NCT00186082已完成不适用
A Randomized Controlled Trial of the Effect of Prophylactic Antibiotics on the Infection Rate in Postpartum Third and Fourth Degree Perineal Tear Repairs
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- No perineal breakdown or infection
研究概览
简要总结
This study is undertaken to find out whether prophylactic antibiotics can decrease the infection rate in third and fourth degree perineal tear repairs done in the immediate postpartum period.
详细描述
After obtaining consent patients who sustained third or fourth degree perineal laceration after vaginal delivery were randomly assigned to a single dose of antibiotic (cefotetan or cefoxitin, 1 g intravenously or clindamycin, 900 mg intravenously, if allergic to penicillin), or placebo (100ml normal saline) intravenously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •third and fourth degree perineal laceration
排除标准
- •chorioamnionitis, HIV positive, inflammatory bowel disease
研究组 & 干预措施
Cefotetan, Cefoxitin or Clindamycin
Active Comparator
干预措施: Cefotetan or Cefoxitin vs placebo (Drug)
Normal Saline
Placebo Comparator
干预措施: Cefotetan or Cefoxitin vs placebo (Drug)
结局指标
主要结局
No perineal breakdown or infection
时间窗: Six weeks post partum
次要结局
未报告次要终点
研究者
研究点 (2)
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