ENTONOXNCT04321642
The Effect of Entonox on Stages of Labor in Nulliparous Women
A study testing Entonox and Not receive Entonox in people with ENTONOX and Nulliparous, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- ENTONOX, Nulliparous, Duration of Labor
- What is being tested?
- Entonox and Not receive Entonox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Entonox on Stages of Labor in Nulliparous Women :a Randomized Controlled Trial
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
- Conditions
- ENTONOX, Nulliparous, Duration of Labor
- Being tested
- Entonox, Not receive Entonox
- Keywords
- Entonox, Nulliiparous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntonoxDrug
Also called Entonox gas
Entonox gas with mouth piece
Not receive EntonoxDrug
Not receive any gas
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Entonox |
| Not receive Entonox | Active comparator | Not receive any gas when archive in active phase of labor( cervical dilatation more than 5 cm ) Receives: Drug: Not receive Entonox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Entonox for duration of labor
Study about duration of labor after receive Entonox in active phase of labor
Measured: 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
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Nov 2019
- Primary completion30 Nov 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ENTONOXStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Somboon sornsukulrat, MD, Study chair, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321642
- Sponsor's protocol ID
- 071
- Status last verified
- Nov 2019
- First submitted
- 8 Jan 2020
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Entonox
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Entonox on Stages of Labor in Nulliparous Women :a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04321642
- Acronym / sponsor ID
- 071
- Conditions
- ENTONOX, Nulliparous, Duration of Labor
- Keywords
- Entonox, Nulliiparous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entonox | Experimental | Drug: EntonoxInhalation 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 |
| Not receive Entonox | Active comparator | Drug: Not receive EntonoxNot receive any gas when archive in active phase of labor( cervical dilatation more than 5 cm ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Nulliparity
- Age 18 years old or more
- Gestational age 37-40+6 wks
- Singleton
- Cephalic presentation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntonoxAlso: Entonox gasEntonox gas with mouth piece | Drug | Entonox |
| Not receive EntonoxNot receive any gas | Drug | Not receive Entonox |
Primary outcome
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
1 secondary outcome
Rate of patients who inhaled Entonox for pain relieve
Time frame: up to 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No. Entonox
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somboon sornsukulrat, MD study chair
Department of Medical Services Ministry of Public Health of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entonox and Not receive Entonox in people with ENTONOX and Nulliparous, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Entonox for duration of labor (time frame: up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.