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Stopped: Withdrawn due to study staff leaving institution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 range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Labor Pain trials