The Effect of Using Tranexamic Acid Soaked Absorbable Gelatin Sponge in Reducing Rectus Sheath Hematoma Formation After Cesarean Section in Patients Using Warfarin Compounds
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Excessive bleeding from subrectus space
研究概览
简要总结
The aim of this randomized controlled study is to demonstrate the effect of Local application of TXA impregnated in a gelatin sponge in reducing Rectus sheath hematoma formation in patients treated with warfarin following cesarean section.
详细描述
The study will include (63) pregnant women attending for cesarean delivery who will receive anticoagulation (warfarin) postnatally.
Patients included in this study will be subjected to:
- Informed consent: patients representing the study population will be counselled about the intervention and informed written consent will be taken.
Consenting patients will be subjected to the following:
- Detailed personal, obstetric and medical and surgical history. 2- Examination: General Examination.
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
- Double (Participant, Investigator)
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
- •o Pregnant women attending for elective CS.
- •Women on antenatal anticoagulation ( LMWH , UFH , Fondaparinux ) for conditions such as : Prosthetic Valve , DVT , Pulmonary embolism , Dural sinus thrombosis , AF.
- •Pregnant Women with indication for postnatal warfarin anticoagulation( Prosthetic Valve , DVT , Dural Sinus Thrombosis , AF , Pulmonary embolism )
- •Age between 20-40 years.
- •Pregnancies between 37 and 39 weeks
- •BMI between (18.5 - 30.0)
排除标准
- •o Pregnancy with risk of obstetric hemorrhage such as abnormally invasive placenta, placenta previa, placental abruption.
- •Women with Renal and Hepatic failure
- •Women with bleeding diathesis for reasons other than warfarin anticoagulation therapy
- •Women with known allergy to Tranexamic acid
- •Anemia Hb below 8g/dl
研究组 & 干预措施
Gelatin Sponges soaked with TXA
21 patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior rectus sheath and the rectus abdominis muscle, one sponge on each muscle.
干预措施: Tranexamic acid (Drug)
Gelatin Sponges
2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2)
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Excessive bleeding from subrectus space
时间窗: 1 week
amount of blood coming out of the drains
Rectus sheath hematoma formation
时间窗: 1 weeks
Rectus sheath hematoma formation detected by Ultrasound
次要结局
- Blood transfusion(1 week)
- Thromboembolic manifestations(1 weeks)
- The need for surgical evacuation of rectus sheath hematoma(1 week)
研究者
Ayman Hany, MD
Associate Professor
Cairo University