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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKaplan Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years

Women at ≥34 weeks of gestation

Singleton or twin pregnancy

Ability to understand, sign informed consent, and complete questionnaires

Disqualifiers

Triplet or higher-order pregnancy

Contraindications to nitrous oxide use

Fetal monitoring category 2 or higher

Maternal body temperature >38°C

Trial design

Treatments tested in this trial

  • Inhaled nitrous oxide

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kaplan Medical Center

Lead sponsor

Clalit Health Services

Collaborator

Wolfson Medical Center

Collaborator

Rabin Medical Center

Collaborator

Meir Medical Center

Collaborator