INJECTION TRANEXAMIC ACID FOR PREVENTING POSTPARTUM HEMORRHAGE AFTER VAGINAL DELIVERY: ONE YEAR HOSPITAL BASED RANDOMIZED,PLACEBO-CONTROLLED TRIAL.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Amount of blood loss at the end of 30 minutes and at the end of 2 hours .
研究概览
简要总结
This is an interventional , randomized, placebo controlled trial to asses the effect of injection tranexamic acid in preventing postpartum hemorrhage after a vaginal delivery, conducted at a tertiary care centre. This study will enroll term pregnant women who are planned for vaginal delivery .Women who have even one of the exclusion criteria will not be enrolled into this study..Randomization will be done by computer based randomisation. Soon after the delivery of the baby, injection tranexamic acid or placebo which is normal saline will be given by intravenous route. The primary outcome will be assessed by the amount of blood loss in the calibrated collector bag which will be placed under the waist of the woman soon after delivery of baby. The secondary outcome will be assessed by the mean change in hemoglobin and packed cell volume.Adverse effects of the drug which include immediate and long term adverse effects will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Term pregnancy 2)Planned vaginal delivery 3)Singleton pregnancy.
排除标准
- •History of thrombosis venous-deep vein thrombosis and/or pulmonary embolism arterial -angina pectoris, myocardial infarction, stroke 2)History of epilepsy or seizure 3)Any known cardiovascular, renal, or liver disorders 4)Autoimmune disease 5)Sickle cell disease 6)Severe hemorrhagic disease 7)Placental Abnormalilty- 8)Placenta previa 9)Invasive placenta (placenta accreta/ increta/ percreta) 10)Abruptio placentae 11)Eclampsia, and HELLP syndrome 12)Intra utero fetal death 13)Administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery 14)Caeserean sections.
结局指标
主要结局
Amount of blood loss at the end of 30 minutes and at the end of 2 hours .
时间窗: Blood loss- End of 30 minutes | End of 2 hours | Time of removal of bag
Mean total blood loss is total blood in the calibrated collector bag at the time of bag removal.
时间窗: Blood loss- End of 30 minutes | End of 2 hours | Time of removal of bag
次要结局
- Laboratory parameters(Hemoglobin)
- Adverse effects of the drug will be noted by monitoring hemodynamic parameters and by follow up visits upto 3 months in the post natal period.(Hemodynamic parameters)
- Patients will be followed up until the day of discharge to know incidence of(Postpartum blood transfusion)