CTRI/2012/05/002622尚未招募3 期
Tranexamic acid for the treatment of post-partum haemorrhage: An International randomized, double blind placebo controlled trial.
Indian Council of Medical Research ICMR20 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2012年5月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15,000
- 试验地点
- 20
- 主要终点
- The primary outcome is the proportion of women who die or undergo hysterectomy. the primary cause of death will be described.
研究概览
简要总结
The women Trail aims to determine the effect of the early adminstration of Tranexamic acid on mortality, hysterectomy and other morbidities (surgical interventions, blood tranfusion, risk of nonfatal vascular events) in woman with clinically diagonsed postpartum haemorrhage. the use of health services and safety, espically thromoboembolic effect, on brestfeed babies will also be assessed.
研究设计
- 研究类型
- Interventional
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •All legally adult women with clinically diagnosed postpartum haemorrhage following vaginal delivery of a baby or caesarean section; women may have delivered their babies at a participating hospital of outside a participating hospital, with hospital admission following delivery: Where the responsible clinician is substantially uncertain as to whether or not to use TXA When consent has been given according to approved procedures.
- •The clinical diagnosis of PPH may be based on any of the following: Estimated blood loss after vaginal delivery of a baby >500 mL OR >1000 mL from caesarean section OR Estimated blood loss enough to compromise the haemodynamic status of the woman.
排除标准
- •Women for whom the responsible clinician considers there is a clear indication for TXA should not be randomized.
- •Women for whom the responsible clinician considers there is a clear contraindication for TXA should not be randomized (e.g. a known thrombembolic even during pregnancy).
结局指标
主要结局
The primary outcome is the proportion of women who die or undergo hysterectomy. the primary cause of death will be described.
时间窗: 6 weeks
次要结局
- a) Death(b) surgical interventions: including hysterectomy, brace suture (b-lynch/cho), selective arterial)
研究者
研究点 (20)
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