Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole
研究概览
简要总结
The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are:
- To examine the side effects and patient acceptability of oral versus intravaginal metronidazole.
- To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV
- To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.
详细描述
This is a randomized, placebo-controlled intervention trial. Women diagnosed as BV+ by Gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (250 mg TID x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel BID x 5 days) with oral placebo. African American, Hispanic, Asian/Pacific Islander, Native American, and white women are eligible. Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.
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, Investigator, Outcomes Assessor)
盲法说明
The Investigational Drug Service at the University of Washington performed the randomization and provided the treatment assignments in opaque, sealed envelopes. Neither the subjects nor the study personnel assessing treatment effect were aware of which active agent had been assigned.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Tested positive for bacerial vaginosis (Nugent score >7)
- •African American, Hispanic, Asian/Pacific Islander, Native American, and white women
排除标准
- •>20 weeks gestaion
- •history of preterm delivery
- •had a multiple gestation pregnancy
- •had major medical complications (e.g., chronic hypertension or pre-existing diabetes)
- •antibiotic use within 7 days of screening visit for enrollment in the study,
- •allergy to metronidazole
- •history of alcohol dependency in past year women under age 16
研究组 & 干预措施
Oral Treatment
oral (250mg three times daily for 7 days) metronidazole
干预措施: oral versus vaginal metronidazole (Drug)
Vaginal Treatment
intravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole
干预措施: oral versus vaginal metronidazole (Drug)
结局指标
主要结局
Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole
时间窗: 4 weeks after treatment
Cure rates were assessed by Gram Stain Score (0-3, 4-6, 7-10); Abnormal clincial signs (0, 1-2, 3-4); Therapeutic cure (Gram Stain 0-3 and no symptoms) treatment
次要结局
- low birth weight(at delivery)
- preterm delivery(at delivery)
研究者
Cynthia Ferre
Lead Health Scientist
Centers for Disease Control and Prevention