Estriol and Hyaluronic Acid in Cervical Preparation for Mini-hysteroscopy in Peri- and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The need of cervical dilation
研究概览
简要总结
Pain accompanying office hysteroscopy is the most common reason for its discontinuation. Urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. The aim was to evaluate the effectiveness of vaginal estradiol and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.
详细描述
A prospective cohort tertiary-center study includes women over 45 years of age subjected to office hysteroscopy in 2021-2022. Women who consent are assigned to three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). The following endpoints are compared: need for cervical dilation, incidence of severe urogenital atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain during and after the procedure in the Numeric Rating Scale (NRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 45-90 years
- •uterine cavity focal lesion, abnormal uterine bleeding
排除标准
- •drug allergy
- •no consent to the procedure or participation in the study
研究组 & 干预措施
1 (estradiol)
estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
干预措施: estradiol (Drug)
2 (hyaluronic acid)
hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
The need of cervical dilation
时间窗: up to 6 months
The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity
Intensification of pain during and after the procedure
时间窗: up to 6 months
Intensity of pain in Numeric Rating Scale (NRS: 0-10)
次要结局
- Cervical passage time(up to 6 months)
- Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)(up to 6 months)
- Occurrence of a vasovagal reaction(up to 6 months)
研究者
Iwona Magdalena Gawron
Ph.D., Principal Investigator
Jagiellonian University