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Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Sponsor: Faculty of Medicine of Tunis
Summary
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 success, procedure duration, bleeding, and perioperative complications.
Official title: A Four-Arm Prospective Randomized Controlled Trial Comparing Oral Misoprostol, Two Vaginal Estrogen Regimens, and No Cervical Preparation Before Office Hysteroscopy in Postmenopausal Women
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-01-02
Completion Date
2026-09-30
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
No Cervical Preparation
No pharmacological cervical preparation is administered before office hysteroscopy.
Misoprostol ( Cytotec) 200 microgram a tablet
Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.
Vaginal Estrogen (7-Day Regimen)
Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.
Vaginal Estrogen (14-Day Regimen)
Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.
Locations (1)
Maternity and neonatology center of Tunis
Tunis, Tunis Governorate, Tunisia