NCT06498908

Intracervical Balloon Placement With Nitrous Oxide Administration

Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration. A Randomized Control Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Olivia Sher · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 their 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.

Conditions

• Labor Pain
• Induced; Birth

Interventions

Type	Name	Description
DRUG	Nitrous oxide	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.
DRUG	Oxygen	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2024-07-12
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study