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Nitrous Oxide and Neuraxial Labor Analgesia Use on Maternal Fetal Outcomes

Evaluation of Maternal and Fetal Outcomes Following Nitrous Oxide and Neuraxial Labor Analgesia

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04813874
Acronym
NOLA
Enrollment
0
Registered
2021-03-24
Start date
2016-07-01
Completion date
2018-07-01
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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.

Detailed description

The use of nitrous oxide during labor is common in several countries including the United Kingdom, Finland, Canada, Australia and New Zealand.1, 2 The use of nitrous oxide during labor has undergone a resurgence in popularity recently in the United States and became available at Brigham and Women's hospital in August 2014. Inhaled nitrous oxide has a rapid onset (30-50 seconds) and clearance with a half-life of about 5 minutes.3 It can be used for analgesia during the first, second and third stages of labor, as well as during post-delivery procedures such as laceration repair, manual removal of the placenta, and uterine curettage. It is also commonly used to facilitate the initiation of epidural analgesia.4 At the Brigham and Women's Hospital, a pneumatically driven gas mixer is designed to deliver a 50% oxygen and 50% nitrous oxide mixture to patients. Nitrous oxide passes readily across the placenta, and reaches equilibrium within a few minutes; the fetal maternal concentration ratio after 2 minutes of inhalation is 0.64.5 Hence, when administered at 50% concentration to the mother, the fetal concentration approximates at 32%. Despite its long track record of maternal safety reported in numerous countries, the effect of nitrous oxide on the fetus is less well-studied. A number of studies have published data on the use of nitrous oxide for labor analgesia, including the effectiveness in labor analgesia, maternal satisfaction and maternal fetal adverse effects. Most of these studies have not identified adverse neonatal outcomes. However, these studies used Apgar scores or neonatal behavior scores as outcome measures and the quality of these studies was predominately poor. The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor.

Interventions

DRUGNitrous Oxide

Nitrous Oxide Inhalational Agent

Epidural Labor Analgesia Placement

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Fetal and Neonatal OutcomesAt 1 minute following birthPresence of Apgar Score \< 7 (0-10)

Secondary

MeasureTime frameDescription
Maternal OutcomeDuring Labor at 90 minute intervalsVisual Analogue Score (0-10)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026