Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04813874 |
| Other study ID # |
NOLA |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2016 |
| Est. completion date |
July 1, 2018 |
Study information
| Verified date |
March 2021 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
