The Effect of Entonox on Stages of Labor in Nulliparous Women

Overview

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

Full Title of Study: “The Effect of Entonox on Stages of Labor in Nulliparous Women :a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: October 1, 2020

Detailed Description

Investigators will enroll participants in 2 groups by randomized . First group will inhale Entonox and the second group will inhale Oxygen . The participants will inhale gas (Entonox or Oxygen) 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

Interventions

  • Drug: Entonox
    • Entonox gas with mouth piece
  • Drug: oxygen gas
    • Oxygen gas with mouth piece

Arms, Groups and Cohorts

  • Experimental: Entonox
    • 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
  • Active Comparator: Oxygen gas
    • Inhalation oxygen gas in active phase of labor ( cervical dilatation more than 5 cm ) Inhaled oxygen gas before true uterine contraction in 30 sec , inhaled in 4-5 times for 1 contraction

Clinical Trial Outcome Measures

Primary Measures

  • Effect of Entonox for duration of labor
    • Time Frame: up to 14 months
    • Study about duration of labor after receive Entonox in active phase of labor

Secondary Measures

  • Rate of patients who inhaled Entonox for pain relieve
    • Time Frame: up to 14 months
    • % of patients relieve pain after inhaled Entonox , Investigators measure by visual analogue scale

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Gender Eligibility: Female

Pregnant women

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rajavithi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Somboon sornsukulrat, MD, Study Chair, Rajavithi Hospital
  • Overall Contact(s)
    • Siboonluk Lukkhan, MD, 66849945145, dr_seraph@hotmail.com

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