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

Faculty of Medicine of Tunis120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Postmenopausal Women Intrauterine Diseases

Interventions

No Cervical PreparationOTHER

No pharmacological cervical preparation is administered before office hysteroscopy.

Misoprostol ( Cytotec) 200 microgram a tabletDRUG

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

Vaginal Estrogen (7-Day Regimen)DRUG

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

Vaginal Estrogen (14-Day Regimen)DRUG

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Known or suspected hormone-dependent malignancy (e.g., breast or endometrial cancer). * Active genital tract infection. * Contraindication or known hypersensitivity to misoprostol or vaginal estrogen. * Refusal to undergo office hysteroscopy without anesthesia. * Active uterine bleeding preventing adequate hysteroscopic visualization on the day of the procedure.

Outcomes

Primary Outcomes

Successful office hysteroscopy

A complete hysteroscopic examination of the uterine cavity.

Time frame: During the office hysteroscopy procedure

Pain during office hysteroscopy

Patient-reported pain assessed using a 10-cm Visual Analog Scale (VAS) during hysteroscopy, 5 minutes after the procedure and 10 minutes after the procedure. 0 is assigned to no pain \& 10 is assigned to the most pain imaginable.

Time frame: During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.

Secondary Outcomes

Procedure-related complications

Incidence of complications occurring during or immediately after office hysteroscopy, including cervical laceration, uterine perforation, excessive bleeding, vasovagal reaction, or failure requiring conversion to hysteroscopy under anesthesia.

Time frame: During the procedure and up to 24 hours after office hysteroscopy

Patient satisfaction with cervical preparation

Patient satisfaction with the assigned cervical preparation protocol, assessed using a Patient Satisfaction Percentage Scale, a self-reported scale ranging from 0% to 100%, where 0% indicates not satisfied at all and 100% indicates completely satisfied. Higher scores indicate greater patient satisfaction.

Time frame: Immediately after the procedure

Adverse effects of cervical preparation

Incidence of adverse effects related to cervical preparation, including abdominal pain, uterine cramping, vaginal bleeding, nausea, vomiting, diarrhea, headache, dizziness, or local vaginal irritation.

Time frame: From date of randomization up to 14 days