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The Effect of Entonox on Stages of Labor in Nulliparous Women

NCT ID: NCT04321642

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-08-31

Brief Summary

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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

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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

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ENTONOX Nulliparous Duration of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Entonox

Intervention Type DRUG

Entonox gas with mouth piece

Not receive Entonox

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

Group Type ACTIVE_COMPARATOR

Not receive Entonox

Intervention Type DRUG

Not receive any gas

Interventions

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Entonox

Entonox gas with mouth piece

Intervention Type DRUG

Not receive Entonox

Not receive any gas

Intervention Type DRUG

Other Intervention Names

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Entonox gas

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Somboon sornsukulrat, MD

Role: STUDY_CHAIR

Department of Medical Services Ministry of Public Health of Thailand

Locations

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Rajavithi Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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071

Identifier Type: -

Identifier Source: org_study_id