Prophylactic Oral Tranexamic acid to reduce blood loss during vaginal delivery in high risk women
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 1.To study the efficacy of prophylactic oral Tranexamic acid as an adjunct to AMTSL in reducingblood loss at the time of placental separation and immediate post partum period upto 2 hours in high risk vaginal deliveries.
研究概览
简要总结
WHO trial has shown that IV tranexamic acid is effective in management of PPF but at lower level health facilities or home deliveries, parenteral administration is not practicable. In such situation, oral tranexamic acid if found to be effective in reducing blood loss after delivery, can be used by the concerned health care providers/ low resources set up areas. As high risk parturients for obstetrical haemorrhage may be the one that would benefit the most from prophylactic tranexamic acid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •MODERATE AND SEVERE ANAEMIA GRAND MULTIPARA PROLONGED LABOR MULTIPLE PREGNANCY MACROSOMIA POLYHYDRAMNIOS PIH APH ABRUPTION UTERINE PATHOLOGY LIKE FIBROID THROMBOCYTOPENIA PPROM CHORIOAMNIONITIS Patient for TOLAC.
排除标准
- •Known allergy to Tranexamic acid Patient on LMWH or antiplatelet agent Medical past history of thromboembolism, autoimmune disease,sickle cell anaemia,bleeding disorders, renal disease,liver disease, known cardiovascular disease.
结局指标
主要结局
1.To study the efficacy of prophylactic oral Tranexamic acid as an adjunct to AMTSL in reducingblood loss at the time of placental separation and immediate post partum period upto 2 hours in high risk vaginal deliveries.
时间窗: 2 hours post delivery
2. To determine the incidence of PPH in 2 groups (with and without oral Tranexamic acid).
时间窗: 2 hours post delivery
次要结局
- 1. To study side effects of oral Tranexamic acid in the medication group.(2 hours post delivery)
研究者
Dr Soraanganbee Okram
Dr. Baba Saheb Ambedkar Hospital, Rohini, Delhi