RECRUITING

Intracervical Balloon Placement With Nitrous Oxide Administration

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Conditions

Labor PainInduced; Birthpregnancy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration. A Randomized Control Study

Quick Facts

Study Start:2024-05-15
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06498908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients admitted to labor and delivery for induction of labor (term inductions, medically indicated preterm inductions).
  2. * Pregnant patients who are eligible for intracervical balloon placement.
  1. * Pregnant patients with contraindications to receiving nitrous oxide.
  2. * Inability to safely self-administer nitrous oxide
  3. * Allergy to nitrous oxide
  4. * History of malignant hyperthermia,
  5. * Concomitant administration of magnesium sulfate
  6. * Less than 35 weeks gestational age
  7. * Non-reassuring fetal heart tracing
  8. * Use of intravenous or intramuscular opioid within 4 hours
  9. * Vitamin B12 deficiency
  10. * Gas-trapping conditions such as pneumothorax or small bowel obstruction
  11. * Patients requesting neuraxial anesthesia
  12. * Non-English speaking patients.

Contacts and Locations

Study Contact

Scott Chudnoff, MD
CONTACT
718-283-9054
Schudnoff@maimo.org
Olivia Sher, MPH
CONTACT
718-283-7962
osher@maimo.org

Study Locations (Sites)

Maimonides Medical Center OB/GYN
Brooklyn, New York, 11220
United States

Collaborators and Investigators

Sponsor: Maimonides Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-15
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2025-09-01

Terms related to this study

Keywords Provided by Researchers

  • pregnancy

Additional Relevant MeSH Terms

  • Labor Pain
  • Induced; Birth