Comparison of Carbetocin versus Oxytocin for Prevention of Primary Postpartum Haemorrhage in Women Undergoing Caesarean Section at a Tertiary Care Hospital in West Bengal: A Randomised Recipient Blinded Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Volume of blood loss
研究概览
简要总结
Postpartum haemorrhage (PPH) continues to be the leading cause of maternal mortality in middle and low-income countries including India. Much advancement has been made in the field of treatment of PPH, but not much progress has been made in the field of prevention, where one of its main component is administration of uterotonic, preferably oxytocin, immediately after birth of the baby. In many low- and middle income countries, the efficacy of oxytocin cannot be assured since access to sustained cold-chain is unavailable. Regarding other uterotonics: Ergometrine degrades when exposed to heat or light and Misoprostol degrades rapidly when exposed to moisture. Innovation in the manufacture of carbetocin has met the stability requirements in hot and humid climates. Both Carbetocin and Oxytocin are approved drugs for active managemrent of third stage of labour (AMTSL) and prevention of PPH. This study has been undertaken to evaluate the uterotonic effect of carbetocin compared to oxytocin for the prevention of primary PPH in emergency or elective Caesarean delivery. The purpose of this study is to determine if carbetocin is superior to oxytocin in terms of reduction in the need of additional uterotonic agents and the occurrence of PPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Age 21 to 45 years 2.Emergency or elective Caesarean section 3.Singleton pregnancy.
排除标准
- •1.Contraindication for carbetocin and oxytocin known allergy or hypersensitivity to carbetocin or oxytocin 2.Cases of coagulopathy 3.Multifoetal gestation 4.Medical diseases as cardiac, hypertension, liver, renal or endocrine diseases 5.Uterine fibroids 6.Suspected placental pathology (placenta accreta, praevia or abruption) 7.General anaesthesia 8.Classical uterine incision 9.Those who did not give consent.
结局指标
主要结局
Volume of blood loss
时间窗: First 24 hours post-operative
Use of additional uterotonics
时间窗: First 24 hours post-operative
次要结局
- change in blood pressure(after one hour of drug administration)
- change in pulse rate(after one hour of drug administration)
- change in haemoglobin(24 hours after lscs)
- need of blood transfusion(during first 24 hours post operative)