Intracervical Balloon Placement With Nitrous Oxide Administration

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Labor Pain; Induced; Birth
• Intervention / Treatment: Drug: Nitrous oxide; Drug: Oxygen

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11220
      • Maimonides Medical Center OB/GYN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: Oxygen; Patients in the control arm will receive an inhalant of 50% oxygen for the duration of their foley balloon placement.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of intracervical balloon placement	successful placement of intracervical ripening ballon on first attempt	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief	Patients reported a pain score of a three or less on the Visual Analog Scale (VAS) for the duration of the procedure. Scores range from 0 (no pain) to 10 (extreme pain).	15 minutes

Collaborators and Investigators

• Sponsor: Olivia Sher

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain; Inorganic Chemicals; Nitrogen Compounds; Elements; Oxides; Oxygen Compounds; Chalcogens; Gases; Nitrogen Oxides; Nitrous Oxide; Oxygen
• Other Study ID Numbers: N20A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No