Nitrous Oxide and Neuraxial Labor Analgesia Use on Maternal Fetal Outcomes
- Registration Number
- NCT04813874
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- Pregnant patients requesting for pain relief with neuraxial analgesia and/or nitrous oxide
- health patients with no comorbidities
- singleton, vertex gestation at term
- Refuse informed consent
- evidence of anticipated fetal anomalies
- significant medical or pregnancy-related diseases
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NO2 and neuraxial analgesia Neuraxial analgesia Receiving nitrous oxide and neuraxial analgesia for labor neuraxial analgesia only Nitrous Oxide Receiving neuraxial analgesia only for labor NO2 and neuraxial analgesia Nitrous Oxide Receiving nitrous oxide and neuraxial analgesia for labor
- Primary Outcome Measures
Name Time Method Fetal and Neonatal Outcomes At 10 minutes following birth Presence of Apgar Score \< 7 (0-10)
- Secondary Outcome Measures
Name Time Method Maternal Outcome At Delivery Mode of Delivery (Vaginal or Cesarean Delivery)