[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615085":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Bnai Zion Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EMLA","EXPERIMENTAL",null,[13],"Drug: Topical Analgesia with Lidocaine-Prilocaine cream",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Topical Analgesia with Lidocaine-Prilocaine cream","patients allocated to \\'EMLA\\' arm will receive topical analgesia cream prior to speculum insertion, as part of the administration of balloon catheter insertion process.\n\n3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made to allow for maximal analgesic affect.",[9],{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"OTHER","patients allocated to \\'Placebo\\' arm will receive lubrication with placebo cream prior to speculum insertion, as part of the administration of balloon catheter insertion process.\n\n3 puffs of the cream will be applied to the perineum, posterior fourchette and posterior vaginal wall by administrating physician. A pause of 7 minutes in the process will be made.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Dafna Ben Yehuda Raz, MD, resident doctor","CONTACT","+97248359366","dafna.ben-yehuda@b-zion.org.il",{"name":36,"role":32,"phone":33,"phoneExt":11,"email":37},"Inna Bleicher, MD, MFM specialist","inna.bleicher@b-zion.org.il",[39],{"facility":5,"status":40,"city":41,"state":11,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Haifa","3339419","Israel","IL",{"type":46,"coordinates":47},"Point",[48,49],34.99928,32.81303,{"lat":49,"lon":48},[52,54],{"name":53,"role":32,"phone":33,"phoneExt":11,"email":34},"Dafna Ben Yehuda Raz, MD",{"name":55,"role":56,"phone":11,"phoneExt":11,"email":11},"Dafna Ben Yehuda Raz, MD, OBGYN resident","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100615085","phase-4-topical-anesthesia-during-catheter-insertion-for-cervical-ripening-tolerance-100615085",false,"NCT07288021","Topical Anesthesia During Catheter Insertion for Cervical Ripening (TOLERANCE)","TOLERANCE","Inclusion Criteria:\n\n* Women scheduled for labor induction with balloon catheter.\n* 18 years of age or older.\n* Singleton pregnancy with a cephalic presentation.\n* ≥ 34 completed gestational weeks.\n* Does not participate in any other trial that might affect maternal or fetal\u002Fneonatal outcomes.\n* No contraindication for vaginal delivery\n\nExclusion Criteria:\n\n* Unable or unwilling to provide and sign informed consent forms.\n* Known sensitivity to EMLA or placebo substance.\n* Known vulvodynia or vaginismus - rendering vaginal examination not possible.\n* Any chronic pain syndrome","FEMALE","18 Years",{"count":69,"type":70},200,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","The goal of this RCT is to learn if application of topical anesthetic cream to the perineum and posterior wall of vagina prior to balloon catheter insertion as part of labor induction will reduce pain levels experienced by pregnant individuals.\n\nAll participants are 18 or older, carrying a singleton in vertex position and in need of labor induction, are late-preterm or term (34 weeks gestation and onward) and without contraindication to vaginal delivery.\n\nInvestigators seek to compare pain levels and patient satisfaction between two groups:\n\nNulliparous patients, using EMLA or placebo (randomized, double blinded). Multiparous patients, EMLA or placebo.",[76],"Labor, Induced",[78,79,9,80,81],"induction","balloon catheter","Lidocaine\u002Fprilocaine","pain","2025-12-15",{"date":84,"type":85},"2025-12-17","ACTUAL",{"date":87,"type":85},"2024-02-05",{"date":89,"type":70},"2026-07-01",{"name":5,"class":6},1]