NCT01736852已完成不适用
Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients
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
- 129
- 试验地点
- 4
- 主要终点
- Time of Labor
研究概览
简要总结
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •PROM not in labor
排除标准
- •Contraindication to vaginal delivery
- •Contraindication to labor induction
- •Abnormal fetal heart-rate patterns
- •Maternal heart disease
- •Severe maternal hypertension
- •Pelvic structural abnormality
研究组 & 干预措施
CRB plus Pitocin
Experimental
干预措施: CRB (Device)
CRB plus Pitocin
Experimental
干预措施: Pitocin (Drug)
Pitocin
Active Comparator
干预措施: Pitocin (Drug)
结局指标
主要结局
Time of Labor
时间窗: Start of labor induction through delivery, an expected average of 6 hours
Time, in minutes, from the start of labor induction through delivery
Incidence of Infection
时间窗: Through hospital discharge, an expected average of 3 days
number of patients with chorioamnionitis
次要结局
未报告次要终点
研究者
研究点 (4)
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