Nitrous Oxide + Oxygen for Induced Labor
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Maimonides Medical Center
Must not be taking: Magnesium sulfate, Opioids
Disqualifiers: Malignant hyperthermia, Vitamin B12 deficiency, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using magnesium sulfate or have used intravenous or intramuscular opioids within 4 hours before the trial.
What data supports the effectiveness of the drug nitrous oxide with oxygen for induced labor?
Research shows that nitrous oxide mixed with oxygen is effective for pain relief during labor, with most women experiencing satisfactory pain control without affecting their consciousness or the baby's health. It is a noninvasive option that has been used worldwide for over 100 years, providing a safe alternative to more invasive pain relief methods like epidurals.
12345Is nitrous oxide with oxygen safe for use during labor?
Nitrous oxide mixed with oxygen is generally considered safe for women in labor, their newborns, and healthcare workers. While there are some concerns about potential risks, such as effects on the brain and cardiovascular system, studies have shown it to be a safe option for pain management during childbirth.
46789How does the drug nitrous oxide with oxygen differ from other treatments for induced labor?
Nitrous oxide with oxygen is unique because it is a noninvasive inhaled option for pain relief during labor, unlike more common methods like epidurals or IV medications. It has been used for over 100 years in many countries, providing effective pain relief without the need for needles or significant medical intervention.
15101112Eligibility Criteria
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.Inclusion Criteria
I am pregnant and can have a balloon placed in my cervix.
Patients admitted to labor and delivery for induction of labor (term inductions, medically indicated preterm inductions)
Exclusion Criteria
Vitamin B12 deficiency
History of malignant hyperthermia
I have not used any IV or IM opioids in the last 4 hours.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive either nitrous oxide or oxygen during Foley balloon placement for cervical ripening and induction of labor
15 minutes
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 week
Participant Groups
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.
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.
Nitrous oxide is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Nitrous Oxide for:
- Procedural sedation for mild to moderate pain
- Labor analgesia
- Dental anesthesia
- Emergency department analgesia
🇪🇺 Approved in European Union as Nitrous Oxide for:
- Procedural sedation for mild to moderate pain
- Labor analgesia
- Dental anesthesia
🇨🇦 Approved in Canada as Nitrous Oxide for:
- Procedural sedation for mild to moderate pain
- Labor analgesia
- Dental anesthesia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Maimonides Medical Center OB/GYNBrooklyn, NY
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Who Is Running the Clinical Trial?
Maimonides Medical CenterLead Sponsor
References
[Clinical study: the effects of inhaling nitrous oxide for analgesia labor on pregnant women and fetus]. [2013]To investigate the effect of the inhalation of nitrous oxide premixed with oxygen (50%:50%) for analgesia labor on maternal and fetus.
[Application of nitrous oxide in labor analgesia]. [2013]Labor analgesia with nitrous oxide was studied in 34 parturients, and another 50 women taking no drug as the control group. The analgesic effect was satisfactory. By Mulleetr's pain in labor score, 91.18% women had score of 0-1, and their respiratory and circulatory functions were not affected. During inhalational analgesia the parturients remained conscious. Uterine contraction, progress of labor and neonatal Apgar score were not interferred, and postpartum bleeding was not increased. There was no complications in the treatment group. This study suggests that nitrous oxide with enough oxygen inhalation is one of the good drug for obstetric analgesia, but its concentration must be strictly controlled.
Nitrous Oxide During Labor: Maternal Satisfaction Does Not Depend Exclusively on Analgesic Effectiveness. [2018]Evidence on the analgesic effectiveness of nitrous oxide for labor pain is limited. Even fewer studies have looked at patient satisfaction. Although nitrous oxide appears less effective than neuraxial analgesia, it is unclear whether labor analgesic effectiveness is the most important factor in patient satisfaction. We sought to compare the relationship between analgesic effectiveness and patient satisfaction with analgesia in women who delivered vaginally using nitrous oxide, neuraxial analgesia (epidural or combined spinal-epidural [CSE]), or both (neuraxial after a trial of nitrous oxide).
[Clinical study on efficacy and safety of labor analgesia with inhalation of nitrous oxide in oxygen]. [2013]To investigate the efficacy and safety of labor analgesia with inhalation of 50% nitrous oxide in oxygen.
Nitrous oxide for labor analgesia. [2018]Inhaled nitrous oxide (N2O) has been used worldwide for over 100 years as labor analgesia but has not gained widespread use in the United States. Nitrous oxide provides a noninvasive option for laboring women. This article outlines its efficacy and safety as an analgesic compared with epidural and IV pain medications.
Nitrous oxide for relief of labor pain: a systematic review. [2022]A systematic review was conducted to determine the efficacy and safety of nitrous oxide for labor analgesia. Eleven randomized controlled trials with adequate control groups and outcome assessment by parturients during or shortly after the intervention were used to determine efficacy. To determine adverse outcome, descriptions found in 8 controlled trials and in 8 observational studies were included. A nonsystematic review of studies on occupational exposure was also conducted. Nitrous oxide is not a potent labor analgesic, but it is safe for parturient women, their newborns, and health care workers in attendance during its administration. It appears to provide adequately effective analgesia for many women.
