NCT04813874

Brief Summary

The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

January 21, 2017

Last Update Submit

March 23, 2021

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (3)

  • Fetal and Neonatal Outcomes

    Presence of Apgar Score \< 7 (0-10)

    At 1 minute following birth

  • Fetal and Neonatal Outcomes

    Presence of Apgar Score \< 7 (0-10)

    At 5 minutes following birth

  • Fetal and Neonatal Outcomes

    Presence of Apgar Score \< 7 (0-10)

    At 10 minutes following birth

Secondary Outcomes (3)

  • Maternal Outcome

    During Labor at 90 minute intervals

  • Maternal Outcome

    Any Time During Labor

  • Maternal Outcome

    At Delivery

Study Arms (2)

neuraxial analgesia only

Receiving neuraxial analgesia only for labor

Drug: Nitrous Oxide

NO2 and neuraxial analgesia

Receiving nitrous oxide and neuraxial analgesia for labor

Drug: Nitrous OxideProcedure: Neuraxial analgesia

Interventions

Nitrous OxideDRUG

Nitrous Oxide Inhalational Agent

NO2 and neuraxial analgesianeuraxial analgesia only
Neuraxial analgesiaPROCEDURE

Epidural Labor Analgesia Placement

Also known as: Epidural placement
NO2 and neuraxial analgesia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients requesting for pain relief with neuraxial analgesia and/or nitrous oxide

You may qualify if:

  • Pregnant patients requesting for pain relief with neuraxial analgesia and/or nitrous oxide
  • health patients with no comorbidities
  • singleton, vertex gestation at term

You may not qualify if:

  • Refuse informed consent
  • evidence of anticipated fetal anomalies
  • significant medical or pregnancy-related diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2017

First Posted

March 24, 2021

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share