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Withdrawn NCT06498908

Intracervical Balloon Placement With Nitrous Oxide Administration

Conditions: Labor Pain, Induced; Birth

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE3
Sponsor: Jefferson Drapkin

Location: Maimonides Medical Center OB/GYN Brooklyn New York

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.

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06498908). StuddyBuddy aggregates publicly available trial information.