PregnancyNOLANCT04813874
Nitrous Oxide and Neuraxial Labor Analgesia Use on Maternal Fetal Outcomes
An observational study of Pregnancy, run by Brigham and Women's Hospital.
Trial summary
The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Nitrous Oxide and Neuraxial analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Jul 2018
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant patients requesting for pain relief with neuraxial analgesia and/or nitrous oxide
Who may be able to join
- Pregnant patients requesting for pain relief with neuraxial analgesia and/or nitrous oxide
- health patients with no comorbidities
- singleton, vertex gestation at term
Who cannot join
- Refuse informed consent
- evidence of anticipated fetal anomalies
- significant medical or pregnancy-related diseases
About this study
Official title: Evaluation of Maternal and Fetal Outcomes Following Nitrous Oxide and Neuraxial Labor Analgesia
The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor.
Read the detailed description
The use of nitrous oxide during labor is common in several countries including the United Kingdom, Finland, Canada, Australia and New Zealand.1, 2 The use of nitrous oxide during labor has undergone a resurgence in popularity recently in the United States and became available at Brigham and Women's hospital in August 2014.
Inhaled nitrous oxide has a rapid onset (30-50 seconds) and clearance with a half-life of about 5 minutes.3 It can be used for analgesia during the first, second and third stages of labor, as well as during post-delivery procedures such as laceration repair, manual removal of the placenta, and uterine curettage. It is also commonly used to facilitate the initiation of epidural analgesia.4 At the Brigham and Women's Hospital, a pneumatically driven gas mixer is designed to deliver a 50% oxygen and 50% nitrous oxide mixture to patients. Nitrous oxide passes readily across the placenta, and reaches equilibrium within a few minutes; the fetal maternal concentration ratio after 2 minutes of inhalation is 0.64.5 Hence, when administered at 50% concentration to the mother, the fetal concentration approximates at 32%.
Despite its long track record of maternal safety reported in numerous countries, the effect of nitrous oxide on the fetus is less well-studied. A number of studies have published data on the use of nitrous oxide for labor analgesia, including the effectiveness in labor analgesia, maternal satisfaction and maternal fetal adverse effects. Most of these studies have not identified adverse neonatal outcomes. However, these studies used Apgar scores or neonatal behavior scores as outcome measures and the quality of these studies was predominately poor.
The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor.
- Conditions
- Pregnancy
- Being tested
- Nitrous Oxide, Neuraxial analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
Nitrous Oxide Inhalational Agent
Neuraxial analgesiaProcedure or surgery
Also called Epidural placement
Epidural Labor Analgesia Placement
| Study group | Role | What they receive |
|---|---|---|
| neuraxial analgesia only | Receiving neuraxial analgesia only for labor Receives: Drug: Nitrous Oxide | |
| NO2 and neuraxial analgesia | Receiving nitrous oxide and neuraxial analgesia for labor Receives: Drug: Nitrous Oxide; Procedure: Neuraxial analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal and Neonatal Outcomes
Presence of Apgar Score < 7 (0-10)
Measured: At 1 minute following birth
Fetal and Neonatal Outcomes
Presence of Apgar Score < 7 (0-10)
Measured: At 5 minutes following birth
Fetal and Neonatal Outcomes
Presence of Apgar Score < 7 (0-10)
Measured: At 10 minutes following birth
Secondary outcomes (3)
Maternal Outcome
Visual Analogue Score (0-10)
Measured: During Labor at 90 minute intervals
Maternal Outcome
Conversion to Alternative Analgesia Method (Neuraxial or General Anesthesia)
Measured: Any Time During Labor
Maternal Outcome
Mode of Delivery (Vaginal or Cesarean Delivery)
Measured: At Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jul 2016
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Why it stopped: Difficulty obtaining advanced notification of who was wanting to use nitrous
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Ching Tsen, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813874
- Sponsor's protocol ID
- NOLA
- Acronym
- NOLA
- Status last verified
- Mar 2021
- First submitted
- 21 Jan 2017
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maternal and Fetal Outcomes Following Nitrous Oxide and Neuraxial Labor Analgesia
- ClinicalTrials.gov ID
- NCT04813874
- Acronym / sponsor ID
- NOLA / NOLA
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty obtaining advanced notification of who was wanting to use nitrous
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 24 Mar 2021 (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.
The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor.
Detailed description
The use of nitrous oxide during labor is common in several countries including the United Kingdom, Finland, Canada, Australia and New Zealand.1, 2 The use of nitrous oxide during labor has undergone a resurgence in popularity recently in the United States and became available at Brigham and Women's hospital in August 2014.
Inhaled nitrous oxide has a rapid onset (30-50 seconds) and clearance with a half-life of about 5 minutes.3 It can be used for analgesia during the first, second and third stages of labor, as well as during post-delivery procedures such as laceration repair, manual removal of the placenta, and uterine curettage. It is also commonly used to facilitate the initiation of epidural analgesia.4 At the Brigham and Women's Hospital, a pneumatically driven gas mixer is designed to deliver a 50% oxygen and 50% nitrous oxide mixture to patients. Nitrous oxide passes readily across the placenta, and reaches equilibrium within a few minutes; the fetal maternal concentration ratio after 2 minutes of inhalation is 0.64.5 Hence, when administered at 50% concentration to the mother, the fetal concentration approximates at 32%.
Despite its long track record of maternal safety reported in numerous countries, the effect of nitrous oxide on the fetus is less well-studied. A number of studies have published data on the use of nitrous oxide for labor analgesia, including the effectiveness in labor analgesia, maternal satisfaction and maternal fetal adverse effects. Most of these studies have not identified adverse neonatal outcomes. However, these studies used Apgar scores or neonatal behavior scores as outcome measures and the quality of these studies was predominately poor.
The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuraxial analgesia only | – | Drug: Nitrous OxideReceiving neuraxial analgesia only for labor |
| NO2 and neuraxial analgesia | – | Drug: Nitrous Oxide, Procedure: Neuraxial analgesiaReceiving nitrous oxide and neuraxial analgesia for labor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients requesting for pain relief with neuraxial analgesia and/or nitrous oxide
Key inclusion criteria (3 listed)
- Pregnant patients requesting for pain relief with neuraxial analgesia and/or nitrous oxide
- health patients with no comorbidities
- singleton, vertex gestation at term
Key exclusion criteria (3 listed)
- Refuse informed consent
- evidence of anticipated fetal anomalies
- significant medical or pregnancy-related diseases
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 Inhalational Agent | Drug | NO2 and neuraxial analgesia, neuraxial analgesia only |
| Neuraxial analgesiaAlso: Epidural placementEpidural Labor Analgesia Placement | Procedure or surgery | NO2 and neuraxial analgesia |
Primary outcome
Fetal and Neonatal Outcomes
Time frame: At 1 minute following birth
Presence of Apgar Score < 7 (0-10)
Fetal and Neonatal Outcomes
Time frame: At 5 minutes following birth
Presence of Apgar Score < 7 (0-10)
Fetal and Neonatal Outcomes
Time frame: At 10 minutes following birth
Presence of Apgar Score < 7 (0-10)
3 secondary outcomes
Maternal Outcome
Time frame: During Labor at 90 minute intervals
Maternal Outcome
Time frame: Any Time During Labor
Maternal Outcome
Time frame: At Delivery
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 24 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Brigham and Women's Hospital.
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 3 inclusion and 3 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Fetal and Neonatal Outcomes (time frame: At 1 minute following birth). The study lists 3 primary outcomes in all. 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 24 Mar 2021.