Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Estimated blood loss
研究概览
简要总结
In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process further by inhibiting the fibrinolytic system.
TXA is an antifibrinolytic that has been studied in many different patient population for its use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and recent evidence have found promising results in its use for prophylaxis of PPH.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All English speaking patients
- •Above 21 year old
- •Undergoing elective caesarean section.
排除标准
- •Known/suspected placenta accreta antenatally
- •Contraindications to syntocinon and tranexamic acid such as hypersensitivity to these medications
- •Known thrombophilia or coagulopathy
- •History of thromboembolic events
- •Severe cardiac/renal/liver disease
- •Poorly controlled hypertension /severe preeclampsia (BP > 160/100)/eclampsia
研究组 & 干预措施
Intervention group
Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision, and Intravenous oxytocin 5 units post delivery of the baby.
干预措施: Tranexamic acid (Drug)
Control group
Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby
干预措施: Normal saline (Drug)
结局指标
主要结局
Estimated blood loss
时间窗: Intraoperative
This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85.
次要结局
- Change in hemoglobin and hematocrit level(Preoperative to 48 hours postoperative)
- Need for additional medical intervention including blood transfusion, additional uterotonics(During surgery and up to 3 days after surgery)
- Diagnosis of thromboembolic events in the neonate(Up to 4 weeks post delivery)
- Provider estimated blood loss(Intraoperative)
- Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery(During surgery and up to 24 hours from surgery)
- Neonatal admission to special care nursery or intensive care unit(At delivery)
- Neonatal APGAR score(At delivery)
- Neonatal birth weight(At delivery)
- Gravimetric estimation of blood loss during the surgery(Intraoperative)
- Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism(Intraoperative to 4 weeks post surgery)