Effects of Tranexamic Acid on Post Partum Hemorrhage by Uterine Atony After Cesarean Section Delivery: a Randomized, Placebo Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- volume blood loss
研究概览
简要总结
The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.
This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA1 parturients
- •aged from 20 to 40
- •correct preoperative haemostatic status (prothrombine ratio > 60 % and platelet rate > 100 000),
- •cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone
排除标准
- •abnormal placentation
- •severe pre-eclampsia
- •coagulopathy and uterine rupture
- •the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.
研究组 & 干预措施
tranexamic acid, post partum hemorrhage
干预措施: Tranexamic Acid (Drug)
placebo
干预措施: saline serum (Drug)
结局指标
主要结局
volume blood loss
时间窗: within 5 days after delivery
次要结局
- transfusion rates.(within 5 days after delivery)
研究者
mohamed ayedi
Principal Investigator
Hédi Chaker Hospital