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临床试验/NCT03383432
NCT03383432已完成不适用

Ultrasound-guided Approach Versus Uterine Sound-sparing Approach for Intrauterine Device Insertion a Randomized Clinical Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019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
入组人数
88
试验地点
2
主要终点
Level of satisfaction of patients in both groups (satisfaction score)

研究概览

简要总结

The intrauterine device is a safe, reliable and long-acting reversible contraceptive method. Instrumentation of lower genital mucosa during intrauterine device application provokes pain because it is highly sensitive to touch. Fear of pain associated with intrauterine device insertion is considered a barrier to use this contraception method.

The classic insertion instructions recommend performing bimanual examination and uterine sounding prior to intrauterine device insertion in order to confirm proper determination of uterine size and position. The pain during intrauterine device insertion could be due to cervical grasping by the tenaculum, traction on the cervical canal, stretching of the internal os by the uterine sound or the intrauterine device inserter, and lastly by irritation of the endometrial lining by the intrauterine device.

Many studies investigated the use of various analgesics in different doses and routes of administration and found out that it has a significant impact on relieving of associated pain Some technical modifications have been emerged in trial to decrease pain during intrauterine device insertion. One of them is trans-abdominal ultrasound guided intrauterine device insertion which the participant with a full bladder is subjected to intrauterine device insertion under ultrasonographic guide without using tenaculum. This method effectively decreased the pain and time of intrauterine device insertion.

A recent method named "Uterine Sounding Sparing Approach" has been reported very recently in literature by Ali et al., 2017. In this method; the sonographer performs T transvaginal ultrasound to evaluate the uterine position and the endometrial length in the sagittal view of the uterus. The intrauterine device was inserted directly into the uterine cavity without using uterine sounding.

In spite of less pain reported by trans-abdominal ultrasound guided intrauterine device insertion (no vulsellum was used), this methods also have some drawbacks, firstly; the full bladder may displace the cervix upward making the intrauterine device application not quite easy and secondly; this method needs two investigators which may distress the women who wondering about this. These two drawbacks may decrease patient's and physician's satisfaction. The uterine sounding sparing approach lacks these two drawbacks which make it more satisfying.

From above evidence, there is a strong need to compare the satisfaction rate between the two mentioned approaches in trial to answer this question. Up to our knowledge; no randomized trial has been conducted or registered to compare the satisfaction rate between two above approaches.

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
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-49 years
  • Nonpregnant
  • Women did not receive any analgesics or misoprostol in the 24 hours prior to insertion.

排除标准

  • Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, fibroids
  • Allergy to Copper.

结局指标

主要结局

Level of satisfaction of patients in both groups (satisfaction score)

时间窗: 5 minutes after intrauterine device insertion

Measured by visual analogue like scale from 0 to 10

次要结局

  • Level of reported pain (visual analogue scale )(5 minutes after intrauterine device insertion)

研究者

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

Mohammed Khairy Ali

lecturer

Assiut University

研究点 (2)

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