WithdrawnPhase 3

Intracervical Balloon Placement With Nitrous Oxide Administration

Stopped: Withdrawn due to study staff leaving institution

United States0Started 2026-03-01

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

success rate of intracervical balloon placement

Timeframe: 15 minutes

Trial details

NCT IDNCT06498908

SponsorOlivia Sher

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-30

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