To Evaluate the Role of Prophylactic Use of Tranexamic Acid in Reducing Blood Loss during Caesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Total blood loss (in mL) measured intraoperatively and up to 2 hours postoperatively
研究概览
简要总结
Caesarean section routinely entails greater blood loss than vaginal delivery, placing women at risk of
perioperative anaemia, transfusion and its complications. Standard uterotonic protocols (oxytocin ±
additional agents) do not fully prevent bleeding in all cases. Tranexamic acid (TXA) is a cost-effective
antifibrinolytic that stabilises clot formation.
This double-blind, randomised, placebo-controlled trial will evaluate whether a single 1 g IV dose given
pre-operatively reduces intraoperative and early postpartum blood loss in women undergoing elective
or emergency caesarean section.
Primary endpoints are measured blood loss (gravimetric + suction canister) and change in haemoglobin
and haematocrit at 24 hours. Secondary endpoints include transfusion requirement, additional
uterotonic use and any TXA-related adverse events.
We hypothesise that TXA will significantly decrease perioperative bleeding and transfusion needs
without increasing complications, supporting its routine prophylactic use in caesarean practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Singleton, term pregnancy Informed consent provided.
排除标准
- •Multiple pregnancy Pre-eclampsia Macrosomia Polyhydramnios Fibroid complicating pregnancy Placental abnormalities (e.g., placenta previa, abruptio placentae, placenta accreta/increta/percreta) History of bleeding disorders Allergy to tranexamic acid Systemic complications involving the heart, liver, or kidneys Prolonged or obstructed labour Parity greater than.
结局指标
主要结局
Total blood loss (in mL) measured intraoperatively and up to 2 hours postoperatively
时间窗: Total blood loss (in mL) measured intraoperatively and up to 2 hours postoperatively
次要结局
- Change in haemoglobin and haematocrit levels(24 hours post surgery)
- Requirement for blood transfusion(24 hours)
- Use of additional uterotonic agents(24 hours)
- Adverse effects related to tranexamic acid(42 days)
- Postoperative complications(42 days)
研究者
Dr Chirag Sharma
Dr Radhakrishnan Government Medical College and Hospital, Hamirpur, H.P