Nitrous Oxide and Neuraxial Labor Analgesia Use on Maternal Fetal Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-07-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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neuraxial analgesia only

Receiving neuraxial analgesia only for labor

Nitrous Oxide

Intervention Type DRUG

Nitrous Oxide Inhalational Agent

NO2 and neuraxial analgesia

Receiving nitrous oxide and neuraxial analgesia for labor

Nitrous Oxide

Intervention Type DRUG

Nitrous Oxide Inhalational Agent

Neuraxial analgesia

Intervention Type PROCEDURE

Epidural Labor Analgesia Placement

Interventions

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Nitrous Oxide

Nitrous Oxide Inhalational Agent

Intervention Type DRUG

Neuraxial analgesia

Epidural Labor Analgesia Placement

Intervention Type PROCEDURE

Other Intervention Names

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Epidural placement

Eligibility Criteria

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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