No phaseRecruitingAge-related condition
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
- Sponsor
- Faculty of Medicine of Tunis (Academic or other)
- Enrolment
- 120 planned
- Conditions
- Postmenopausal Women; Intrauterine Diseases; Endometrial Pathology; Postmenopausal Bleeding; Abnormal Uterine Bleeding (AUB)
- Interventions
- No Cervical Preparation; Misoprostol ( Cytotec) 200 microgram a tablet; Vaginal Estrogen (7-Day Regimen); Vaginal Estrogen (14-Day Regimen)
- Ages
- children, adults, older adults
- Registry
- NCT07697781
Full record on ClinicalTrials.gov
From the registry
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. The main questions to answer are: Does 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? Researchers 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. Participants 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…
Primary outcomes
- Successful office hysteroscopy
- Pain during office hysteroscopy
History
Study completion expected
Last registry update
Primary completion
Registered
Started