PROPHYLACTIC TRANEXAMIC ACID IN REDUCING POSTPARTUM HEMORRHAGE IN CESAREAN SECTIONS
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Measured blood loss from skin incision to 24 hours postpartum using calibrated drapes (intra-op)
研究概览
简要总结
Investigating the efficacy of tranexamic acid (TXA) as a prophylactic agent in reducing postpartum haemorrhage (PPH) among patients undergoing cesarean section (CS) in SQUH: a prospective randomized controlled trial.
详细描述
To evaluate the efficacy of tranexamic acid (TXA) in reducing blood loss during elective and emergency caesarean sections in comparison to placebo. Research methodology, A Prospective, double blinded, randomized - control trial.
Tranexamic acid has been found to be an effective drug and is recommended in the management of post partum haemorrhage. However there are limited studies in its use as a prophylactic agent in the prevention of post partum haemorrhage.
Introduction
Postpartum haemorrhage (PPH) remains a leading cause of maternal morbidity and mortality worldwide, accounting for nearly one-quarter of all maternal deaths. Caesarean section (CS), while a life-saving procedure, is associated with an increased risk of PPH compared to vaginal delivery. Haemorrhage following CS is most commonly due to uterine atony, where ineffective uterine contraction after delivery leads to excessive bleeding.
Additional contributors include surgical trauma, retained placental tissue, and coagulation disorders.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman with risk factors for postpartum haemorrhage undergoing elective and emergency caesarean section in SQUH. Risk factors for postpartum haemorrhage include previous CS, multiple pregnancy, polyhydramnios, foetal macrosomia (BW >4kg), anemia, booking BMI>30, previous history of PPH, fibroids, adenomyosis, placenta previa (non- accreta), chorioamnionitis.
排除标准
- •Woman with condition like Placenta accreta spectrum, contraindications to tranexamic acid (e.g., hypersensitivity to tranexamic acid), history of seizure disorders, kidney disease, thromboembolic disease, or medical conditions or treatments associated with a high risk of thrombosis will be excluded from the study
研究组 & 干预措施
Experimental arm
Women who receive intravenous, Tranexamic acid for prophylaxis of postpartum hemorrhage
干预措施: tranexamic acid (1 g diluted in 100 mL of 0.9% saline (Drug)
Placebo comparator
Women who will receive 0.9% saline, intravenous, volume matched
干预措施: Normal (0.9%) saline (Drug)
结局指标
主要结局
Measured blood loss from skin incision to 24 hours postpartum using calibrated drapes (intra-op)
时间窗: 18 months
Measured blood loss from skin incision to 24 hours postpartum using calibrated drapes (intra-op) + gravimetric method (pads/linens) and suction canister accounting for irrigation, and Incidence of PPH ≥1000 mL within 24 hours after CS.
次要结局
未报告次要终点