Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 608
- 试验地点
- 2
- 主要终点
- Composite Postoperative Infectious Morbidity
研究概览
简要总结
The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
详细描述
Cesarean delivery is the most common surgical procedure performed on women in the US; nearly 1.3 million are performed each year. Postoperative infectious morbidity is the most common complication of cesarean delivery. Post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. Thus, reducing vaginal microbial load may reduce post-cesarean infection. However, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed.
The investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.
排除标准
- •Inability to obtain consent
- •known or suspected allergy to iodine or shellfish
- •women with active herpes simplex virus infection
结局指标
主要结局
Composite Postoperative Infectious Morbidity
时间窗: 30 days postoperatively
Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection.
次要结局
- Adverse Reaction to Vaginal Cleansing(30 days postoperatively)
- Number of readmissions to hospital for infectious morbidity.(30 days postoperatively)
- Number of outpatient visits for infectious morbidiy.(30 days postoperatively.)
- Treatment for neonatal Sepsis(30 days postoperatively)
- Length of Hospital Stay(30 days postoperatively)