[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646011":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":59,"overallOfficials":76,"centralContacts":81,"locations":87,"responsibleParty":109,"collaborators":30,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":30,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":30,"maxAge":30,"enrollmentInfo":121,"targetDuration":30,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":89,"whyStopped":30,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Faculty of Medicine of Tunis","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Successful office hysteroscopy","A complete hysteroscopic examination of the uterine cavity.","During the office hysteroscopy procedure",{"measure":14,"description":15,"timeFrame":16},"Pain during office hysteroscopy","Patient-reported pain assessed using a 10-cm Visual Analog Scale (VAS) during hysteroscopy, 5 minutes after the procedure and 10 minutes after the procedure. 0 is assigned to no pain \\& 10 is assigned to the most pain imaginable.","During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.",[18,22,26],{"measure":19,"description":20,"timeFrame":21},"Procedure-related complications","Incidence of complications occurring during or immediately after office hysteroscopy, including cervical laceration, uterine perforation, excessive bleeding, vasovagal reaction, or failure requiring conversion to hysteroscopy under anesthesia.","During the procedure and up to 24 hours after office hysteroscopy",{"measure":23,"description":24,"timeFrame":25},"Patient satisfaction with cervical preparation","Patient satisfaction with the assigned cervical preparation protocol, assessed using a Patient Satisfaction Percentage Scale, a self-reported scale ranging from 0% to 100%, where 0% indicates not satisfied at all and 100% indicates completely satisfied. Higher scores indicate greater patient satisfaction.","Immediately after the procedure",{"measure":27,"description":28,"timeFrame":29},"Adverse effects of cervical preparation","Incidence of adverse effects related to cervical preparation, including abdominal pain, uterine cramping, vaginal bleeding, nausea, vomiting, diarrhea, headache, dizziness, or local vaginal irritation.","From date of randomization up to 14 days",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38,43,49,54],{"label":39,"type":6,"description":40,"interventionNames":41},"No Cervical Preparation","Participants undergo office hysteroscopy without any cervical preparation.",[42],"Other: No Cervical Preparation",{"label":44,"type":45,"description":46,"interventionNames":47},"Oral Misoprostol","EXPERIMENTAL","Participants receive 200 µg of misoprostol administered sublingually 2 hours before office hysteroscopy.",[48],"Drug: Misoprostol ( Cytotec) 200 microgram a tablet",{"label":50,"type":45,"description":51,"interventionNames":52},"7-Day Vaginal Estrogen","Participants receive 20 µg vaginal estrogen once daily for 7 consecutive days before office hysteroscopy.",[53],"Drug: Vaginal Estrogen (7-Day Regimen)",{"label":55,"type":45,"description":56,"interventionNames":57},"14-Day Vaginal Estrogen","Participants receive 20 µg vaginal estrogen once daily for 14 consecutive days before office hysteroscopy.",[58],"Drug: Vaginal Estrogen (14-Day Regimen)",[60,63,68,72],{"type":6,"name":39,"description":61,"armGroupLabels":62,"otherNames":30},"No pharmacological cervical preparation is administered before office hysteroscopy.",[39],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":30},"DRUG","Misoprostol ( Cytotec) 200 microgram a tablet","Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.",[44],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":30},"Vaginal Estrogen (7-Day Regimen)","Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.",[50],{"type":64,"name":73,"description":74,"armGroupLabels":75,"otherNames":30},"Vaginal Estrogen (14-Day Regimen)","Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.",[55],[77],{"name":78,"affiliation":79,"role":80},"KHALED M NEJI","Maternity and neonatology center of Tunis","STUDY_CHAIR",[82],{"name":83,"role":84,"phone":85,"phoneExt":30,"email":86},"Mohammed Amine Hannachi, Assistant professor","CONTACT","+21699696332","medaminehannachi3@gmail.com",[88],{"facility":79,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"RECRUITING","Tunis","Tunis Governorate","1007","Tunisia","TN",{"type":96,"coordinates":97},"Point",[98,99],10.16579,36.81897,{"lat":99,"lon":98},[102,105],{"name":103,"role":84,"phone":104,"phoneExt":30,"email":86},"Mohammed Amine Hannachi","99696332",{"name":106,"role":84,"phone":107,"phoneExt":30,"email":108},"Khaled Neji, Professor","+21651352742","DRKHALEDNEJI21@GMAIL.COM",{"type":110,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Mohammed Amine HANNACHI","Assistant Professor","100646011","office-hysteroscopy-in-postmenopausal-women-a-randomized-trial-of-cervical-preparation-strategies-100646011",false,"NCT07697781","Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies","A Four-Arm Prospective Randomized Controlled Trial Comparing Oral Misoprostol, Two Vaginal Estrogen Regimens, and No Cervical Preparation Before Office Hysteroscopy in Postmenopausal Women","Inclusion Criteria:\n\n* Women with postmenopausal status.\n* Scheduled for office hysteroscopy for the evaluation of suspected intrauterine pathology.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected hormone-dependent malignancy (e.g., breast or endometrial cancer).\n* Active genital tract infection.\n* Contraindication or known hypersensitivity to misoprostol or vaginal estrogen.\n* Refusal to undergo office hysteroscopy without anesthesia.\n* Active uterine bleeding preventing adequate hysteroscopic visualization on the day of the procedure.","FEMALE",{"count":122,"type":123},120,"ESTIMATED","INTERVENTIONAL",[126],"NA","The goal of this randomized controlled trial is to evaluate the effectiveness of different cervical preparation strategies before office hysteroscopy in postmenopausal women undergoing evaluation for intrauterine pathology.\n\nThe main questions to answer are:\n\nDoes cervical preparation improve the success rate of complete office hysteroscopy in postmenopausal women? Which cervical preparation strategy provides better patient tolerance, as assessed by pain intensity during the procedure?\n\nResearchers will compare four cervical preparation protocols (14-day vaginal estrogen, 7-day vaginal estrogen, oral misoprostol, and no cervical preparation) to determine their effects on procedural success, pain, procedure duration, and perioperative complications.\n\nParticipants will be randomly assigned to one of the four cervical preparation protocols. They will undergo office hysteroscopy using a vaginoscopic (\"no touch\") approach without anesthesia. Then, they will have pain assessed using a visual analog scale (VAS) during the procedure. Finally, these informations will be collected: procedural success, procedure duration, bleeding, and perioperative complications.",[129,130,131,132,133],"Postmenopausal Women","Intrauterine Diseases","Endometrial Pathology","Postmenopausal Bleeding","Abnormal Uterine Bleeding (AUB)",[135,136,137,138,139,140,141,142,143],"Postmenopausal women","Postmenopausal bleeding","Office hysteroscopy","Cervical preparation","Vaginal estrogen","Oral misoprostol","Visual Analog Scale","Vaginoscopy","No touch approach","2026-07-09",{"date":146,"type":147},"2026-07-13","ACTUAL",{"date":149,"type":147},"2026-01-02",{"date":151,"type":123},"2026-08-20",{"name":5,"class":6},1]