Safety and risks of nitrous oxide labor analgesia: a review. [2018]This review of the safety and risks of nitrous oxide (N(2) O) labor analgesia presents results of a search for evidence of its effects on labor, the mother, the fetus, the neonate, breastfeeding, and maternal-infant bonding. Concerns about apoptotic damage to the brains of immature mammals exposed to high doses of N(2) O during late gestation, possible cardiovascular risks from hyperhomocysteinemia caused by N(2) O, a hypothesis that children exposed to N(2) O during birth are more likely to become addicted to amphetamine drugs as adults, and possible occupational risks for those who provide care to women using N(2) O/O(2) labor analgesia are discussed in detail.
Nitrous Oxide for Labor Analgesia: What We Know to Date. [2021]Background: Although nitrous oxide (N2O) has been used since the 1880s for labor analgesia, its popularity has only recently increased in the United States. In 2011, only 3 centers in the country offered N2O, but as of 2020, several hundred labor units have adopted its use. Methods: We reviewed the literature and summarize the mechanism of action, clinical uses, and efficacy of N2O for labor analgesia, as well as patient satisfaction related to its use. Results: N2O has several proposed mechanisms of action that make it a viable option for all 3 stages of labor and postpartum procedures. N2O has been shown to be a safe option for both mom and baby during labor and delivery. Studies support N2O as an analgesic for laboring. Even though 40% to 60% of women who use N2O convert to a labor epidural analgesia, satisfaction surveys indicate that analgesia is not the only factor contributing to the use of N2O during labor. Conclusion: The use of N2O has increased in labor and delivery units across the United States since 2011. Despite inferior analgesic properties compared to epidural analgesia, N2O offers a safe alternative for many parturients who want a greater sense of control and mobility.
Initiating Intrapartum Nitrous Oxide in an Academic Hospital: Considerations and Challenges. [2018]A 50%-50% mixture of nitrous oxide and oxygen has long been used for managing pain during labor in many countries, but only recently has this intrapartum analgesic technique become popular in the United States. Nitrous oxide is considered minimal sedation and a safe pain management alternative. Many facilities are now interested in providing laboring women this analgesic option. The process of establishing use of nitrous oxide in a large institution can be complicated and may seem daunting. This brief report describes the challenges that occurred during the process of initiating nitrous oxide for pain management during childbirth at an academic medical center and discusses various committee roles. Nurses at the University of New Mexico Hospital now directly oversee the administration of nitrous oxide to women in labor in accordance to an established guideline. Despite limited available research, the guideline also allows offering nitrous oxide as a pain management technique for women with opioid dependence. Key components of the guideline and specifics related to education, cost, and safety are reviewed.
Nitrous oxide for labor analgesia: expanding analgesic options for women in the United States. [2022]Nitrous oxide (N2O) is a commonly used labor analgesic in many Western countries, but is used infrequently in the United States. The University of California at San Francisco has been offering N2O for labor analgesia for more than 30 years. Vanderbilt University Medical Center recently began offering N2O as an option for pain relief in laboring women. Many women report that N2O provides effective pain relief during labor and argue that it should be made more widely available in the United States. This article discusses the use of N2O for pain management during labor, including its history, properties, clinical indications, and use and environmental safety issues. Practical issues regarding implementation of N2O service in a medical center setting are also discussed.
A controlled oximetric evaluation of inhalational, opioid and epidural analgesia in labour. [2019]The effects on patient oxygenation of nitrous oxide, narcotic and epidural analgesia in labour were evaluated using pulse oximetry. Five groups of ten patients received either no analgesia (Control, Group 1), an epidural block alone (Group 2), nitrous oxide in oxygen alone (Group 3), intramuscular pethidine (Group 4), or nitrous oxide in oxygen combined with intramuscular pethidine (Group 5). Derived parameters included the maximum (MAX), minimum (MIN), average maximum (AV MAX), and average minimum (AV MIN) arterial haemoglobin oxygen saturation (SaO2), and differences between maxima and minima (MAX-MIN). There was a statistically significant difference between Group 1 and Group 5 for MIN, AV MIN and MAX-MIN SaO2 (P less than 0.05). All other groups showed no significant difference in any parameter when compared with the control group. The results are discussed with reference to normal and disordered maternal physiological changes in pregnancy. It is suggested that nitrous oxide should not be used for analgesia in labour where there is concern about maternal, placental or foetal reserve.
Phase behaviour of premixed 0.25% isoflurane in 50% nitrous oxide and 50% oxygen. [2019]Isoflurane (0.25%) in premixed nitrous oxide and oxygen 50/50, v/v, (IN(2)O), has been suggested for pain relief in labour.