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