RecruitingNot ApplicableNCT07697781

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

Enrollment

120 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Misoprostol ( Cytotec) 200 microgram a tablet, No Cervical Preparation, and others for people with abnormal uterine bleeding (aub), endometrial pathology, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo Cervical Preparation

No pharmacological cervical preparation is administered before office hysteroscopy.

DRUGMisoprostol ( Cytotec) 200 microgram a tablet

Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.

DRUGVaginal Estrogen (7-Day Regimen)

Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.

DRUGVaginal 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

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NCT07697781


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