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临床试验/NCT02842177
NCT02842177已完成不适用

Classic vs. Uterine Sound-sparing Approach for Insertion of Copper T380A Intrauterine Device

Assiut University2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Successful intrauterine device insertion

研究概览

简要总结

The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.

The fear and the pain associated with intrauterine devices insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.

The pain during intrauterine devices insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the intrauterine devices through the cervix, and irritation of the endometrial lining by the intrauterine devices .

Previous studies have reported different lines to decrease pain during intrauterine device insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or intrauterine lidocaine and misoprostol up to paracervical blocks.

Previous studies, in literature, have found that the most painful steps during intrauterine devices insertion were uterine sounding then intrauterine device insertion itself, followed by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum and a single-tooth tenaculum on pain perception during intrauterine devices and found no difference in reported pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women requesting intrauterine contraceptive device as a contraction

排除标准

  • Uterine abnormalities
  • Endometrial lesions,
  • Adenomyosis
  • Intrauterine adhesions.
  • Chronic pelvic pain
  • Spasmodic dysmenorrhea
  • History of cervical surgery

结局指标

主要结局

Successful intrauterine device insertion

时间窗: 5 minutes

defined by a distance from the intrauterine device to the end of endometrial line of less than 25 mm The degree of total pain perception during intrauterine contraceptive insertion measured by visual analogue scale

次要结局

  • the duration of intrauterine device insertion(5 minutes)
  • The degree of pain during intrauterine device insertion(5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Dr

Assiut University

研究点 (2)

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