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临床试验/NCT04321642
NCT04321642已完成不适用

The Effect of Entonox on Stages of Labor in Nulliparous Women :a Randomized Controlled Trial

Rajavithi Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Effect of Entonox for duration of labor

研究概览

简要总结

This Trial study about The effect of Entonox associated with duration of labor in Active phase and efficacy for relief pain of labor .So investigators start to study up to 14 months

详细描述

Investigators will enroll participants in 2 groups by randomized . First group will inhale Entonox and the second group not receive any gas . The participants in Entonox group will inhale gas in 4-5 times for each uterine contraction and Nurse will measure blood pressure , O2 saturation ,pain score before use gas . The outcome,investigators study about Apgar score , duration of labor , pain relief in both group,route of delivery and estimated blood loss

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
Single (Participant)

入排标准

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

入选标准

  • Nulliparity
  • Age 18 years old or more
  • Gestational age 37-40+6 wks
  • Singleton
  • Cephalic presentation
  • Cervical dilatation > 5 cm
  • Estimated fetal weight 2,500-4,000 gm

排除标准

  • Estimated fetal weight more than 4,000 gm
  • High risk pregnancy (Hypertension in pregnancy ,Endocrine disorder , autoimmune disorder , epilsepsy etc)
  • SpO2 < 95 %
  • Contraindication for Entonox usage ( Severe head injury , asthma , Pulmonary disease,Otitis media )
  • Drug allergy : Metoclopramide , Dimenhydrinate , Pethidine ,Entonox

研究组 & 干预措施

Entonox

Experimental

Inhalation Entonox in active phase of labor ( cervical dilatation more than 5 cm ) Inhaled Entonox before true uterine contraction in 30 sec , inhaled in 4-5 times for 1 contraction

干预措施: Entonox (Drug)

Not receive Entonox

Active Comparator

Not receive any gas when archive in active phase of labor( cervical dilatation more than 5 cm )

干预措施: Not receive Entonox (Drug)

结局指标

主要结局

Effect of Entonox for duration of labor

时间窗: up to 14 months

Study about duration of labor after receive Entonox in active phase of labor

次要结局

  • Rate of patients who inhaled Entonox for pain relieve(up to 14 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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