跳至主要内容
临床试验/CTRI/2022/04/041583
CTRI/2022/04/041583尚未招募不适用

Effectiveness of Carbetocin in Caesarean section for prevention of Post-partum haemorrhage(PPH) in comparison with Oxytocin at a tertiary Institute: A randomised controlled study

RIMS Imphal Golden Jubilee research Initiative1 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2022年5月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
346
试验地点
1
主要终点
To compare the amount of blood loss as well as the uterine tone following carbetocin and oxytocin in caesareansection

研究概览

简要总结

Obstetric haemorrhage, especially postpartum haemorrhage (PPH) is responsible for more than a quarter of all maternal deaths worldwide. In most low-income countries, PPH is the leading cause of maternal deaths. Postpartum haemorrhage occurs in 5-15% of deliveries. The majority of PPH related morbidity and mortality are preventable through effective implementation of  evidenced-based guidelines. Uterine atony is responsible for more than 50% of occurrences of PPH, numerous strategies have been promoted to preserve uterine tone.There are several uterotonic drugs for preventing PPH but it is still debatable which drug is best. Oxytocin (10 IU) is administered for the prevention of PPH in low risk vaginal and caesarean deliveries. Carbetocin is a long-acting synthetic oxytocin analogue, 1-deamino-1- monocarbo-(2-O-Methyltyrosine)-oxytocin, firstly described in 1987. Carbetocin, given as 100 microgram as an IV bolus over 1 minute, instead of continuous infusion of oxytocin with a a similar safety profile and minor antidiuretic effect, in the third stage of labour and in the first 24 hours. Crabetocin is approved by WHO (2018) and included in the WHO (2019) essential medicines drug list. Storage and cold chain maintenance of Oxytocin is difficult unlike heat stable carbetocin in Manipur. Recently it has been approved by drug controller of India for use in prevention of  PPH and is now available in India. In Manipur, carbetocin has not been used and no such study in pregnant women for PPH prevention.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant Blinded

入排标准

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

入选标准

  • Term Pregnant women reporting to the department of Obstetrics & Gynaecology who will be undergoing caesarean section and giving informed consent in the Regional Institute of Medical Sciences, a tertiary care centre of Imphal, Manipur.

排除标准

  • Presence of Hypertension, antepartum haemorrhage, fibroid uterus or history of myomectomy, cardiac, renal or liver diseases, epilepsy, bleeding disorders, general anaesthesia and history of hypersensitivity to any drugs.

结局指标

主要结局

To compare the amount of blood loss as well as the uterine tone following carbetocin and oxytocin in caesareansection

时间窗: Blood loss, Uterine tone and Vitals are monitored immediately, 2 hours and 24 hours after delivery

次要结局

  • To assess the efficacy of the drugs in terms of additional interventions needed and drop in haemoglobin(On admission and 24 hours after delivery)

研究者

发起方
RIMS Imphal Golden Jubilee research Initiative
申办方类型
Government medical college

研究点 (1)

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