The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for Reducing Blood Loss During Hemorrhagic Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- number of patients need of additional pharmacological uterotonic
研究概览
简要总结
Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section
详细描述
Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with 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
- None
盲法说明
open label Randomized Clinical Tria
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
- •patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml
排除标准
- •placenta praevia and placental abruption
- •Women with a medical disorder,
- •placenta accrete,
- •allergy to TA, and
- •intraoperative bleeding thanks to causes aside from uterine atony
- •Patients over 40 or who have
- •pre-existing coagulation disorders,
- •with a severe medical disorder
- •allergy to tranexamic acid
- •refuse to consent
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
干预措施: Topical tranexamic acid (Drug)
normal saline
temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
干预措施: normal saline (Drug)
结局指标
主要结局
number of patients need of additional pharmacological uterotonic
时间窗: 24 hours post operative
calculation number of patients need of additional pharmacological uterotonic
次要结局
- amount of postoperative blood loss(4 hours postoperative)
- estimation of intraoperative blood loss (ml)(during the operation)
- number of patient with postpartum hemorrhage(24 hours post operative)
研究者
hany farouk
Principal Investigator
Aswan University Hospital