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临床试验/NCT05263544
NCT05263544已完成不适用

Evaluation of Uterine Anatomical Flexion Degree ( Uterocervical Angle) in Cases With and Without Intrauterine Device (IUD) Dislocation

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年6月30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
78
试验地点
1
主要终点
Determination of factors associated with intrauterine device dislocation.

研究概览

简要总结

Investigators want to find numerical determination of the degree of anatomical anterior or posterior flexion of the uterus (uterocervical angle) at the intersection of both lines using a protractor, provided that straight lines are drawn from the middle of the cervical canal and the middle of the endometrial canal in cases where the intrauterine device is found to have dislocated and and cases with no dislocation. Investigators will also measure uterus size, uterine width, cervical canal length, endometrial canal length, endometrial canal width and compare the results in both groups.

详细描述

IUD (intrauterine device) is one of the most preferred birth control methods in our country and in the world, and this usage rate is approximately 23% in the world. In our country, this rate is around 17%. The high chance of success, ease of use and long-term effectiveness can be counted among the reasons for preference.Currently used IUD is a 'T' shaped, has a 380 mm copper surface and its arms open at the widest part of the endometrium (TCu380A), thereby preventing it from slipping back. Undesirable effects include pelvic pain, dysmenorrhea, heavy menstrual bleeding, malposition/dislocation. Malposition/dislocation occurs in approximately 10% of patients. Malposition/dislocation of the IUD may be associated with excessive menstrual bleeding, or the IUD may be displaced without any symptoms. Malposition/dislocation can be classified as expulsion, burial, displacement, or perforation. Expulsion is defined as partial or complete protrusion of the cervical canal, and displacement is defined as rotation of the IUD or its displacement towards the lower segments. At the same time, IUD may be embedded in the myometrium to such an extent that it does not reach the serosa of the myometrium, while it may puncture the serosa and cause perforation may occur. TCu380A devices have a 6% risk of expulsion in the first 1 year. Displacement or slippage of the IUD reduces the effectiveness of the IUD and may cause expulsion. Therefore, being able to predict that the IUD will not slip is very important in terms of preventing unwanted pregnancies. In our study, in both groups with and without displaced IUD, uterus size, uterine width, cervical canal length, endometrial canal length, endometrial canal width, and the angle at the intersection of the imaginary lines corresponding to the middle of the endometrium and cervical canal, which can be detected by transvaginal ultrasound were measured. Investigators aimed to determine the measurements and compare the obtained data to find associated factors related to dislocation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • using intrauterine device

排除标准

  • Pelvic mass that cannot be differentially diagnosed by physical examination and imaging techniques
  • Having an indication for surgical treatment
  • Presence of space-occupying polyp or fibroid affecting the anatomy of the endometrium
  • Presence of myoma or adenomyosis that disrupts the integrity of the myometrium
  • Presence of pelvic infection
  • Currently using any hormonal therapy
  • History and/or presence of malignancy
  • Pregnancy
  • Menopause or premature ovarian failure

结局指标

主要结局

Determination of factors associated with intrauterine device dislocation.

时间窗: 6 months

endometrial canal width (mm) will be measured and assessed for association with dislocation.

次要结局

未报告次要终点

研究者

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

Fatma Ketenci Gencer, MD

Principal investigator

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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