Intracervical Balloon Placement With Nitrous Oxide Administration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Labor Pain Induced; Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Nitrous Oxide vs Oxygen

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Subjects won't be told which group they were assigned. Care providers will be told which group subject is assigned/

Study Groups

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Nitrous Oxide

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.

Group Type EXPERIMENTAL

Nitrous oxide

Intervention Type DRUG

Nitrous oxide, commonly known as laughing gas, is a colorless, non-flammable gas with a slightly sweet odor, used for its analgesic and anesthetic properties in medical and dental procedures to provide pain relief and sedation.

Oxygen

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

Group Type PLACEBO_COMPARATOR

Oxygen

Intervention Type DRUG

Oxygen is a colorless, odorless gas essential for human respiration and used medically to treat conditions resulting from low oxygen levels in the blood. In this trial Oxygen is being used as a placebo.

Interventions

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Nitrous oxide

Nitrous oxide, commonly known as laughing gas, is a colorless, non-flammable gas with a slightly sweet odor, used for its analgesic and anesthetic properties in medical and dental procedures to provide pain relief and sedation.

Intervention Type DRUG

Oxygen

Oxygen is a colorless, odorless gas essential for human respiration and used medically to treat conditions resulting from low oxygen levels in the blood. In this trial Oxygen is being used as a placebo.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes