Intracervical Balloon Placement With Nitrous Oxide Administration
Launched by MAIMONIDES MEDICAL CENTER · Jul 5, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how effective nitrous oxide (a type of laughing gas) is compared to oxygen in helping place a special balloon catheter in pregnant women. This catheter is used to help prepare the cervix for labor, which is called cervical ripening, and to induce labor when necessary. The trial is currently looking for women between the ages of 18 and 45 who are admitted for labor and delivery and are eligible for this procedure.
If you participate in this trial, you will be randomly assigned to receive either nitrous oxide or oxygen while the catheter is being placed. It’s important to note that not everyone can join; for example, women with certain health conditions, allergies, or who are less than 35 weeks pregnant cannot participate. If you are eligible and decide to join, you’ll be contributing to important research that could help improve pain management during labor. Your safety and comfort will be a top priority throughout the study.
Gender
FEMALE
Eligibility criteria
- 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.
About Maimonides Medical Center
Maimonides Medical Center is a leading healthcare institution located in Brooklyn, New York, renowned for its commitment to patient-centered care and innovative medical research. As a prominent clinical trial sponsor, Maimonides Medical Center leverages its extensive expertise and state-of-the-art facilities to advance medical knowledge and improve therapeutic outcomes. The center collaborates with a diverse team of healthcare professionals and researchers to conduct rigorous clinical trials across various specialties, ensuring adherence to the highest ethical standards and regulatory guidelines. Through its dedication to clinical excellence and community health, Maimonides Medical Center plays a vital role in translating research findings into practical, life-saving treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brooklyn, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported