NCT04321642

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2019

Enrollment Period

29 days

First QC Date

January 8, 2020

Last Update Submit

November 28, 2024

Conditions

ENTONOXNulliparousDuration of Labor

Keywords

EntonoxNulliiparous

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of patients who inhaled Entonox for pain relieve

    up to 14 months

Study Arms (2)

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

Drug: Entonox

Not receive Entonox

ACTIVE COMPARATOR

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

Drug: Not receive Entonox

Interventions

EntonoxDRUG

Entonox gas with mouth piece

Also known as: Entonox gas
Entonox
Not receive EntonoxDRUG

Not receive any gas

Not receive Entonox

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Entonox

Study Officials

  • Somboon sornsukulrat, MD

    Department of Medical Services Ministry of Public Health of Thailand

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

March 25, 2020

Study Start

November 1, 2019

Primary Completion

November 30, 2019

Study Completion

August 31, 2020

Last Updated

December 3, 2024

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Entonox

Locations

TH(1)