Abnormal Uterine Bleeding (AUB), Endometrial Pathology, Intrauterine Diseases, Postmenopausal Bleeding, Postmenopausal Women
Conditions
Keywords
Postmenopausal women, Postmenopausal bleeding, Office hysteroscopy, Cervical preparation, Vaginal estrogen, Oral misoprostol, Visual Analog Scale, Vaginoscopy, No touch approach
Brief 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.
Interventions
OTHERNo Cervical Preparation
No pharmacological cervical preparation is administered before office hysteroscopy.
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.
Sponsors
Faculty of Medicine of Tunis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful office hysteroscopy | During the office hysteroscopy procedure | A complete hysteroscopic examination of the uterine cavity. |
| Pain during office hysteroscopy | During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related complications | During the procedure and up to 24 hours after office hysteroscopy | 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 | Immediately after the procedure | 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 | From date of randomization up to 14 days | Incidence of adverse effects related to cervical preparation, including abdominal pain, uterine cramping, vaginal bleeding, nausea, vomiting, diarrhea, headache, dizziness, or local vaginal irritation. |
Countries
Tunisia
Contacts
CONTACTMohammed Amine Hannachi, Assistant professor
STUDY_CHAIRKHALED M NEJI
Maternity and neonatology center of Tunis
Outcome results
None listed