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临床试验/NCT00545181
NCT00545181已完成不适用

Recurrent Bacterial Vaginosis (RBV): Efficiency of Metronidazole in Comparison to Metronidazole and Intravaginal Acidifying Gel: A Randomized Investigator-blinded Controlled Trial

Indiana University School of Medicine1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2007年9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
55
试验地点
1
主要终点
Recurrent Bacterial Vaginosis

研究概览

简要总结

Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.

详细描述

Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All women of between 18-50 years of age.
  • Confirmed current diagnosis of BV using Amsel's criteria.
  • Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months

排除标准

  • Patient who received antibiotic therapy within the past two weeks.
  • Patients who had co-existing gonorrhea or Chlamydia infection
  • Any contraindications or sensitivity to taking the vaginal gel.
  • Allergy to metronidazole
  • Alcoholics or those unable to abstain from alcohol consumption.

研究组 & 干预措施

Metronidazole plus gel

Experimental

Receive metronidazole plus vaginal gel

干预措施: Vaginal acidifying gel (RepHresh) (Drug)

Control- metronidazole alone

Active Comparator

Oral Metronidazole antibiotic therapy alone

干预措施: Metronidazole control (Drug)

结局指标

主要结局

Recurrent Bacterial Vaginosis

时间窗: 3 months

Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH \>4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.

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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