Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- neonatal infection rate
研究概览
简要总结
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to 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
- 否
入选标准
- •term (≥ 37+0 weeks) singleton pregnancy
- •a vertex presentation
- •ruptured membranes for less than 12 hours
- •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 (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
- •contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery
研究组 & 干预措施
Antibiotic group
women submitted to antibiotic prophylaxis
干预措施: Ampicillin + gentamicin (Drug)
结局指标
主要结局
neonatal infection rate
时间窗: participants will be followed for the duration of hospital stay, an expected average of 3 days
neonatal infection rate includes early onset sepsis, meningitis and pneumonia
maternal infection rate
时间窗: participants will be followed for the duration of hospital stay, an expected average of 3 days
maternal infection rate includes chorioamnionitis or puerperal endometritis
次要结局
- comparison of the infection rates between prompt and delayed induction(participants will be followed for the duration of hospital stay, an expected average of 3 days)
研究者
Filipa Faria Vaz Passos
Principal investigator
Hospital de Santa Maria, Portugal