Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
2026年9月7日 更新者：Mohammed Amine HANNACHI、Faculty of Medicine of Tunis
A Four-Arm Prospective Randomized Controlled Trial Comparing Oral Misoprostol, Two Vaginal Estrogen Regimens, and No Cervical Preparation Before Office Hysteroscopy in Postmenopausal Women
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.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mohammed Amine Hannachi, Assistant professor
- 电话号码：+21699696332
- 邮箱：medaminehannachi3@gmail.com
学习地点
-
-
Tunis Governorate
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Tunis、Tunis Governorate、突尼斯、1007
- 招聘中
- Maternity and neonatology center of Tunis
-
接触：
- Khaled Neji, Professor
- 电话号码：+21651352742
- 邮箱：DRKHALEDNEJI21@GMAIL.COM
-
接触：
- Mohammed Amine Hannachi
- 电话号码：99696332
- 邮箱：medaminehannachi3@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：No Cervical Preparation
Participants undergo office hysteroscopy without any cervical preparation.
|
No pharmacological cervical preparation is administered before office hysteroscopy.
|
|
实验性的：Oral Misoprostol
Participants receive 200 µg of misoprostol administered sublingually 2 hours before office hysteroscopy.
|
Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.
|
|
实验性的：7-Day Vaginal Estrogen
Participants receive 20 µg vaginal estrogen once daily for 7 consecutive days before office hysteroscopy.
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Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.
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实验性的：14-Day Vaginal Estrogen
Participants receive 20 µg vaginal estrogen once daily for 14 consecutive days before office hysteroscopy.
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Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Successful office hysteroscopy
大体时间：During the office hysteroscopy procedure
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A complete hysteroscopic examination of the uterine cavity.
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During the office hysteroscopy procedure
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Pain during office hysteroscopy
大体时间：During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.
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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.
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During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Procedure-related complications
大体时间：During the procedure and up to 24 hours after office hysteroscopy
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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.
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During the procedure and up to 24 hours after office hysteroscopy
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Patient satisfaction with cervical preparation
大体时间：Immediately after the procedure
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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.
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Immediately after the procedure
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Adverse effects of cervical preparation
大体时间：From date of randomization up to 14 days
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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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From date of randomization up to 14 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：KHALED M NEJI、Maternity and neonatology center of Tunis
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月2日
初级完成 (实际的)
2026年7月30日
研究完成 (估计的)
2026年9月30日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月9日
首次发布 (实际的)
2026年7月13日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CERV-PREP-MENO-HSC
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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