The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 568
- 试验地点
- 2
- 主要终点
- Maternal and neonatal infection rate
研究概览
简要总结
The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.
详细描述
In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).
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
- •term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks.
排除标准
- •active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, contraindication to expectant management or to vaginal delivery
研究组 & 干预措施
Immediate induction with antibiotic prophylaxis
Immediate induction with antibiotic prophylaxis
干预措施: Cefoxitin (Drug)
Immediate induction with antibiotic prophylaxis
Immediate induction with antibiotic prophylaxis
干预措施: oxytocin/misoprostol (Drug)
Immediate induction without antibiotic prophylaxis
Immediate induction without antibiotic prophylaxis
干预措施: oxytocin/misoprostol (Drug)
Delayed induction with antibiotic prophylaxis
Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis
干预措施: Cefoxitin (Drug)
Delayed induction with antibiotic prophylaxis
Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis
干预措施: oxytocin/misoprostol (Drug)
结局指标
主要结局
Maternal and neonatal infection rate
时间窗: intrapartum and immediate postpartum
次要结局
未报告次要终点
研究者
Filipa Faria Vaz Passos
Principal Investigator
Hospital de Santa Maria, Portugal