跳至主要内容
临床试验/CTRI/2025/03/082261
CTRI/2025/03/082261Not Applicable2 期

Randomized Control Trial to compare Carbetocin and Oxytocin in the prevention of Postpartum Hemorrhage (PPH) in Elective Caesarean Section

Indian Naval Hospital Ship Asvini1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月24日最近更新:

试验速览

阶段
2 期
状态
Not Applicable
发起方
入组人数
120
试验地点
1
主要终点
Carbetocin is better compared to Oxytocin in prevention of Post partum haemorrhage

研究概览

简要总结

Postpartum hemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide, accounting for around one-fourth of all maternal deaths. Elective Caesarean Section (ECS) is a known risk factor for PPH, with an incidence of PPH ranging from 3.3% to 6.5%. Oxytocin is the current standard of care for the prevention of PPH during ECS, with certain limitations, such as need for refrigeration and short half-life. Carbetocin is a newer uterotonic drug that has shown to be as effective as oxytocin in the prevention of PPH, with the added advantage of longer half-life and no need of refrigeration. However, there is a lack of data on the comparative effectiveness of Carbetocin and Oxytocin in preventing PPH during ECS.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • all willing pts term pregnancies undergoing elective lscs.

排除标准

  • all unwilling pts, emergency LSCS,pts with cardiac disease,renal disease,liver disease, epilepsy.

结局指标

主要结局

Carbetocin is better compared to Oxytocin in prevention of Post partum haemorrhage

时间窗: till 48 hours post surgery

次要结局

  • Carbetocin is similar to Oxytocin in prevention of post partum haemorrhage(till 48 hours post surgery)

研究者

发起方
Indian Naval Hospital Ship Asvini
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sandyarani Dodamani

INHS Asvini

研究点 (1)

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