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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Cervical Preparation | Other | Participants undergo office hysteroscopy without any cervical preparation. |
|
| Oral Misoprostol | Experimental | Participants receive 200 µg of misoprostol administered sublingually 2 hours before office hysteroscopy. |
|
| 7-Day Vaginal Estrogen | Experimental | Participants receive 20 µg vaginal estrogen once daily for 7 consecutive days before office hysteroscopy. |
|
| 14-Day Vaginal Estrogen | Experimental | Participants receive 20 µg vaginal estrogen once daily for 14 consecutive days before office hysteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Cervical Preparation | Other | No pharmacological cervical preparation is administered before office hysteroscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful office hysteroscopy | A complete hysteroscopic examination of the uterine cavity. | 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. | During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the procedure and up to 24 hours after office hysteroscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Amine Hannachi, Assistant professor | Contact | +21699696332 | medaminehannachi3@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| KHALED M NEJI | Maternity and neonatology center of Tunis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity and neonatology center of Tunis | Recruiting | Tunis | Tunis Governorate | 1007 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32299254 | Background | Samy A, Nabil H, Abdelhakim AM, Mahy ME, Abdel-Latif AA, Metwally AA. Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study. Climacteric. 2020 Aug;23(4):397-403. doi: 10.1080/13697137.2020.1742685. Epub 2020 Apr 17. | |
| 30193870 | Background | Sauvan M, Pourcelot AG, Fournet S, Fernandez H, Capmas P. Office hysteroscopy for postmenopausal women: Feasibility and correlation with transvaginal ultrasound. J Gynecol Obstet Hum Reprod. 2018 Dec;47(10):505-510. doi: 10.1016/j.jogoh.2018.08.018. Epub 2018 Sep 5. |
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| Misoprostol ( Cytotec) 200 microgram a tablet | Drug | 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. |
|
| 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. | 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. | From date of randomization up to 14 days |
| 30468239 | Background | Wood MA, Kerrigan KL, Burns MK, Glenn TL, Ludwin A, Christianson MS, Bhagavath B, Lindheim SR. Overcoming the Challenging Cervix: Identification and Techniques to Access the Uterine Cavity. Obstet Gynecol Surv. 2018 Nov;73(11):641-649. doi: 10.1097/OGX.0000000000000614. |
| 33356672 | Background | Sorbi F, Fambrini M, Saso S, Lucenteforte E, Lisi F, Piciocchi L, Cioni R, Petraglia F. Office hysteroscopy in pre- and post-menopausal women: a predictive model. Gynecol Endocrinol. 2021 Mar;37(3):206-210. doi: 10.1080/09513590.2020.1864316. Epub 2020 Dec 26. |
| 10929961 | Background | Giorda G, Scarabelli C, Franceschi S, Campagnutta E. Feasibility and pain control in outpatient hysteroscopy in postmenopausal women: a randomized trial. Acta Obstet Gynecol Scand. 2000 Jul;79(7):593-7. |
| 10902812 | Background | Gorodeski GI. Effects of menopause and estrogen on cervical epithelial permeability. J Clin Endocrinol Metab. 2000 Jul;85(7):2584-95. doi: 10.1210/jcem.85.7.6671. |
| 21797959 | Background | Cooper NA, Smith P, Khan KS, Clark TJ. Does cervical preparation before outpatient hysteroscopy reduce women's pain experience? A systematic review. BJOG. 2011 Oct;118(11):1292-301. doi: 10.1111/j.1471-0528.2011.03046.x. Epub 2011 Jul 29. |
| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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