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Withdrawn due to study staff leaving institution
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous Oxide | Experimental | 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. |
|
| Oxygen | Placebo Comparator | Patients in the control arm will receive an inhalant of 50% oxygen for the duration of their foley balloon placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous oxide | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of intracervical balloon placement | successful placement of intracervical ripening ballon on first attempt | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | 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). | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center OB/GYN | Brooklyn | New York | 11220 | United States |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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Nitrous Oxide vs Oxygen
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Subjects won't be told which group they are assigned. Care providers will be told which group subject is assigned.
| Oxygen | 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. |
|
| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D018011 | Chalcogens |
| D004602 | Elements |