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临床试验/CTRI/2025/12/099727
CTRI/2025/12/099727尚未招募不适用

Comparison of intravenous carbetocin versus oxytocin infusion on hemodynamics in women undergoing elective Caesarean section in a tertiary care hospital: A prospective observational study

Kasturba Medical College and Kasturba Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月15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
80
试验地点
1

研究概览

简要总结

Postpartum hemorrhage (PPH) remains a major cause of maternal morbidity and mortality worldwide. Active management of the third stage of labor (AMTSL) with uterotonic agents such as oxytocin is the standard of care. Carbetocin, a long acting oxytocin analog, has emerged as an alternative with potential benefits, including a longer duration of action and reduced need for additional uterotonic doses.

Spinal anaesthesia, the preferred anaesthetic technique for caesarean sections, induces sympathetic blockade, leading to vasodilation and hypotension. The additional hemodynamic effects of uterotonics, such as tachycardia and hypotension, may further compromise maternal stability. However, there is limited evidence comparing the hemodynamic profiles of oxytocin and carbetocin when administered as intravenous boluses during caesarean section under spinal anaesthesia.

While oxytocin remains as the first line uterotonic agent, its administration can lead to significant hemodynamic disturbances. Carbetocin, due to its prolonged action, may reduce the need for repeated doses and the associated cardiovascular instability. A comparative evaluation of these two drugs in context of spinal anaesthesia is essential to determine the safer option in clinical practice.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • ASA Physical Status I and II
  • Singleton pregnancy (after 37 weeks)
  • No history of hypertensive disorders or cardiovascular disease.

排除标准

  • Preeclampsia or eclampsia
  • Known hypersensitivity to oxytocin or carbetocin
  • Multiple gestations
  • Placental abnormalities (placenta previa, placental abruption)
  • Severe anemia (Hb less than 7 gram percent)
  • Contraindications to spinal anesthesia (patient refusal, raised intracranial pressure, infection at the site of administration, hypersensitivity to local anaesthetic, coagulopathy, sepsis, uncorrected hypovolemia).

研究者

发起方
Kasturba Medical College and Kasturba Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Greeshma Jose

Manipal Academy of Higher Education

研究点 (1)

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