Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora
研究概览
简要总结
Abnormal vaginal flora is a risk factor for preterm labor. Therefore, in high risk pregnancies for preterm labor the diagnosis and treatment of abnormal flora is indicated. Clindamycin and metronidazole given orally are both acceptable treatments in these cases. The purpose of this study is to compare the effectiveness of Clindamycin Vs metronidazole for the treatment of abnormal vaginal flora in high risk pregnancies. For this purpose, pregnant women who are considered high risk for preterm labor and were diagnosed with abnormal vaginal flora will be randomly treated either with clindamycin or metronidazole. Eradication of the abnormal flora and adverse effects will be monitored and compared
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
- 是
入选标准
- •Pregnant women at increased risk for preterm labor (preterm cervical effacement, preterm uterine contractions, twins pregnancy, vaginal bleeding, past preterm delivery)
- •Age above 18 years
排除标准
- •Known allergy to the tested antibiotics
- •Antibacterial treatment in the week before the vaginal culture was taken
- •preterm premature rupture of membranes
研究组 & 干预措施
clindamycin
干预措施: Clindamycin (Drug)
metronidazole
干预措施: Metronidazole (Drug)
结局指标
主要结局
To compare the efficacy between oral Clindamycin Vs Metronidazole in the eradication of abnormal vaginal flora
时间窗: Primary outcome will be assessed by taking a vaginal culture sample a week after one-week antibacterial treatment
次要结局
- The prevalence of late abortions and preterm deliveries(From date of randomization until the date of delivery or abortion, assessed up to 28 weeks)
- Assessing the correlation between Nugent score , physical examination and Ph indicators(The outcome is assessed after the diagnosis of abnormal vaginal flora is made at 14-26 weeks of gestation)
- The prevalence of adverse effects(During the antibacterial treatment which is 1 week of therapy)