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临床试验/NCT01024270
NCT01024270已完成3 期

Cervical Priming With Misoprostol Prior to Operative Hysteroscopy

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
141
试验地点
1
主要终点
The primary outcome measure in this study was the preoperative cervical width after misoprostol administration.

研究概览

简要总结

The primary outcome measure in this study was the preoperative cervical width after misoprostol administration. The secondary outcomes were duration of cervical dilatation, up to Hegar number 10, complications during cervical dilation and the hysteroscopy, and misoprostol associated side effects. The cervical width was assessed by performing cervical dilatation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilatators until the dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width.

The mean cervical diameter, after oral and vaginal misoprostol of 400 μg, has been reported to be 6.0 ± 1.5 mm and 7.3 ± 1.6 mm, respectively 4. The investigators hypothesized that equivalence was of clinical significance if the difference in the initial cervical width was less than 1 mm among groups with the standard deviation of the initial cervical width of 1.6 mm. The estimated sample size was 47 patients in each group; this would be able to detect an equivalent effect in the groups with a power of 80% and a type 1 error (a) of 0.017. Data are expressed as the mean ± SD (standard deviation) or median with range or as the number (%) of cases.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Single (Care Provider)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Symptomatic patients that were suspected as having intrauterine pathology such as submucosal myoma, endometrial polyps or other endometrial pathological findings based on the transvaginal ultrasound were enrolled.
  • women who are more than 20 years of age with having sexual contact history
  • women whose last menstrual period are within the last two months.

排除标准

  • Post menopausal women
  • any evidence of a contraindication or allergy to PGs
  • any sign of genital infection, history of cervical surgery, endometrial lesions with suspected endo- or exocervical lesions that could affect the cervical resistance or patients that were not candidates for surgery.

研究组 & 干预措施

sublingual, oral and vaginal administration of misoprostol

Experimental

干预措施: Misoprostol (Drug)

结局指标

主要结局

The primary outcome measure in this study was the preoperative cervical width after misoprostol administration.

时间窗: 1 year

次要结局

  • Duration of cervical dilatation, up to Hegar number 10.(1 year)
  • Complications during cervical dilation.(1 year)
  • Misoprostol associated side effects.(1 year)
  • Complications during the hysteroscopy.(1)

研究者

申办方类型
Other

研究点 (1)

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