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Intracervical Balloon Placement With Nitrous Oxide Administration

Intracervical Balloon Placement With Nitrous Oxide Administration

Recruiting
18-45 years
Female
Phase 3

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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.

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.

Eligibility

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 details
    Labor Pain
    Induced; Birth

NCT06498908

Maimonides Medical Center

21 October 2025

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