The Effect of Entonox on Stages of Labor in Nulliparous Women

Not Applicable

Completed

• Conditions: ENTONOX; Duration of Labor; Nulliparous
• Interventions: Drug: Entonox; Drug: Not receive Entonox

• Registration Number: NCT04321642
• Lead Sponsor: Rajavithi Hospital

Brief 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

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 Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-01
• Primary Completion: 2019-11-30
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-25
• Study Completion: 2020-08-31
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Effect of Entonox for duration of labor	up to 14 months	Study about duration of labor after receive Entonox in active phase of labor

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand