Intracervical Balloon Placement With Nitrous Oxide Administration
Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration. A Randomized Control Study
Maimonides Medical Center
162 participants
May 15, 2024
INTERVENTIONAL
Conditions
Summary
This randomized controlled trial aims to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor.
Eligibility
Inclusion Criteria2
- Patients admitted to labor and delivery for induction of labor (term inductions, medically indicated preterm inductions).
- Pregnant patients who are eligible for intracervical balloon placement.
Exclusion Criteria12
- Pregnant patients with contraindications to receiving nitrous oxide.
- Inability to safely self-administer nitrous oxide
- Allergy to nitrous oxide
- History of malignant hyperthermia,
- Concomitant administration of magnesium sulfate
- Less than 35 weeks gestational age
- Non-reassuring fetal heart tracing
- Use of intravenous or intramuscular opioid within 4 hours
- Vitamin B12 deficiency
- Gas-trapping conditions such as pneumothorax or small bowel obstruction
- Patients requesting neuraxial anesthesia
- Non-English speaking patients.
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Interventions
Nitrous oxide, commonly known as laughing gas, is a colorless, non-flammable gas with a slightly sweet odor, used for its analgesic and anesthetic properties in medical and dental procedures to provide pain relief and sedation.
Oxygen is a colorless, odorless gas essential for human respiration and used medically to treat conditions resulting from low oxygen levels in the blood. In this trial Oxygen is being used as a placebo.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06498908