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

Starting soon · Not applicable

Conditions studied: Preterm Delivery, Cervical Cerclage, Cervical Insufficiency

In brief

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.

Key facts

Study ID

NCT07491874

Run by

Kaplan Medical Center

People needed

60

Starts

2026-05-01

Expected to finish

2028-05-01

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Women at ≥34 weeks of gestation
• Singleton or twin pregnancy
• Ability to understand, sign informed consent, and complete questionnaires

You may not qualify if…

• Triplet or higher-order pregnancy
• Contraindications to nitrous oxide use
• Fetal monitoring category 2 or higher
• Maternal body temperature >38°C
• Significant vaginal bleeding
• Severe preeclampsia
• Cerclage removal under general anesthesia
• Language or cognitive barrier
• Baseline pain >3 on VAS scale, prior to the procedure

Where it is running

• Kaplan Medical Center — Rehovot, Central District, Israel
• Edith Wolfson Medical Center — Holon, Israel
• Meir Medical Center — Kfar Saba, Israel
• Rabin Medical Center — Petah Tikva, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.