Use of Tranexamic Acid for the Prevention of Postpartum Haemorrhage After Cesarean Section in High-risk Patients ( a Randomized Control Trial ).
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Volume of blood loss
研究概览
简要总结
Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).
详细描述
Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).
The second dose of TXA 1 g Intravenous can be given if:
- Bleeding continues after 30 minutes
- Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess efficacy of TXA in prevention of PPH and reduction of intra and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Scheduled or unscheduled cesarean delivery. Singleton or twin gestation.
- •Women at high risk for PPH after cesarean section:
- •Placenta previa, accreta, increta or percreta. haematocrit (HCT) < 30%. Bleeding at admission. History of Postpartum haemorrhage. Abnormal vital signs (hypotension or tachycardia). Previous Cesarean or uterine surgery. More than four previous deliveries. Multiple Gestation. Large Uterine fibroids. Chorioamnionitis. Magnesium sulphate use. Prolonged use of oxytocin.
排除标准
- •Age less than 18 years.
- •Women who are not at high risk for PPH.
- •Women attending for normal vaginal delivery.
- •Pre-existing maternal hemorrhagic conditions such as Factor 8 deficiency - haemophilia A carrier, Factor 9 deficiency - haemophilia B carrier or Von Willebrand's disease.
- •Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated.
- •Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis.
- •Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism
- •Need for a therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA.
- •Hypersensitivity to TXA or any of its ingredients.
- •Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative haemorrhage
- •Seizure disorder (including eclampsia), and its use has been associated with postoperative seizures..
- •Active cancer, because of the risk of thromboembolism.
- •Congestive heart failure requiring treatment, because of the risk of thrombosis.
- •If there is no haemoglobin and hematocrit result available from the last 4 weeks since it is necessary to measure the postoperative change in haemoglobin and hematocrit.
研究组 & 干预措施
study group will be given tranexamic acid
Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).
The second dose of TXA 1 g Intravenous can be given if:
- Bleeding continues after 30 minutes
- Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
干预措施: Tranexamic Acid 100 milligram/Milliliter (Drug)
study group will be given tranexamic acid
Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).
The second dose of TXA 1 g Intravenous can be given if:
- Bleeding continues after 30 minutes
- Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
干预措施: Oxytocin (Drug)
Control group
The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )
干预措施: Oxytocin (Drug)
结局指标
主要结局
Volume of blood loss
时间窗: 30 minutes after baby delivery
150 ml/pack
次要结局
- Tranexamic acid side effects(24 hours postpartum)
- Maternal death(7 days postpartum)
- additional medical intervention(48 hours postpartum)
- transfusion requirements(7 days postpartum)
- additional surgical or radiological interventions to control bleeding(7 days postpartum)
- Change in maternal hematocrit concentration(48 hours postpartum)
- thromboembolic events(7 days postpartum)
研究者
Dr. Abou Bakr Mohamed El Nashaar
Professor
Benha University