跳至主要内容
临床试验/NCT01236651
NCT01236651Unknown2 期

Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Ain Shams University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
200
试验地点
1
主要终点
the duration of the first stage of labor

研究概览

简要总结

Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

详细描述

Comparison Between Meperidine and Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae

Protocol of Thesis Submitted for partial fulfillment of master degree in Obstetrics & Gynecology

The aim of this work is to compare and to evaluate the efficacy of drotaverine hydrochloride versus meperidine hydrochloride on the duration of the 1st stage of labor.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

性别
Male
接受健康志愿者

入选标准

  • ● primigravida.
  • Singleton pregnancy.
  • Term gestation i.e, 38-41 weeks.
  • Sure, reliable dates documented by ultrasound in the 1st half of pregnancy.
  • Vertex presentation with occipito anterior position.
  • Efficient uterine contractions at a rate of at least 3 to 4 contractions every 10 minutes, each contraction lasting for at least 40 seconds.

排除标准

  • ● Abnormal presentation or occipito posterior position.
  • Multiple pregnancies.
  • Cephalo-pelvic disproportion.
  • Cervical surgery in the past or history of cervical injury.
  • Patients on antihypertensive therapy.
  • Known hypersensitivity to drotaverine or meperidine.
  • If any other spasmolytic agent had been used within 48 hours.

研究组 & 干预措施

meperidine and duration of 1st stage of labor

Experimental

meperidine 100mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor

干预措施: Meperidine (Drug)

drotaverine and duration of 1st stage of labor

Experimental

drotaverine 40mg i.v in 1st stage of labor and calculate the duration of the 1st stage of labor

干预措施: Drotaverine (Drug)

结局指标

主要结局

the duration of the first stage of labor

时间窗: 6 monthes

the primary outcome is to evaluate whether meperidine or drotaverine is more effective in shortening the duration of the 1st stage of labor

effect on the duration of the 1st stage of labor

时间窗: 6 monthes

the primary outcome is to evaluate whether meperidine or drotaverine is more effective on the duration of the 1st stage of labor

次要结局

  • effect on pain(6 monthes)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验