Intracervical Balloon Placement With Nitrous Oxide Administration

Jefferson Drapkin

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Conditions

Labor Pain Induced; Birth

Interventions

Nitrous oxideDRUG

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.

OxygenDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Maimonides Medical Center OB/GYN

Brooklyn, New York, United States

Outcomes

Primary Outcomes

success rate of intracervical balloon placement

successful placement of intracervical ripening ballon on first attempt

Time frame: 15 minutes

Secondary Outcomes

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).

Time frame: 15 minutes

Data from ClinicalTrials.gov

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