Effectiveness of Carbetocin versus Oxytocin in prevention of postpartum hemorrhage during Caesarean section in singleton pregnancy; Randomised clinical trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- BLOOD LOSS
研究概览
简要总结
Postpartum hemorrhage remains the leading cause of maternal mortality in developing countries and a significant proportion of these cases are attributable to uterine atony. In contrast to the advances made in the treatment of postpartum hemorrhage, there has been few novel prophylactic agents. This study will be undertaken to analyze the Effectiveness of carbetocin compared to oxytocin for the prevention of postpartum hemorrhage in caesarean section in singleton pregnancy.
With this background, we will be conducting a study to compare the Effectiveness of Carbetocin Versus Oxytocin in Prevention of Postpartum Hemorrhage During Caesarean Section in Singleton Pregnancy : Randomised Clinical Trial
This study will be a randomized single blinded, comparative study, to be carried out in 120 participants, undergoing Caesarean section under spinal/general anesthesia/ CESA . The patients will be randomly divided into 2 groups of 60 each. Group A (n=60 ) will receive 100 mcg of Inj. Carbetocin . Group B (n=60 ) will receive 10 IU Inj. Oxytocin.
The blood pressure , amount of hemoglobin , need of additional uterotonics , uterine tone , uterine position, urine output, occurrence of adverse effects will be assessed and recorded. All the findings and observations made during the entire study will be tabulated, graphically depicted wherever possible, statistically analysed and inference will be drawn to evaluate and compare the Effectiveness of Carbetocin Versus Oxytocin in Prevention of Postpartum Hemorrhage During Caesarean Section in Singleton Pregnancy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Age: 18 to 45 years.
- •2.Period of gestation ≥ 28weeks.
- •3.Willing to participate in study.
排除标准
- •âž¢ History of epilepsy and coagulation disorders ➢ Eclampsia, HELLP syndrome in present pregnancy ➢ History of classical uterine incision ➢ Patients with Cardiovascular, Renal, Hepatic disorders in present and past pregnancies ➢ Placenta previa ➢ Abruptio placentae ➢ Past h/o PPH.
结局指标
主要结局
BLOOD LOSS
时间窗: Intra operatively and at 24 hours from OT
次要结局
- 1.BLOOD PRESSURE(2.UTERINE TONE)
研究者
Dr Aishwarya H K
RIMS.