Intracervical Balloon Placement With Nitrous Oxide Administration

Maimonides Medical Center

Status and phase: Enrolling; Phase 3

Conditions: Induced; Birth; Labor Pain

Treatments: Drug: Nitrous oxide; Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT06498908

N20A

Details and patient eligibility

About

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.

Full description

This is a single center randomized controlled trial aimed 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. Pregnant women requiring labor induction will be randomly assigned to receive either nitrous oxide or oxygen during the Foley balloon placement. The primary outcome measured will be the success rate of the Foley balloon placement, with secondary outcomes including patient comfort, pain levels during the procedure, and any adverse effects. The study seeks to determine if nitrous oxide can improve the success rate of Foley balloon placement compared to oxygen and to evaluate the overall patient experience and safety associated with its use in this context.

Enrollment: 162 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 2 patient groups, including a placebo group

Nitrous Oxide

Experimental group

Description:

Patients in the intervention arm will receive an inhalant of 50% nitrous/50% oxygen intended to target pain relief for the duration of their foley ballon placement.

Treatment:

Drug: Nitrous oxide

Oxygen

Placebo Comparator group

Description:

Patients in the control arm will receive an inhalant of 100% oxygen for the duration of their foley balloon placement.

Treatment:

Drug: Oxygen