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NCT Number: NCT06498908

Intracervical Balloon Placement With Nitrous Oxide Administration

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.

Why the study stopped: Withdrawn due to study staff leaving institution
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Key information

Conditions

Labor Pain Induced; Birth Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Maimonides Medical Center OB/GYN

Brooklyn, New York, 11220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. success rate of intracervical balloon placement

    Time frame: 15 minutes

    successful placement of intracervical ripening ballon on first attempt

Secondary outcomes

  1. Pain Relief

    Time frame: 15 minutes

    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).

Sponsors and collaborators

Lead sponsor

Jefferson Drapkin

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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