ClinicalTrials.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

In context

Lead sponsor

Rajavithi Hospital is the lead sponsor of 46 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , disorder , epilsepsy etc)
  • SpO2 \< 95 %
  • for Entonox usage ( Severe head injury , asthma , Pulmonary disease,Otitis media )
  • Drug allergy : Metoclopramide , Dimenhydrinate , Pethidine ,Entonox
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

  • Entonox gas with mouth piece

    Also known as: Entonox gas

  • DrugNot receive Entonox

    Not receive any gas

06

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

07

Study locations

1 site
  • Rajavithi Hospital
    Bangkok, 10400, Thailand
08

References and documents

Individual participant data

Plan to share: No — Entonox

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2019 to primary completion in Nov 2019, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2020
First posted
Mar 25, 2020
StartActual
Nov 1, 2019
Primary completionActual
Nov 30, 2019
CompletionActual
Aug 31, 2020
Last update
Dec 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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Studies of the drug tested here: Entonox

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