Intracervical Balloon Placement With Nitrous Oxide Administration

NCT06498908 | Recruiting Phase 3 FDA Drug

• 1 other identifier: N20A
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Induced; Birth

Keywords

pregnancy

Outcome Measures

Primary Outcomes (1)

• success rate of intracervical balloon placement

  successfull placement of intracervical ripening ballon on first attempt

  15 minutes

Secondary Outcomes (1)

• Pain Relief

  15 minutes

Study Arms (2)

Nitrous Oxide

EXPERIMENTAL

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

Oxygen

PLACEBO COMPARATOR

Patients in the control arm will receive an inhalant of 100% oxygen for the duration of their foley balloon placement.

Drug: Oxygen

Interventions

Nitrous oxide DRUG

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.

Nitrous Oxide

Oxygen DRUG

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.

Oxygen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center OB/GYN

Brooklyn, New York, 11220, United States

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Central Study Contacts

Scott Chudnoff, MD

CONTACT

718-283-9054; Schudnoff@maimo.org

Olivia Sher, MPH

CONTACT

718-283-7962; osher@maimo.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects won't be told which group they were assigned. Care providers will be told which group subject is assigned/
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Scott Chudnoff

Model Details: Nitrous Oxide vs Oxygen

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: May 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)