跳至主要内容
临床试验/CTRI/2024/12/078621
CTRI/2024/12/078621尚未招募4 期

The minimum Effective Dose of Carbetocin In Preventing Postpartum Hemorrhage In Cesarean Delivery : A Factorial Randomized Controlled Trial.

Aarupadai veedu medical college and hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月17日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To determine the minimum dose of carbetocin to achieve effective uterine contraction.

研究概览

简要总结

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality and morbidity. Most common cause of PPH is failure of adequate uterine contractions or uterine anomalies. Administration of uterotonic drugs during cesarean section diminishes the risk of PPH. Carbetocin is a synthetic analogue of oxytocin with 4-10 times longer half life than oxytocin and it is heat stable.  The recommended dose of Carbetocin is 100mcg IV by SOGC as uterotonic in cesarean deliveries. Am doing a study to find the least  dose of carbetocin that can produce effective and satisfactory uterine contractions in parturients undergoing cesarean section under spinal anaesthesia. They are allotted into five groups to receive five different doses of carbetocin namely Group A 100mcg, Group B 80mcg, Group C 60mcg, Group D 40mcg, Group E 20mcg.The obstetrician will assess the uterine contraction as satisfactory or unsatisfactory at 2minutes, 5minutes, 10minutes after carbetocin administration. If at 5minutes uterine contraction is inadequate , the patient will be managed according to FIGO Recommendations 2022.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Parturients undergoing cesarean section under spinal anaesthesia.
  • ASA II AND III physical status.

排除标准

  • Patient Refusal Parturients who are having conditions predisposing to PPH Twin pregnancy, Abnormal placenta, Pre eclampsia, Advanced maternal age more than 35years, BMI more than 35Kg/m2, Anemia Hb less than 8gm%.

结局指标

主要结局

To determine the minimum dose of carbetocin to achieve effective uterine contraction.

时间窗: 2minutes, 5minutes, 10minutes

次要结局

  • To assess intraoperative blood loss and blood loss in 24 hours across various doses of carbetocin.(To assess additional requirements of uterotonic agents from delivery up to 24 hours post surgery.)

研究者

发起方
Aarupadai veedu medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Riya Abraham

Aarupadai veedu medical college and hospital

研究点 (1)

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