NCT02279186Unknown4 期
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial .
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Amount of blood loss during cesarean section after placental delivery till end of the operation.
研究概览
简要总结
In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.
详细描述
To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment 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
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- Women undergoing caesarean delivery for various elective indications.
- •Full term primiparas / multiparas.
- •Singleton pregnancy being delivered by LSCS.
排除标准
- •- Medical problems involving the heart, liver, kidney and brain .
- •Blood disorders.
- •Allergy to tranexamic acid.
- •History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
- •Multiple pregnancy, macrosomia.
- •Polyhydromnios .
- •Patients requiring blood transfusion due to anemia
研究组 & 干预措施
group A
Active Comparator
receiving tranexamic acid
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Amount of blood loss during cesarean section after placental delivery till end of the operation.
时间窗: during and 2hours post cesarean section
次要结局
- 1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .(up to 24hours postoperative)
- Adverse affect of tranexamic acid on mother and neonate .(first 24 hours)
- 24 hours post operative haemoglobin and haematocrit .(after 24 hours.)
研究者
Mahmoud Mostafa Abdellah Mostafa
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial.
Ain Shams Maternity Hospital
研究点 (1)
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