Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Related Pregnancy Outcomes
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Number of Participants who transformed to negative status of bacterial vaginosis
研究概览
简要总结
The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the patients with durative positive result. It is assumed that the living preparation of lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment can increase the response rate and improve pregnancy outcomes in the durative BV positive patients comparing with one-course one.
详细描述
Research method: This was a single-blind randomized controlled trial.
Diagnostic standard: The study population is the women who have positive outcome of screened test for BV by sialidase method.
Allocation and follow up: Patients who were screened for BV by sialidase method and randomly allocated into control group、one-course group and two-course group. The patients in control group who were BV positive would receive lotion washout and be repeatedly evaluated BV status per two weeks and be followed up to the 4th～7th days of postpartum. The patients in one-course group and in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. The patients in two-course group will receive the second course treatment of Lactobacilli preparation if their BV test result were still positive after one-course treatment, but those in one-course group would NOT receive any treatment even though they would have the durative BV positive result after one-course of Lactobacilli. The patients in the two interventional groups would be repeatedly evaluated BV status at 28th gestational weeks and be followed up to the 4th-7th days of postpartum. All the inspection results of vaginal secretions and pregnancy outcome were recorded.
Outcome measures:
- The prevalence of BV,the response rates of lactobacillus preparation,the recurrence rate.
- The adverse pregnancy outcomes of mother.
- The adverse pregnancy outcomes of perinatal fetus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women at 16-18 gestational weeks with no history of premature labor or premature rupture of fetal membranes.
排除标准
- •who have menstrual disorder or forget the last menstrual period, and have no type-B ultrasonic result, so the gestational week is not clear.
- •Who have monilial vaginitis, trichomonas vaginitis, or sexual transmitted diseases.
- •who have severe medicochirurgic diseases.
- •multiple pregnancy.
- •anomalies of genital tract
- •fetal anomaly
研究组 & 干预措施
lotion
lotion:the patients in control group receive washing medicine and are followed up to the 4rd～7th days of postpartum.
干预措施: Vaginal capsules of lactobacilli (Drug)
lactobacilli capsule
干预措施: Vaginal capsules of lactobacilli (Drug)
lactobacilli capsules
干预措施: Vaginal capsules of lactobacilli (Drug)
结局指标
主要结局
Number of Participants who transformed to negative status of bacterial vaginosis
时间窗: 6 months
The patients who were BV positive would receive treatment and be repeatedly evaluated BV status on the time of post-treatment 1 week, 28th gestational weeks, and before birth, respectively.The number of Participants who transformed to negative status of bacterial vaginosis will be recorded. The rates of bacterial vaginosis transformed to negative status will be calculated.
次要结局
- pregnancy outcome of mother(6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum))
- pregnancy outcome of perinatal fetus(6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum))
- Safety and tolerability(6 months (from 16~18 gestational weeks to the 4th-7th days of postpartum))
研究者
Li Yanfang
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine