CClinicalTrials.gg
CompletedNCT04321642Updated Dec 3, 2024

The Effect of Entonox on Stages of Labor in Nulliparous Women

An interventional study of Entonox and Not receive Entonox in ENTONOX, Nulliparous and Duration of Labor, sponsored by Rajavithi Hospital. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Rajavithi Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • ENTONOX
  • Nulliparous
  • Duration of Labor

Keywords

  • Entonox
  • Nulliiparous
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • 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

    Drug: Entonox

  • Active comparator
    Not receive Entonox

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

    Drug: Not receive Entonox

Interventions

  • DrugEntonox

    Entonox gas with mouth piece

    Also known as: Entonox gas

  • DrugNot receive Entonox

    Not receive any gas

05

What researchers measure

Primary outcomes

  1. Effect of Entonox for duration of labor

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

    Time frame: up to 14 months

Secondary outcomes

  1. Rate of patients who inhaled Entonox for pain relieve

    % of patients relieve pain after inhaled Entonox , Investigators measure by visual analogue scale

    Time frame: up to 14 months

06

Study locations

1 site
  • Rajavithi Hospital
    Bangkok, 10400, Thailand
07

References and documents

Individual participant data

Plan to share: No — Entonox

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04321642
Lead sponsor
Rajavithi Hospital
Responsible party
Sponsor
First posted
Mar 25, 2020
Start date
Nov 1, 2019
Primary completion
Nov 30, 2019
Completion
Aug 31, 2020
Last update
Dec 3, 2024

Study contacts

Somboon sornsukulrat, MD
study chair · Rajavithi Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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