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临床试验/NCT01817829
NCT01817829已完成3 期

Oral Paracetamol as Preemptive Analgesia for Labor Pain

Ain Shams University0 个研究点目标入组 100 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
100
主要终点
Efficacy

研究概览

简要总结

It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

详细描述

It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • primigravida
  • The gestational age between 37- 42 weeks
  • Not seeking analgesia
  • Singleton pregnancy
  • Spontaneous onset of labour
  • 1st stage of labour (less than 5 cm)

排除标准

  • Extreme of age (below18-above 40)
  • Multiparous
  • Multiple gestation
  • Malpresentation
  • Congenital or acquired pelvic abnormalities(eg. Poliomyelitis)
  • Any medical disorder with pregnancy
  • Induction of labour
  • Advanced 1st stage > 5 cm
  • Use of any other kind of analgesia before recruitment in the study
  • Scared uterus
  • Fetal distress

研究组 & 干预措施

paracetamol

Active Comparator

paracetamol 2 tablets1000mg PO.

干预措施: paracetamol (Drug)

placebo

Placebo Comparator

placebo 2 tablets containing Starch PO

干预措施: placebo (Drug)

结局指标

主要结局

Efficacy

时间窗: intrapartum

To document the efficacy of oral paracetamol, in pregnant women in labor, as demonstrated by the degree of pain relief and need for additional analgesia during the labor process and the early postpartum period.

次要结局

  • Safety(Start of medication till 24 hours postpartum)
  • Duration of labor(Start of medication till delivery of fetus.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Elsayed Hassan Elbohoty

Dr

Ain Shams University

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