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.
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.
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.
Parallel
No Cervical Preparation
Other interventionNo pharmacological cervical preparation is administered before office hysteroscopy.
Misoprostol ( Cytotec) 200 microgram a tablet
DrugMisoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.
Vaginal Estrogen (7-Day Regimen)
DrugVaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.
Vaginal Estrogen (14-Day Regimen)
DrugVaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.
Successful office hysteroscopy
A complete hysteroscopic examination of the uterine cavity.
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.
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.
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.
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.
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