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

Официальное название

A Four-Arm Prospective Randomized Controlled Trial Comparing Oral Misoprostol, Two Vaginal Estrogen Regimens, and No Cervical Preparation Before Office Hysteroscopy in Postmenopausal Women

Обзор

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.

Вмешательства

• Другое No Cervical Preparation
  No pharmacological cervical preparation is administered before office hysteroscopy.
• Препарат Misoprostol ( Cytotec) 200 microgram a tablet
  Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.
• Препарат Vaginal Estrogen (7-Day Regimen)
  Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.
• Препарат Vaginal Estrogen (14-Day Regimen)
  Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.

Первичные конечные точки

• Successful office hysteroscopy [Срок оценки: During the office hysteroscopy procedure]
• Pain during office hysteroscopy [Срок оценки: During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.]

Вторичные конечные точки (3)

• Procedure-related complications [Срок оценки: During the procedure and up to 24 hours after office hysteroscopy]
• Patient satisfaction with cervical preparation [Срок оценки: Immediately after the procedure]
• Adverse effects of cervical preparation [Срок оценки: From date of randomization up to 14 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Tunisia · 1 центр

• Maternity and neonatology center of Tunis — Tunis

Публикации

• 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. PMID 32299254
• 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. PMID 30193870
• 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. PMID 30468239
• 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. PMID 33356672
• 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. PMID 10929961
• 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. PMID 10902812
• 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. PMID 21797959

Идентификаторы

NCT: NCT07697781 · CERV-PREP-MENO-HSC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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