Intracervical Balloon Placement With Nitrous Oxide Administration

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Labor Pain, Induced; Birth

In brief

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.

Key facts

Study ID

NCT06498908

Run by

Olivia Sher

People needed

0

Starts

2026-03-01

Expected to finish

2026-03-30

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Maimonides Medical Center OB/GYN — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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