Longitudinal Clinical, Controlled, Randomized, Open-label, Phase III Study to Assess the Equivalence of Tranexamic Acid (TXA) vs Oxytocin (OXY) in Reducing Post Partum Haemorrhage (PPH) in Patients at the End of Pregnancy (37-42 w), at Low Risk of PPH
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- assessment of total blood loss expressed in mL
研究概览
简要总结
The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery (the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when blood loss arose within 24 hours after birth.
详细描述
This trial includes three arms of treatment :
- arm A (IMP1Test): TXA 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5 minutes from the delivery(third stage af labor)
- arm B (IMP2Control): OXY 5 IU/ml/ 2 vials (10 International Unit) intramuscularly within 5 minutes from the delivery (third stage af labor) The clamping of the umbilical cord will be executed immediately after birth.
The randomization 1:1 (block design), generated by the computer.
Primary outcomes: assessment of total blood loss expressed in mL:
- immediately after delivery
- two hours after delivery
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects at the end of pregnancy ( 37-42 w ) at low risk of PPH Mean by low-risk of PPH subjects without any of the following risk factors : hypertension/preeclampsia, placental abruption during pregnancy , placenta previa , tocolysis two hours before delivery, multiple pregnancy , previous PPH, obesity ( BMI > 35 ), anemia (Hb < 7 g/dL), elective caesarean section , induction of labor, retention of placental material , polyhydramnios , fever during labor, use of high doses of heparin low molecular weight.
- •Subjects full capacity and the willingness to give written informed consent .
排除标准
- •Subjects with preterm pregnancy (<37 weeks ) or with prolonged pregnancy ( > 42 weeks )
- •Subjects at the end of pregnancy ( 37 weeks - 42 weeks ) with the following risk factors for PPH (Tab1.Protocol Study, vers.2.0 of 07/05/2016)
- •multiple pregnancy
- •History of thromboembolic disease or high incidence of thromboembolic events in family history ( patients at high risk of thrombophilia )
- •Patients with Long - QT syndrome or who are taking drugs that cause QT prolongation
- •Intrauterine fetal Death
- •Autoimmune disease Tab1 medical history :
- •Placental abruption during pregnancy
- •Placenta previa
- •Hypertension / preeclampsia
- •Previous PPH
- •Polyhydramnios
- •Obesity ( BMI > 35 )
- •Anemia ( < 7 g / dL )
研究组 & 干预措施
arm A (TXA)
2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery(third stage after labor)
干预措施: Tranexamic Acid (Drug)
arm B (OXY)
2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
干预措施: Oxytocin (Drug)
结局指标
主要结局
assessment of total blood loss expressed in mL
时间窗: two hours after delivery
global blood loss \> 500 mL
次要结局
- assessment of the need of using additional uterotonic(two hours after delivery)
- assessment of the number of hemodynamic changes(immediately after delivery)
- assessment the need for surgical manoeuvres for the bleeding control(two hours after)
- assessment the need for the blood transfusions(two days after delivery)
- evaluation of the number of cases in which the following was seen verified:(two days after delivery)