Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 2
- 主要终点
- Number of Participants With Postpartum Haemorrhage (PPH)
研究概览
简要总结
Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.
The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.
Methods and Design The investigators intend to perform an open label randomized control study of 1,162 women who are undergoing elective caesarean section. The participants will be randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision or not to receive the intervention. Prophylactic oxytocin will be administered to all the women.
The primary outcome will be incidence of PPH defined by blood loss equal to or more than 1,000ml calculated by determining the difference in haematocrit values taken prior to and 48 hours after caesarean section.
Discussion In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.
This large adequately powered randomized study seeks to determine the efficacy of TXA to validate its routine use at caesarean section to prevent PPH.
详细描述
RESEARCH QUESTION Does intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5 International Units (IU) result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section.
RATIONALE FOR THE RESEARCH Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe, PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.
In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.
The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.
RESEARCH OBJECTIVES
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
盲法说明
Trial is an open label randomized control trial
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman with signed informed consent***
- •Understand English and/or Shona
- •Estimated gestational age of 38 weeks or older
- •Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour
- •Live intrauterine fetus
- •The study will enrol participants who are Pregnant and who have a signed informed Consent form. Some of the pregnant women may be minors as they are occasionally included in patients planned for elective caesarean section for varying indications. Their inclusion also will make the results of the trial generalizable to elective caesarean section patients attended to at the two study hospitals. Consent will be sought from a legally authorized representative such as the parent or guardian.
排除标准
- •Placental Abruption
- •Emergency caesarean section
- •Current or previous history of significant disease including heart disease, liver, renal disorders
- •Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke)
- •History of epilepsy or seizures
- •Autoimmune disease
- •Sickle cell disease
- •Severe haemorrhagic disease
- •Intrauterine fetal demise
- •Eclampsia/HELLP syndrome
- •Administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery
研究组 & 干预措施
Group A
Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.
干预措施: Tranexamic Acid (Drug)
Group A
Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.
干预措施: Oxytocin (Drug)
Group B
Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby
干预措施: Oxytocin (Drug)
结局指标
主要结局
Number of Participants With Postpartum Haemorrhage (PPH)
时间窗: Up to 48 hours post-caesarean section
PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation
次要结局
- Amount of Blood Transfused(At caesarean section up to 48 hours post-caesarean section)
- Number of Participants With Tranexamic Acid Side Effects(From intravenous infusion of the drug up to 48 hours post-caesarean section)
- Estimated Blood Loss(At caesarean section)
- Number of Participants With Use of Additional Uterotonics(At caesarean section up to 48 hours post-caesarean section)
- Number of Days of Participants' Hospital Stay(From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier)
- Neonatal Outcome - Weight(From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier)
- Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery(Scores at 1 minute from time of delivery and at 5 minutes after delivery)
- Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit(From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier)
- Neonatal Outcome - Thromboembolic Event(From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier)
- Neonatal Outcome - Death(From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier)
- Number of Participants Requiring Emergency Surgery for PPH(At caesarean section up to 48 hours post-caesarean section)
- Neonatal Outcome - Number of Neonates Diagnosed With Jaundice(From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier)
研究者
Chipo Gwanzura, MD
Junior Registrar
University of Zimbabwe