A comparative study of hemodynamic effects of Oxytocin and Carbetocin in women undergoing lower segment cesarean section under spinal anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Compare the differences in haemodynamic responses using Mean Arterial Pressure (MAP) among both the groups before and after administration of uterotonics after delivery of baby.
研究概览
简要总结
A total of 174 pregnant women undergoing elective LSCS under sub arachnoid block will be enrolled and randomly allocated into two groups of 87 each by computer generated randomized table. Study drugs will be administered after the delivery of baby and clamping of cord. Effect of the drugs will be noted on MAP, SBP, DBP, HR and oxygen saturation as baseline and then followed by 30 sec, 1 min, 5 min, 10 min, 15 min and 30 min after administration of drugs. Other parameters like level of uterine contraction achieved, additional dose of uterotonics if required, dose of vasopressors used, amount of blood loss during operation, requirement of transfusion if any and any other adverse effect will also be assessed. Thus, hemodynamic effects of uterotonics oxytocin and carbetocin will be compared.
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 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Term gestation between 37 weeks to 42 weeks undergoing elective LSCS.
排除标准
- •1- Conditions of fetal distress 2- Patients with systemic diseases 3- Hydramnios (oligo or poly hydramnios) 4- Placenta previa 5- Ecclampsia, pre ecclampsia 6- Gestational diabetes mellitus 7- Prematurity 8- Borderline cephalo pelvic disproportion 9- Previous classical CS or any other major surgery on uterus 10- Patients undergoing LSCS under GA.
结局指标
主要结局
Compare the differences in haemodynamic responses using Mean Arterial Pressure (MAP) among both the groups before and after administration of uterotonics after delivery of baby.
时间窗: Baseline, 30 sec after, 1 min, 5 min, 10 min, 15 min and 30 min after administration of uterotonic after delivery of baby.
次要结局
- 1- Compare other haemodynamic parameters like Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Heart rate (HR), Oxygen saturation (SpO2) and compare need for vasopressor support after administration of uterotonic after delivery of baby,(2- Compare level of uterine contraction achieved and if any additional dose of uterotonics is required,)
研究者
Dr Mridula Pandey
Institute of Medical Sciences, BHU