Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

A Four-Arm Prospective Randomized Controlled Trial Comparing Oral Misoprostol, Two Vaginal Estrogen Regimens, and No Cervical Preparation Before Office Hysteroscopy in Postmenopausal Women

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Women with postmenopausal status.

• Scheduled for office hysteroscopy for the evaluation of suspected intrauterine pathology.

• Able to understand the study procedures and provide written informed consent.

Locations
Other Locations
Tunisia
Maternity and neonatology center of Tunis
RECRUITING
Tunis
Contact Information
Primary
Mohammed Amine Hannachi, Assistant professor
medaminehannachi3@gmail.com
+21699696332
Time Frame
Start Date: 2026-01-02
Estimated Completion Date: 2026-08-20
Participants
Target number of participants: 120
Treatments
Other: No Cervical Preparation
Participants undergo office hysteroscopy without any cervical preparation.
Experimental: Oral Misoprostol
Participants receive 200 µg of misoprostol administered sublingually 2 hours before office hysteroscopy.
Experimental: 7-Day Vaginal Estrogen
Participants receive 20 µg vaginal estrogen once daily for 7 consecutive days before office hysteroscopy.
Experimental: 14-Day Vaginal Estrogen
Participants receive 20 µg vaginal estrogen once daily for 14 consecutive days before office hysteroscopy.
Related Therapeutic Areas
Sponsors
Leads: Faculty of Medicine of Tunis

This content was sourced from clinicaltrials.gov