Comparison of effect of phenylephrine and norepinephrine on coagulation during caesarean section in parturients at high risk of postpartum haemorrhage : a randomised, double blind study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Blood loss with prophylactic infusion of phenylephrine and norepinephrine in patients undergoing caesarean section under spinal anaesthesia
研究概览
简要总结
This randomized, double-blind study aims to compare the effect of phenylephrine and norepinephrine infusions on coagulation during caesarean section in parturients at high risk of postpartum haemorrhage. Eighty consenting mothers undergoing caesarean section under spinal anaesthesia with risk factors such as advanced maternal age, abnormal placenta, multiple pregnancy, prior uterine surgery, previous history of PPH or uterine anomalies will be studied. Preoperative haemoglobin and coagulation parameters will be recorded. After administration of spinal anaesthesia, phenylephrine or norepinephrine infusion will be titrated to maintain blood pressure. Post-delivery, oxytocin will be administered, and total blood loss recorded. Haemoglobin and coagulation parameters will be reassessed in the postoperative period. The primary outcome will be total blood loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Consenting mothers scheduled to undergo caesarean section under spinal anaesthesia with at least one of the following conditions: Maternal age more than 35 years Fetal malpresentation Abnormal placenta Previous uterine surgery Uterine distension Previous history of PPH Multiple pregnancy Uterine anomaly (Fibroid).
排除标准
- •History suggestive of bleeding or coagulation disorders Use of anticoagulants or antiplatelet agents within 7 days of surgery History suggestive of Infection, fever, or chorioamnionitis at time of delivery Intrauterine death Patients on monoamine oxidase inhibitors or tricyclic antidepressants History suggestive of Presence of mesenteric or peripheral vascular thrombosis Patients with absolute or relative contraindications for spinal anaesthesia Previous history suggestive of thromboembolism and deep venous thrombosis Hypertensive disorders of pregnancy Known case of Antiphospholipid antibody syndrome, Systemic lupus erythematosus, autoimmune disorders Assisted reproductive technology pregnancy.
结局指标
主要结局
Blood loss with prophylactic infusion of phenylephrine and norepinephrine in patients undergoing caesarean section under spinal anaesthesia
时间窗: Intraoperative and 24 hours postoperative
次要结局
- 1) Changes in haemoglobin levels(2) Coagulation parameters)
研究者
Dr Medha Mohta
University College of Medical Sciences and Guru Teg Bahadur Hospital