RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 809
- 试验地点
- 16
- 主要终点
- Safety: device-related Adverse Events
研究概览
简要总结
The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.
详细描述
The purpose of this registry is to collect observational data on patients treated with the Jada System in the post-market setting. Data collection will include observations of effectiveness and safety of the device. Additional outcome data related to resource utilization will also be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Use of the Jada System (inserted into the patient and connected to vacuum).
- •NOTE: There is no Exclusion Criteria in this protocol.
排除标准
- 未提供
结局指标
主要结局
Safety: device-related Adverse Events
时间窗: 24 hours through time of discharge.
Rates of procedure- and device-related adverse events.
Efficacy: Cessation of PPH
时间窗: 24 hours
Proportion of patients with atony-related abnormal postpartum uterine bleeding or PPH successfully treated with the Jada System. Treatment success is defined as the avoidance of escalated non-surgical or surgical intervention to control abnormal postpartum uterine bleeding or PPH after the Jada System was used. Note: Concomitant treatment with uterotonics or uterine compression sutures does not constitute escalation (i.e., failure). However, if the Jada treatment was aborted to instead administer treatment with compression sutures for ongoing bleeding, then the event does meet the escalation (i.e., failure) definition.
次要结局
- Transfusion rates(24 hours through time of discharge.)
- Length of stay(24 hours through time of discharge.)
- Time spent in care settings(24 hours through time of discharge.)
- Rate of non-surgical or surgical procedures other than Jada(24 hours)
- In-dwelling time of Jada during treatment(24 hours)