Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During Elective Cesarean Delivery in Patients With Placenta Previa
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- Amount of blood loss
研究概览
简要总结
Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa.
Patients will be randomly assigned into two groups:
Group (A) - Study group (n=28): The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.
Group (B) - Control group (n=28): The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 20-40 years old.
- •BMI less than 30 kg/m
- •Pregnancy of singleton living fetus.
- •Placenta previa by ultrasound assessment
- •Gestational age > 36 weeks.
排除标准
- •Women with a history of any medical disorder with pregnancy, e.g., Gestational diabetes and hypertension.
- •Women with systemic diseases, e.g., diabetes mellites, systemic immune disorders such as systemic lupus erythematosus
- •Women with bleeding tendency or coagulopathy.
- •Women on anticoagulants or hemodynamically unstable women.
- •Women with uterine abnormalities, such as fibroids or polyps.
- •Emergency termination of pregnancy.
- •Intrauterine fetal death.
- •Pregnancy with obstetric hemorrhage, e.g., antepartum hemorrhage
- •Cases of placenta accrete spectrum disorder or placental abruption
- •Women with known allergies to Tranexamic acid
研究组 & 干预措施
Study group (n=28)
The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.
干预措施: Topical tranexamic acid (Drug)
Study group (n=28)
The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.
干预措施: Intravenous tranexamic acid (Drug)
Control group (n=28)
The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.
干预措施: Intravenous tranexamic acid (Drug)
结局指标
主要结局
Amount of blood loss
时间窗: during operation
amount of intraoperative blood loss during CS in patients with placenta previa
次要结局
- operative time(during operation)
研究者
Abdalla Mousa
Lecturer of obgyn Cairo university
Cairo University