A randomized controlled, open labelled clinical trial comparing the efficacy of carbetocin versus oxytocin in prevention of post partum hemorrhage.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Primary outcome is to compare the efficacy of carbetocin and oxytocin in preventing intraoperative blood loss
研究概览
简要总结
To summarise this study, postpartum haemorrhage is a major concern nowadays in high-risk patients for PPH undergoing cesarean section. although oxytocin is a gold standard drug in preventing PPH and carbetocin a novel drug came to the market with flying colours is used to prevent PPH, comparing these two drugs by administering to high risk PPH patients who are all undergoing c section.
in this study we can measure the hemodynamic variability in both intra operative as well post operative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women aged 18 yrs to 50 years.
- •2.Multiple pregnancy.
- •3.Scheduled for Elective cesarean section under spinal anaesthesia.
- •4.Prolonged third stage labour.
- •5.Fetal macrosomia.
- •6.History of post partum hemorrhage.
- •7.Grand multiparity.
- •8.Placenta previa.
- •9.Placental abruption.
- •10.Pregnancy induced hypertension.
- •11.ASA I and II.
排除标准
- •1.Patient refusal.
- •2.History of thromboembolic disorder.
- •3.Patients suffering from other chronic illness like COPD or any active LRTI.
- •4.Preexisting neuropathy.
- •5.Eclampsia and HELLP syndrome.
- •6.Contraindication to Spinal anesthesia.
- •7.Any known allergy to local anaesthetia or general anaesthesia.
结局指标
主要结局
Primary outcome is to compare the efficacy of carbetocin and oxytocin in preventing intraoperative blood loss
时间窗: 1.(T0) at carbetocin /oxytocin injection. | 2.(T1) end of operation procedure. | 3. (T3) 2 hr post operative period. | 4. (T4) 12 hr post operative period.
次要结局
- haemodynamic variable(after administering two drugs take taken in T1 min)
研究者
DR V Bhuvaneshwaran
Department of anaesthesiology