The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,226
- 试验地点
- 2
- 主要终点
- Number of Participants With Postpartum Hemorrhage (PPH)
研究概览
简要总结
This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.
详细描述
This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .
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
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing elective or emergency caesarean section with:
- •Estimated gestational age of 37 weeks or more
- •Live intrauterine foetus
- •Elective or emergency caesarean delivery
- •Signed informed consent
排除标准
- •History of coagulopathies or conditions predisposing them to thromboembolic phenomena,
- •seizure history,
- •autoimmune disease,
- •placental abruption,
- •placenta praevia,
- •abnormally adherent placentae if identified on prenatal ultrasound,
- •eclampsia or HELLP syndrome,
- •known hypersensitivity to TXA,
- •planned general anaesthesia,
- •caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin,
- •poor understanding of English/Shona languages,
- •those who have received anticoagulants in the week before delivery
- •persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women
研究组 & 干预措施
Study group/Group A
The study group will receive TXA 1g intravenously at the onset of skin incision.
干预措施: Tranexamic acid injection (Drug)
Control group/Group B
There is an equivalent volume of normal saline for the control group.
干预措施: Normal saline placebo (Other)
结局指标
主要结局
Number of Participants With Postpartum Hemorrhage (PPH)
时间窗: Up to day 2 postpartum
Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.
次要结局
- Mean Blood Loss as Estimated by Obstetrician(2 hours)
- Occurrence of Postpartum Shock(Up to day 2 postpartum)
- Use of Supplementary Uterotonic(s)(Up to day 2 postpartum)
- Number of Severe Adverse Events(Up to day 3 postpartum)
- Number of Participants With a Decrease in Peripartum Hemoglobin(Up to day 2 postpartum)
- Blood Pressure Measurements(Up to 2 hours after the caesarean section)
- Blood Loss Using Hemoglobin Values(Up to day 2 postpartum)
- Postpartum Transfusion(Up to day 2 postpartum)
- Emergency Surgery for PPH(Up to day 2 postpartum)
- Change in Peripartum Haematocrit(Up to day 2 postpartum)
- Change in Peripartum Haemoglobin(Up to day 2 postpartum)
- Admission Into Intensive Care Unit(Up to day 2 postpartum)
- Death From Any Cause(Up to date of death or day 4 from admission)
- Number of Mild Adverse Events(Up to 24 hours after administration)
- Any Other Unexpected Adverse Event(Up to day 3 postpartum)
- Length of Hospital Stay(Up to day 3 postpartum)
研究者
Chipo Gwanzura, MD
Senior Registrar
University of Zimbabwe