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Clinical Trials/NCT04813874
NCT04813874WithdrawnNot Applicable

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

Brigham and Women's Hospital0 sitesStarted: July 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Fetal and Neonatal Outcomes

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts 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

Arms & Interventions

neuraxial analgesia only

Receiving neuraxial analgesia only for labor

Intervention: Nitrous Oxide (Drug)

NO2 and neuraxial analgesia

Receiving nitrous oxide and neuraxial analgesia for labor

Intervention: Nitrous Oxide (Drug)

NO2 and neuraxial analgesia

Receiving nitrous oxide and neuraxial analgesia for labor

Intervention: Neuraxial analgesia (Procedure)

Outcomes

Primary Outcomes

Fetal and Neonatal Outcomes

Time Frame: At 10 minutes following birth

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

Secondary Outcomes

  • Maternal Outcome(At Delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lawrence Ching Tsen

Principal Investigator

Brigham and Women's Hospital

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