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临床试验/NCT00200226
NCT00200226已完成3 期

Oral Misoprostol Before Endometrial Biopsy

Memorial University of Newfoundland2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2003年2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
72
试验地点
2
主要终点
pain/discomfort of endometrial biopsy

研究概览

简要总结

An endometrial biopsy involves a thin tube being passed through the cervix (opening of the uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort with this procedure especially if the cervix is not dilated or opened. Previous research has suggested that taking a drug called misoprostol may help the cervix to start to dilate or open. This study will see if misoprostol will help open the cervix for an endometrial biopsy, to lessen the discomfort and make the biopsy easier to perform.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women 19 years and older
  • planned endometrial biopsy

排除标准

  • known hypersensitivity or allery to prostaglandins
  • seizure disorder
  • liver disease
  • known abnormal liver function tests
  • pregnancy

研究组 & 干预措施

1

Placebo Comparator

Vitamin B6

干预措施: vitamin B6 (Drug)

2

Active Comparator

misoprostol

干预措施: misoprostol (Drug)

结局指标

主要结局

pain/discomfort of endometrial biopsy

时间窗: during procedure

次要结局

  • ease of performing biopsy(during procedure)
  • success of obtaining biopsy(during procedure)
  • potential side effects(time study drug taken until procedure)

研究者

申办方类型
Other

研究点 (2)

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