Post-marketing Safety and Efficacy Surveillance of Motherwort Injection : a Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 主要终点
- The type and incidence of adverse events.
研究概览
简要总结
This study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the clinical indications for the use of motherwort injection
- •Voluntarily participate in this study
- •Fulfill ethical requirements.
排除标准
- 未提供
研究组 & 干预措施
Patients indicated for Motherwort injection
During the registration and enrollment period of the study, all patients who meet the clinical indications for the use of motherwort injection, as determined by the physician, and voluntarily agree to participate while fulfilling ethical requirements, will be recruited from designated medical institutions and departments. The observation period for each observer was established based on the clinical application of motherwort injection.
干预措施: Motherwort injection (Drug)
结局指标
主要结局
The type and incidence of adverse events.
时间窗: From the initiation of medication to 7 days after cessation.
Bleeding control.
时间窗: From the commencement of the surgery to the end of bleeding event, assessed up to 1 year.
Including:1. Hysteroscopic surgery: the intraoperative blood loss, the postoperative blood loss, the cumulative bleeding time. 2.Uterine fibroid resection: the intraoperative blood loss, the postoperative blood loss, the cumulative bleeding time.
The incidence of postpartum hemorrhage.
时间窗: From the completion of the surgery to 24 hours following the delivery of the fetus.
Postpartum hemorrhage is defined as a blood loss of ≥500 ml following vaginal delivery or ≥1000 ml following cesarean delivery, or the presence of symptoms or signs of hypovolemia associated with blood loss within 24 hours .
The post-abortion recovery.
时间窗: From the completion of the abortion to the subsequent onset of menstruation, assessed up to 1 year.
The interval time to the resumption of menstruation post-surgery.
The incidence of post-abortion bleeding.
时间窗: From the completion of the abortion to the end of bleeding event.
The cumulative days of postoperative bleeding.
次要结局
- The types and incidence of adverse reactions.(From the initiation of medication to 7 days after cessation.)
- Analysis of factors associated with adverse reactions.(From the initiation of medication to 7 days after cessation.)
- The menstrual adjustment.(From the initiation of medication to menstruation returns to normal or the treatment is completed, whichever came first, assessed up to 1 year.)
- The uterine retraction status.(From the the postpartum to the end of bleeding event, assessed up to 1 year.)
研究者
Zhong Wang
Sponsor
China Academy of Chinese Medical Sciences