Intracervical Balloon Placement With Nitrous Oxide Administration

Phase 3

Recruiting

• Conditions: Induced; Birth; Labor Pain
• Interventions: Drug: Nitrous oxide; Drug: Oxygen

• Registration Number: NCT06498908
• Lead Sponsor: Maimonides Medical Center

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 induction of labor.

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 ripening and induction of labor. Pregnant women requiring labor induction will be randomly assigned to receive either nitrous oxide or oxygen during the Foley balloon placement. The primary outcome measured will be the success rate of the Foley balloon placement, with secondary outcomes including patient comfort, pain levels during the procedure, and any adverse effects. The study seeks to determine if nitrous oxide can improve the success rate of Foley balloon placement compared to oxygen and to evaluate the overall patient experience and safety associated with its use in this context.

Study Timeline

• Study Start: 2024-05-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nitrous Oxide	Nitrous oxide	Patients in the intervention arm will receive an inhalant of 50% nitrous/50% oxygen intended to target pain relief for the duration of their foley ballon placement.
Oxygen	Oxygen	Patients in the control arm will receive an inhalant of 100% oxygen for the duration of their foley balloon placement.

Primary Outcome Measures

Name	Time	Method
success rate of intracervical balloon placement	15 minutes	successfull placement of intracervical ripening ballon on first attempt

Secondary Outcome Measures

Name	Time	Method
Pain Relief	15 minutes	Patients reported a pain score of a three or less for the duration of the procedure

Trial Locations

Locations (1)

Maimonides Medical Center OB/GYN; 🇺🇸 Brooklyn, New York, United States