Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal

The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort and anxiety despite being a brief procedure. The study will include pregnant women aged 18 years or older undergoing elective cervical cerclage removal at 36 weeks of gestation or later. The main questions the study aims to answer are: * Does inhaled nitrous oxide reduce pain during cervical cerclage removal? * Does inhaled nitrous oxide reduce anxiety during the procedure? * Does the use of nitrous oxide improve overall patient satisfaction during cerclage removal? Researchers will compare women receiving inhaled nitrous oxide to those receiving standard care without analgesia, as routinely practiced in the participating institutions, in order to determine whether nitrous oxide improves pain control and patient experience during the procedure. Participants will: * Be randomly assigned to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) or standard care without analgesic treatment during cervical cerclage removal. * Undergo the procedure according to routine clinical practice in the participating centers. * Complete questionnaires assessing pain and anxiety, including a visual analog scale (VAS) for pain and the State-Trait Anxiety Inventory (STAI). * Have routine clinical data recorded from their medical records, including maternal vital signs and any procedure-related side effects.

NCT Number	NCT07491874
Lead Sponsor	Kaplan Medical Center Collaborators: Clalit Health Services, Wolfson Medical Center, Rabin Medical Center, Meir Medical Center
Conditions	Preterm Delivery, Cervical Cerclage, Cervical Insufficiency
Enrollment	60 participants
Start Date	2026-05-01
Primary Completion	2028-05-01 (estimated)
Study Completion	2028-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-08