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临床试验/CTRI/2024/03/064265
CTRI/2024/03/064265尚未招募2 期

Hemodynamic effects of Carbetocin and Oxytocin given as an intravenous bolus in a women undergoing caesarean delivery: A randomised trail

Bangalore medical college and research institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月26日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Comparison of maternal heart rate

研究概览

简要总结

Postpartum hemorrhage (PPH) is a potentially life threatening complication of both vaginal and caesarean delivery. The prevalence of PPH is approximately 6% of all the deliveries. The most frequent cause of PPH is uterine atony. Surprisingly the incidence has increased in recent years even in some of the developed countries. Therefore active management of third stage of labor rather than expectant management is recommended. Currently intravenous injection of 5U of Oxytocin is recommended as the prophylactic medication of choice to reduce the incidence and severity of PPH. Oxytocin has a short half-life with t 1/2 of 6mins. Hemodynamic effects of an oxytocin bolus consists of systemic vasodilation with hypotension , tachycardia and increase in cardiac output. Carbetocin a synthetic analogue of oxytocin with a longer half-life of approximately 40mis, exerts it’s effects via the same molecular mechanisms as oxytocin, and has been reported to decrease the use of additional oxytocics. Unlike oxytocin, carbetocin is a heat-stable drug and does not require cold chain transport and storage.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.Parturients who are willing to give informed written consent
  • Parturients of all age groups 3.

排除标准

  • 未提供

结局指标

主要结局

Comparison of maternal heart rate

时间窗: To assess after 1,3,5,7,10 minutes after administration of the drugs

次要结局

  • Comparison of other hemodynamic parameters like SBP, DBP and MAP(To assess after 1,3,5,7,10 minutes after administration of the drugs)

研究者

发起方
Bangalore medical college and research institute
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Syeda Kubra

Bangalore medical college and research institute

研究点 (1)

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