Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Vaginal lactobacillus recolonization
研究概览
简要总结
Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton pregnancy
- •gestational age 12-32 weeks
- •diagnosis of bacterial vaginosis
- •treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days
排除标准
- •multiple pregnancy
- •allergy to clindamycin
研究组 & 干预措施
Vaginal lactobacilli
干预措施: Lactobacillus acidophilus (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Vaginal lactobacillus recolonization
时间窗: 3-5 weeks
Recurrence rate of bacterial vaginosis
时间窗: 3-5 weeks
次要结局
- Preterm delivery <37 weeks(within 43 weeks of gestation)
研究者
Federico Prefumo
Consultant in Obstetrics and Gynaecology
Università degli Studi di Brescia