Status:
RECRUITING
Intracervical Balloon Placement With Nitrous Oxide Administration
Lead Sponsor:
Maimonides Medical Center
Conditions:
Labor Pain
Induced; Birth
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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 inducti...
Detailed Description
This is a single center randomized controlled trial aimed to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06498908
Start Date
May 15 2024
End Date
September 1 2025
Last Update
July 12 2024
Active Locations (1)
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1
Maimonides Medical Center OB/GYN
Brooklyn, New York, United States, 11220