The Effect of Entonox on Stages of Labor in Nulliparous Women

Duration of Labor Clinical Trial

Official title:

The Effect of Entonox on Stages of Labor in Nulliparous Women :a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321642
• Other study ID #: 071
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: January 2020
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Duration of Labor
• ENTONOX
• Nulliparous

Intervention

Drug:
• Entonox
Entonox gas with mouth piece
• Not receive Entonox
Not receive any gas

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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