Using nitrous oxide to help with labor induction
Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration. A Randomized Control Study
PHASE3 · Maimonides Medical Center · NCT06498908
This study is testing if using nitrous oxide during labor induction can help pregnant women feel more comfortable and make it easier to place a Foley balloon catheter.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Maimonides Medical Center (other) |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT06498908 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares the effectiveness of nitrous oxide versus oxygen in facilitating the placement of a Foley balloon catheter for cervical ripening and labor induction in pregnant women. Participants will be randomly assigned to receive either nitrous oxide or oxygen during the procedure. The primary outcome will be the success rate of the Foley balloon placement, while secondary outcomes will assess patient comfort, pain levels, and any adverse effects. The study aims to determine if nitrous oxide can enhance the success of the procedure and improve the overall patient experience.
Who should consider this trial
Good fit: Ideal candidates are pregnant women admitted for labor induction who are eligible for intracervical balloon placement.
Not a fit: Patients with contraindications to nitrous oxide or those who cannot safely self-administer it may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved labor induction experiences and outcomes for pregnant women.
How similar studies have performed: Other studies have explored the use of nitrous oxide in labor settings, indicating potential benefits, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brooklyn, New York
- Maimonides Medical Center OB/GYN — Brooklyn, New York, United States (RECRUITING)
Study contacts
- Study coordinator: Scott Chudnoff, MD
- Email: Schudnoff@maimo.org
- Phone: 718-283-9054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Labor Pain, Induced, Birth, pregnancy