Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Number of participants with a fever after delivery
研究概览
简要总结
Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.
详细描述
The PATPET trial is a randomized, controlled trial done at tertiary hospital obstetric units in Israel. Women who had first and second-degree tear (or after episiotomy) after delivery at 37 weeks or greater gestation, with no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic Cefamezin (cefazolin), were randomly assigned (1:1) to receive a single intravenous dose of prophylactic antibiotic or not.
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
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18-45
- •perineal tear 2nd and 1st degree( episiotomy)
排除标准
- •3rd and 4 th degree perineal tear
- •antibiotic indication during delivery
- •cesarian section delivery
研究组 & 干预措施
Prophylactic antibiotic treatment
Will be given Cefamezin antibiotic within 6 hours of delivery
干预措施: Cefazolin (Cefamezin) (Drug)
结局指标
主要结局
Number of participants with a fever after delivery
时间窗: 6 weeks of delivery
Maternal fever above 38 C (Celsius)
次要结局
- Way of delivery(6 weeks of delivery)
研究者
Yair Daykan
Principal Investigator
Meir Medical Center