drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 32 weeks gestation or greater
  • Multiparity
  • No history of preterm birth
  • English speaking
  • Ability to provide informed consent
  • Bacterial vaginosis by gram stain

排除标准

  • Acute infections at any site
  • Active autoimmune disease
  • Current anti-inflammatory use
  • Symptomatic bacterial vaginosis
  • Previous adverse reaction to metronidazole
  • Reports ongoing ethanol consumption

研究组 & 干预措施

Metronidazole

Active Comparator

Subjects who are randomly assigned to receive metronidazole 500 mg po for a period of 7 days following diagnosis of asymptomatic BV.

干预措施: Metronidazole (Drug)

Placebo

Placebo Comparator

Subjects who are randomly assigned to receive a placebo for a period of 7 days following the diagnosis of asymptomatic BV.

干预措施: Placebo (Drug)

结局指标

主要结局

Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha

时间窗: 3-5 days after start of treatment

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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