[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630761":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":33,"responsibleParty":86,"collaborators":89,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":18,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":18,"enrollmentInfo":106,"targetDuration":18,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":18,"overallStatus":117,"whyStopped":18,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Kaplan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inhaled Nitrous Oxide During Cervical Cerclage Removal","EXPERIMENTAL","Participants in this arm will receive inhaled nitrous oxide (50% nitrous oxide \u002F 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The equipment is identical to the device routinely used for labor analgesia in the participating institutions and will be operated and monitored by trained midwives experienced in nitrous oxide administration.\n\nContinuous pulse oximetry monitoring will be initiated prior to gas administration. Nitrous oxide inhalation will begin following instruction from the performing physician, and the procedure will start approximately three minutes after inhalation begins once adequate analgesia and anxiolysis are achieved. After completion of the procedure, nitrous oxide will be discontinued and the patient will breathe room air. The patient will remain in bed for approximately 15 minutes with fetal monitoring to conf",[13],"Drug: Inhaled nitrous oxide",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Without Analgesia","NO_INTERVENTION","Participants in this arm will undergo cervical cerclage removal without analgesia, in accordance with the standard practice across the participating institutions. The procedure will be performed in the outpatient setting following routine clinical protocols. Maternal vital signs and fetal status will be monitored according to standard clinical practice. No nitrous oxide or other analgesic intervention will be administered as part of the study protocol.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Inhaled nitrous oxide","Inhaled nitrous oxide (50% nitrous oxide \u002F 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The device is identical to the equipment routinely used for labor analgesia in the participating institutions and is operated and monitored by trained midwives experienced in nitrous oxide administration.\n\nNitrous oxide inhalation begins following instruction from the performing physician. The procedure starts approximately three minutes after inhalation begins, once adequate analgesia and anxiolysis are achieved. Continuous pulse oximetry monitoring is performed during administration. After completion of the procedure, nitrous oxide is discontinued and the patient breathes room air.",[9],[26],"N2O",[28],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Gil Friedman","CONTACT","+972584744356","gilfriedman51@gmail.com",[34,48,61,74],{"facility":5,"status":18,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Rehovot","Central District","7639302","Israel","IL",{"type":41,"coordinates":42},"Point",[43,44],34.81199,31.89421,{"lat":44,"lon":43},[47],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},{"facility":49,"status":18,"city":50,"state":18,"zip":18,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Edith Wolfson Medical Center","Holon",{"type":41,"coordinates":52},[53,54],34.77918,32.01034,{"lat":54,"lon":53},[57],{"name":58,"role":30,"phone":59,"phoneExt":18,"email":60},"Liat Mor","+972546738294","liatmor1@gmail.com",{"facility":62,"status":18,"city":63,"state":18,"zip":18,"country":38,"countryCode":39,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Meir Medical Center","Kfar Saba",{"type":41,"coordinates":65},[66,67],34.90694,32.175,{"lat":67,"lon":66},[70],{"name":71,"role":30,"phone":72,"phoneExt":18,"email":73},"Sapir Nachshon","+972526525154","Sapir4790@gmail.com",{"facility":75,"status":18,"city":76,"state":18,"zip":18,"country":38,"countryCode":39,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Rabin Medical Center","Petah Tikva",{"type":41,"coordinates":78},[79,80],34.88747,32.08707,{"lat":80,"lon":79},[83],{"name":84,"role":30,"phone":85,"phoneExt":18,"email":18},"Bar Narkis","+972546335114",{"type":87,"investigatorFullName":29,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Principal Investigator, OB-GYN Resident",[90,92,95,96],{"name":91,"class":6},"Clalit Health Services",{"name":93,"class":94},"Wolfson Medical Center","OTHER_GOV",{"name":75,"class":6},{"name":62,"class":6},"100630761","use-of-nitrous-oxide-for-pain-and-anxiety-management-during-cervical-cerclage-removal-100630761",false,"NCT07491874","Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal","Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal- A Multicenter Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Women at ≥34 weeks of gestation\n* Singleton or twin pregnancy\n* Ability to understand, sign informed consent, and complete questionnaires\n\nExclusion Criteria:\n\n* Triplet or higher-order pregnancy\n* Contraindications to nitrous oxide use\n* Fetal monitoring category 2 or higher\n* Maternal body temperature \\>38°C\n* Significant vaginal bleeding\n* Severe preeclampsia\n* Cerclage removal under general anesthesia\n* Language or cognitive barrier\n* Baseline pain \\>3 on VAS scale, prior to the procedure","FEMALE","18 Years",{"count":107,"type":108},60,"ESTIMATED","INTERVENTIONAL",[111],"NA","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.\n\nThe study will include pregnant women aged 18 years or older undergoing elective cervical cerclage removal at 36 weeks of gestation or later.\n\nThe main questions the study aims to answer are:\n\n* Does inhaled nitrous oxide reduce pain during cervical cerclage removal?\n* Does inhaled nitrous oxide reduce anxiety during the procedure?\n* Does the use of nitrous oxide improve overall patient satisfaction during cerclage removal?\n\nResearchers 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.\n\nParticipants will:\n\n* Be randomly assigned to receive either inhaled nitrous oxide (50% nitrous oxide \u002F 50% oxygen) or standard care without analgesic treatment during cervical cerclage removal.\n* Undergo the procedure according to routine clinical practice in the participating centers.\n* Complete questionnaires assessing pain and anxiety, including a visual analog scale (VAS) for pain and the State-Trait Anxiety Inventory (STAI).\n* Have routine clinical data recorded from their medical records, including maternal vital signs and any procedure-related side effects.",[114,115,116],"Preterm Delivery","Cervical Cerclage","Cervical Insufficiency","NOT_YET_RECRUITING","2026-04-02",{"date":120,"type":121},"2026-04-08","ACTUAL",{"date":123,"type":108},"2026-05-01",{"date":125,"type":108},"2028-05-01",{"name":5,"class":6},4]