Carbetocin and oxytocin in elective cesarean delivery in patients with high risk of postpartum hemorrhage under spinal anesthesia a comparative double blind randomized control study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Oxytocin and carbetocin in terms of adequate uterine contractility and prevention of intraoperative blood loss
研究概览
简要总结
Postpartum Haemorrhage is the most common cause of maternal mortality worldwide and accounts for nearly one-quarter of all maternal pregnancy related deaths. Currently, WHO recommends active management of third stage of labor for prevention of postpartum Haemorrhage which includes administration of uterotonics after delivery of anterior shoulder,i.e, Inj.Oxytocin 20 IU . Carbetocin has been recommended by WHO as an effective uterotonic in its 2018 guidelines for prevention of PPH.100 micrograms (mcg) of Carbetocin, injected as a slow Iv bolus over 1 minute, should be used instead of continuous oxytocin infusion in elective cesarean section to prevent PPH.
This study intend to evaluate the efficacy and safety of carbetocin compared to oxytocin in prevention of postpartum haemorrhage in high risk patients of post partum haemorrhage posted for cesarean delivery in Tezpur medical college and Hospital.
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 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients of the ASA grade 1 and 2 with gestation of 37 weeks or more, who had an elective cesarean delivery under spinal anesthesia with risk factors of postpartum haemorrhage such as multiple pregnancy,two or more previous cesarean section,presence of uterine fibroids,previous myomectomy,past history of postpartum haemprrhage,prolonged labor,fetal macrosomia,BMI 35 and more and fetal malformations with polyhydramnios.
排除标准
- •ASA garde 2, allergy to study drugs,patients contraindicated for spinal anesthesia,Declined to participate,premature rupture of memebrane,pregnancy induced hypertension,antepartum haemorrhage,patients in active labor,inadequate block after apinal anaesthesia,history of epilepsy,diabetes mellitus,ischemic heart disease,cerebrovascular disease,hepatic and renal disease.
结局指标
主要结局
To assess the efficacy of Oxytocin and carbetocin in terms of adequate uterine contractility and prevention of intraoperative blood loss
时间窗: To assess the efficacy of Oxytocin and carbetocin in terms of adequate uterine contractility and prevention of intraoperative blood loss in first 24 hrs of delivery
次要结局
- compare the heamodynamic effects of carbetocin and oxytocin(HR,MAP,ECG)(to asses the need for additional uterotonics in cesarean section at high risk of PPH)
研究者
Somnath debnath
Tezpur medical college and hospital