The Effect of Entonox on Stages of Labor in Nulliparous Women

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

Study Overview

• Status: Completed
• Conditions: Nulliparous; ENTONOX; Duration of Labor
• Intervention / Treatment: Drug: Entonox; Drug: Not receive Entonox

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Entonox gas with mouth piece; Other Names: Entonox gas
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; Not receive any gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Entonox for duration of labor	Study about duration of labor after receive Entonox in active phase of labor	up to 14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients who inhaled Entonox for pain relieve	% of patients relieve pain after inhaled Entonox , Investigators measure by visual analogue scale	up to 14 months

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Study Chair: Somboon sornsukulrat, MD, Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Entonox; Nulliiparous
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Anesthetics, Combined; Nitrous Oxide; Entonox
• Other Study ID Numbers: 071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Entonox

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No