Comparison of the Effect of Tranexamic Acid Versus Misoprostol on Blood Loss During and After Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Reduction in Hemoglobin
研究概览
简要总结
Brief Summary
The goal of this clinical trial is to compare two medicines, intravenous tranexamic acid and rectal misoprostol, for reducing blood loss in women undergoing cesarean section. The study will also compare how much hemoglobin (a measure of blood loss) decreases after surgery with each treatment.
The main questions the study aims to answer are:
- Does intravenous tranexamic acid reduce the drop in hemoglobin more than rectal misoprostol after cesarean section?
- Does intravenous tranexamic acid reduce blood loss during and within 2 hours after cesarean section more than rectal misoprostol?
Researchers will randomly assign 214 women scheduled for cesarean section to receive either intravenous tranexamic acid or rectal misoprostol before surgery. All cesarean sections will be performed according to the hospital's standard procedures by experienced obstetricians.
Participants will:
i. Be randomly assigned to receive either intravenous tranexamic acid or rectal misoprostol before surgery.
ii. Have their hemoglobin level measured before the cesarean section and again 2 hours after surgery.
iii. Have blood loss measured during the operation and for 2 hours after surgery.
iv. Have the duration of the operation recorded as part of the study.
The results will help determine which treatment is more effective in reducing blood loss and preserving hemoglobin levels during and after cesarean section.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •37 to 42 weeks of gestation
- •Planned cesarean section
排除标准
- •Women with pre-eclampsia
- •Chronic hypertension
- •Multiple pregnancies
- •Preterm or postdate pregnancy
- •Previous cesarean section
- •Gestational diabetes
- •Fetal macrosomia
- •History of bleeding / clotting disorder
- •On anti-coagulation heparin / warfarin therapy
- •Non-reassuring cardiotocograph or poor progress of labor
结局指标
主要结局
Reduction in Hemoglobin
时间窗: Baseline at enrollment and postoperative within 2 hours
Reduction in hemoglobin will be calculated as the difference between preoperative and 2-hour postoperative hemoglobin concentrations (g/dL).
次要结局
未报告次要终点
研究者
Urooj Mumtaz
Principal Investigator
Medicare Hospital (Pvt) Limited