The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Hypertensive Women Undergoing Elective Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- intraoperative blood loss
研究概览
简要总结
In hypertensive women having an elective cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.
详细描述
patients were allocated to one of two groups after induction of anesthesia. they received temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo
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)
盲法说明
a double-blinded randomized controlled trial
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •hypertensive women undergoing elective cesarean section
排除标准
- •Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
- •patients with the high possibility of the morbid adherent placenta,
- •known coagulopathy and
- •those presented with severe antepartum hemorrhage
- •refuse to participate
研究组 & 干预措施
Topical tranexamic acid
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo
干预措施: Topical tranexamic acid (Drug)
结局指标
主要结局
intraoperative blood loss
时间窗: 30 minutes
measures the intraoperative blood loss by direct and gravimetric methods
次要结局
- need of uterotonic(24 hours)
- change in hemoglobin(24 hours)
- need of blood transfusion(12 hours)
研究者
hany farouk
A Professor
Aswan University Hospital