Prophylactic Use of Topical Tranexamic Acid to Aid Surgical Haemostasis During Caesarean Sections in Parturients With Moderate to High Risk of Bleeding
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Total intra-operative blood loss in the Tranexamic Acid (TXA) group compared to the Control group
研究概览
简要总结
The objective of this study is to investigate whether topical application of tranexamic acid into the uterine cavity and the surgical site intra-operatively can reduce blood loss and provide better surgical haemostasis in parturients with moderate to high risk for bleeding undergoing caesarean deliveries.
详细描述
1.1 BACKGROUND
Maternal haemorrhage is a significant cause of maternal mortality and morbidity worldwide. The incidence of postpartum haemorrhage (PPH) with blood loss in excess of 1000ml is estimated to affect 10.5% of live births globally. This translate to a staggering number of 14 million women in the reproductive age group who suffers from complications of severe blood loss during childbirth every year. While the case fatality rate is low at around 1%, non-fatal health outcomes as a result of PPH remains unknown and this is further compounded by considerable variability in patients tolerance towards blood loss.
Certainly, not all parturients experience similar risks for bleeding during their pregnancy. However, it is important to consider that even small amounts of blood loss may have a detrimental effect on maternal health especially in parturients with preexisting medical conditions like anaemia or cardiac disease. Measures aimed at addressing this global problem need to be given top priority in line with the United Nations Fifth Millennium Developmental Goal to improve maternal health and to reduce maternal mortality ratio by 75% by the year 2015.
Parturients undergoing caesarean section experience more blood loss compared to their counterparts who deliver vaginally. Recent studies reported average blood loss of 254ml to 304ml for vaginal deliveries and 500ml to 592ml for caesarean deliveries. Identifying the risks and causes of PPH and recognising that PPH is a significant contributor to maternal mortality and morbidity is important to encourage efforts for early identification of parturients at risk of bleeding. However, despite the advances in modern obstetrics, PPH remains a significant problem not only in the developing world but also in countries with high resources and better medical facilities and presumably where more efficient protocols for management of PPH are in existence.Obviously, this indicate the need to explore newer methods for more effective prevention and treatment of PPH in the quest to improve maternal health.
1.2 INVESTIGATIONAL AGENT AND MECHANISM OF ACTION
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturients aged more than 18 years old
- •American Society of Anesthesiologists (ASA) physical status class 1 to 3
- •Parturients planned for caesarean sections (both emergency and elective) under regional anaesthesia
- •Parturients who have increased risks of bleeding during caesarean deliveries as follows:
- •Moderate Risk for Bleeding
- •Induction of labour
- •Prolonged labour >12 hours
- •Large baby > 4kg
- •Pyrexia in labour
- •Age > 40 years (not multiparous)
- •Obesity (BMI >35)
- •Anaemia (Hb < 9g/dl)
- •Multigravida
- •Previous history of PPH
- •Previous scars
- •High Risk for Bleeding
- •Known bleeding disorders (congenital or acquired)
- •Multiple pregnancies
- •Preeclampsia and pregnancy induced hypertension
- •Placenta praevia
- •Placenta accreta/increta/percreta
- •Placenta abruption
排除标准
- •Parturients who have an urgent/emergency indication for caesarean sections where timing of the operation may be critical in determining the maternal and/or foetal outcomes
- •Patients who are planned for caesarean sections under general anaesthesia
- •Patients who are already clinically bleeding prior to surgery
- •Parturients who received blood transfusion within 48 hours prior to the caesarean section
- •Patients with known allergy to tranexamic acid
- •Patients with clear contraindications for tranexamic acid (e.g. thromboembolic event, history of convulsions)
- •Patients with severe renal failure with creatinine clearance <10
研究组 & 干预措施
Tranexamic acid (TXA) Group
Subjects in the TXA group will receive the topical tranexamic acid solution which will be administered intra-operatively, during the caesarean section on the surgical wound and into the intrauterine cavity after the delivery of the baby and the placenta. 60mls of the solution will be applied topically to the placental bed as identified by the surgeon carrying out the surgery by spraying the study solution using a syringe into the uterine cavity. Another 30mls of the solution will be applied to the open incision wound. The surgeon will then proceed to close the first layer of the uterus in the usual manner. The remaining 30mls of the study drug solution is then applied topically on the closed incision wound
干预措施: Topical tranexamic acid (Drug)
Control Group
Subjects in the Control group will receive topical normal saline solution which will be administered intra-operatively in the same manner as described for the TXA group.
干预措施: Normal saline 0.9% (Drug)
结局指标
主要结局
Total intra-operative blood loss in the Tranexamic Acid (TXA) group compared to the Control group
时间窗: From the start of the surgery (first surgical incision) up to the end of the surgery (at wound closure)
Total intra-operative blood loss will be measured at the end of the surgery (at wound closure). The following formula will be used: Total intra-operative blood loss (ml) = A + B - C where A = Blood volume in suction bottle (ml) B = Wet weight of all gauzes and drapes soaked with blood (g) C = Dry weight of all gauzes and drapes soaked with blood (g) (assumption of 1 gram of blood is equivalent to 1ml of blood) The blood loss quantified will be documented in subjects case report form
次要结局
- Haematocrit trends at baseline (Pre-operative) and at 6 hours post surgery in the TXA group and the Control group(Pre-operatively within 24 hours prior to start of surgery (before surgical incision) up to 6 hours from the end of surgery (wound closure))
- Transfusion requirements in terms of number of red blood cell packets transfused up to 24 hours post surgery(From start of surgery (first surgical incision) up to 24 hours post surgery (wound closure))
研究者
Dr Meng-Li Lee
Specialist Anaesthetist
Ministry of Health, Malaysia