Labor PainPhase 3NCT06498908
Intracervical Balloon Placement With Nitrous Oxide Administration
A Phase 3 study testing Nitrous oxide and Oxygen in people with Labor Pain and Induced; Birth, run by Jefferson Drapkin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Induced; Birth
- What is being tested?
- Nitrous oxide and Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Maimonides Medical Center OB/GYN
Brooklyn, New York, 11220
About this study
Official title: Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration. A Randomized Control Study
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.
Read the 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.
- Conditions
- Labor Pain, Induced; Birth
- Being tested
- Nitrous oxide, Oxygen
- Keywords
- pregnancy
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous oxideDrug
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.
OxygenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nitrous oxide |
| Oxygen | Placebo comparator | Patients in the control arm will receive an inhalant of 50% oxygen for the duration of their foley balloon placement. Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of intracervical balloon placement
successful placement of intracervical ripening ballon on first attempt
Measured: 15 minutes
Secondary outcomes (1)
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).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Mar 2026
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Why it stopped: Withdrawn due to study staff leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nitrous Oxide vs Oxygen
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jefferson Drapkin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jefferson Drapkin, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498908
- Sponsor's protocol ID
- N20A
- Status last verified
- Mar 2026
- First submitted
- 5 Jul 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration. A Randomized Control Study
- ClinicalTrials.gov ID
- NCT06498908
- Acronym / sponsor ID
- N20A
- Conditions
- Labor Pain, Induced; Birth
- Keywords
- pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to study staff leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jefferson DrapkinUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Nitrous Oxide vs Oxygen
| Arm | Type | Receives |
|---|---|---|
| Nitrous Oxide | Experimental | Drug: Nitrous oxidePatients 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 | Drug: OxygenPatients in the control arm will receive an inhalant of 50% oxygen for the duration of their foley balloon placement. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous oxideNitrous 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. | Drug | Nitrous Oxide |
| OxygenOxygen 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. | Drug | Oxygen |
Primary outcome
success rate of intracervical balloon placement
Time frame: 15 minutes
successful placement of intracervical ripening ballon on first attempt
1 secondary outcome
Pain Relief
Time frame: 15 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Labor Pain
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitrous oxide and Oxygen in people with Labor Pain and Induced; Birth, run by Jefferson Drapkin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of intracervical balloon placement (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.