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临床试验/NCT06554249
NCT06554249尚未招募不适用

Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance Versus the Standard Technique for IUD Insertion

Cairo University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
82
试验地点
1
主要终点
Intensity of pain

研究概览

简要总结

The aim of this study is to determine whether full bladder IUD insertion without vulsellum or uterine sound under ultrasound guidance is associated with less pain compared with the standard technique of IUD insertion .

详细描述

The intrauterine device (IUD) is an effective method of contraception. Pain experienced during IUD insertion is one of the main causes that limits its widespread use.

Pain during IUD insertion is caused by insertion of cusco vaginal speculum, sounding the uterus, application of vulsellum to grasp the cervix, the passage of the inserter tube through the cervical canal and uterine cavity..

In order to minimize the pain associated with IUD insertion , several studies reported that the use of ultrasound to guide the insertion of IUD into uterine cavity was associated with less pain and more accurate placement of IUD, other studies reported that filling the bladder during IUD insertion minimized the pain associated with IUD insertion.

研究设计

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

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women requesting IUD insertion

排除标准

  • Active pelvic infection
  • Viable intrauterine pregnancy
  • Uterine anomalies
  • Uterine fibroid
  • Wilson disease

结局指标

主要结局

Intensity of pain

时间窗: Immediately after the procedure

Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain)

次要结局

  • Success of IUD insertion(Immediately after the procedure)

研究者

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

Usama M Fouda

Prof.

Cairo University

研究点 (1)

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