Induced; Birth, Labor Pain
Conditions
Keywords
pregnancy
Brief 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.
Detailed 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 their 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.
Interventions
DRUGNitrous 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.
DRUGOxygen
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.
Sponsors
Jefferson Drapkin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Subjects won't be told which group they are assigned. Care providers will be told which group subject is assigned.
Intervention model description
Nitrous Oxide vs Oxygen
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success rate of intracervical balloon placement | 15 minutes | successful placement of intracervical ripening ballon on first attempt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief | 15 minutes | Patients reported a pain score of a three or less on the Visual Analog Scale (VAS) for the duration of the procedure. Scores range from 0 (no pain) to 10 (extreme pain). |
Countries
United States
Outcome results
None listed