Intracervical Balloon Placement With Nitrous Oxide Administration

Last updated: July 5, 2024
Sponsor: Maimonides Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

Acute Pain

Treatment

Nitrous oxide

Oxygen

Clinical Study ID

NCT06498908
N20A
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 162
Treatment Group(s): 2
Primary Treatment: Nitrous oxide
Phase: 3
Study Start date:
May 15, 2024
Estimated Completion Date:
September 01, 2025

Study 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.

Connect with a study center

  • Maimonides Medical Center OB/GYN

    Brooklyn, New York 11220
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.