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临床试验/NCT02020733
NCT02020733已完成不适用

Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula

Sadiman Kiykac Altinbas2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
194
试验地点
2
主要终点
the degree of pain experienced during the procedure

研究概览

简要总结

The aim of this study is to compare the metal cannula routinely used in our clinical practice with intrauterine hysterosalpingography catheter as a probable alternative device in a prospective, single-blinded, randomized study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 47 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged between 18-47 years,
  • applying for basic infertility evaluation to the Reproductive Endocrinology unit

排除标准

  • The patients with a known hypersensitivity to iodine or radio-opaque contrast dye,
  • vaginal bleeding,
  • genital malignancy and
  • any sign of pelvic inflammatory disease (PID) were excluded

结局指标

主要结局

the degree of pain experienced during the procedure

时间窗: 1 hour after the procedure

The primary outcome was the degree of pain experienced during the procedure, pain was evaluated with the Wong Baker Faces Pain Rating Scale (WBS), which ranked the pain from 0 to 5.

次要结局

未报告次要终点

研究者

发起方
Sadiman Kiykac Altinbas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sadiman Kiykac Altinbas

M. D.

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

研究点 (2)

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