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Gas Therapy

Nitrous Oxide + Oxygen for Induced Labor

Phase 3

Recruiting

Research Sponsored by Maimonides Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Pregnant patients with contraindications to receiving nitrous oxide

Gas-trapping conditions such as pneumothorax or small bowel obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes

Awards & highlights

Pivotal Trial

Summary

This trial will compare how well nitrous oxide and oxygen help to place a Foley balloon catheter to ripen the cervix and induce labor.

Who is the study for?

This trial is for pregnant patients who are at term or have a medical need for early delivery and require a Foley balloon catheter for cervical ripening. Participants must be able to self-administer nitrous oxide safely, speak English, and not have conditions like vitamin B12 deficiency, history of malignant hyperthermia, recent opioid use, contraindications to nitrous oxide, non-reassuring fetal heart patterns, gas-trapping conditions or be under 35 weeks gestation.

What is being tested?

The study is testing the effectiveness of using nitrous oxide (laughing gas) versus oxygen in helping with the placement of an intracervical balloon catheter used to prepare the cervix for labor induction. It's a randomized controlled trial where participants will receive either nitrous oxide or oxygen randomly.

What are the potential side effects?

Possible side effects from inhaling nitrous oxide can include nausea, vomiting, dizziness, headache and feelings of euphoria. Oxygen generally has fewer side effects but may cause dryness in nasal passages or mild discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am pregnant and cannot receive nitrous oxide due to health risks.

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I do not have conditions like trapped air in my chest or blocked intestines.

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I am asking for spinal or epidural anesthesia.

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I am currently pregnant and less than 35 weeks along.

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I am currently taking magnesium sulfate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

success rate of intracervical balloon placement

Secondary study objectives

Pain Relief

Side effects data

From 2011 Phase 4 trial • 20 Patients • NCT00967694

19%

Dysphoria

Nausea/vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Nitrous Oxide Administration

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nitrous OxideExperimental Treatment1 Intervention

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 II: OxygenPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitrous oxide

2007

Completed Phase 4

~990

0 / 5Eligibility criteria met