Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies

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.

Conditions

• Postmenopausal Women
• Intrauterine Diseases
• Endometrial Pathology
• Postmenopausal Bleeding
• Abnormal Uterine Bleeding (AUB)

Interventions

DRUG

Vaginal Estrogen (7-Day Regimen)

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

DRUG

Vaginal Estrogen (14-Day Regimen)

Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.

OTHER

No Cervical Preparation

No pharmacological cervical preparation is administered before office hysteroscopy.

DRUG

Misoprostol ( Cytotec) 200 microgram a tablet

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

Sponsors & Collaborators

• Faculty of Medicine of Tunis

  lead OTHER

Principal Investigators

• KHALED M NEJI · Maternity and neonatology center of Tunis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-02

Primary Completion

2026-07-30

Completion

2026-08-20

Countries

• Tunisia

Study Locations