A comparison of Oxytocin and Carbetocin for the prevention of postpartum haemorrhage in high risk patients undergoing cesarean delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Oxytocin and Carbetocin in terms of intraoperative blood loss, additional uterotonic needed and adverse effects if any in caesarean delivery with high risk of post-partum haemorrhage. To compare the hemodynamic effects of Oxytocin and Carbetocin (effects on heart rate and blood pressure)
研究概览
简要总结
Post partum hemorrhage(PPH) is still a major cause of maternal morbidity and mortality. PPH is responsible for majority of maternal mortality in India and globally. There have been few studies/literature of effectiveness of carbetocin for the prevention of PPH following cesarean delivery, hence we decided to do a prospective study comparing prophylactic administration of oxytocin and carbetocin and to study its efficacy in prevention of PPH in high-risk females undergoing cesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •High risk pregnant patients posted for elective cesarean delivery under spinal anaesthesia of ASA Grade III and IV with 35-40 weeks of gestation, Multiple pregnancies, Previous cesarean scar, Presence of uterine fibroids, Previous myomectomy, Presence of placenta previa, Past history of PPH.
排除标准
- •Hypertension, Preeclampsia, Cardiac diseases, Renal diseases, Liver diseases, Epilepsy, Neuromuscular diseases, Severe anemia, General Anaesthesia, Women with history of hypersensitivity to carbetocin/oxytocin, Patient refusal.
结局指标
主要结局
To assess the efficacy of Oxytocin and Carbetocin in terms of intraoperative blood loss, additional uterotonic needed and adverse effects if any in caesarean delivery with high risk of post-partum haemorrhage. To compare the hemodynamic effects of Oxytocin and Carbetocin (effects on heart rate and blood pressure)
时间窗: Heart rate and blood pressure noted before skin incision, after 1 minute, 3 minutes, 5 minutes, at the time of skin closure, after 2 hours, after 12 hours. Uterine tone noted at time of delivery and after 3 minutes, 6 minutes, 9 minutes, 12 minutes, 2 hours, 12 hours.
次要结局
- 1)Demographic data(2)Uterine tone)