跳至主要内容
临床试验/CTRI/2024/08/072749
CTRI/2024/08/072749尚未招募Phase 3 4

To compare the incidence and severity of PDPH in elective cesarean sections using 25G Quincke spinal needle

Datta Meghe Institute Of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the incidence and severity of PDPH in elective cesarean sections using 25G Quincke spinal needle-[Spinal Needle]

研究概览

简要总结

This is a protocol of planning of the study title " To compare the incidence and severity of PDPH in elective cesarean sections using 25G Quincke and 27 G Quincke spinal needle."that will be conducted only after CTRI registration.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • ASA grade 1&
  • Primigravida posted for elective caesarean section, with a gestational age above 34 weeks, Patient with single uncomplicated pregnancy, Age between 20-35years.
  • Weighing 40-90kg.

排除标准

  • Patient who don’t give concent.
  • Patient with spinal abnormalities.
  • Patient hypertensive disorder of pregnancy.
  • Soft tissue infection at the needle entry site.

结局指标

主要结局

To compare the incidence and severity of PDPH in elective cesarean sections using 25G Quincke spinal needle-[Spinal Needle]

时间窗: Post assessment will be evaluated on same day after procedure, day1 ,day2, day3

次要结局

  • onset of PDPH(Up to three days)

研究者

发起方
Datta Meghe Institute Of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Renuka Patond

Datta Meghe Institute Of Higher Education & Research

研究点 (1)

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