跳至主要内容
临床试验/NCT04782583
NCT04782583已完成不适用

Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 740 人开始时间: 2020年3月18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
740
试验地点
1
主要终点
Evaluating the risk of IUD displacement in patients using menstrual cup

研究概览

简要总结

In France, 26% of women of childbearing age use an intrauterine device (IUD) containing copper or levonorgestrel as a method of contraception. Failures of IUD contraception are mainly due to shifting or expulsion of the IUD. The risk factors for expulsion of IUDs most often found in the literature are young age (<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper IUD rather than a levonorgestrel IUD , a history of IUD expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis).

More and more women are turning to menstrual cups (MCs) as a means of periodic protection. But the use of MC has also been mentioned as a risk factor for IUD expulsion (via a suction effect). In May 2013, reports of displacement, rupture, or even expulsion of copper IUDs in CM users were reported to ANSM.

However, few studies have examined the risks associated with the concomitant use of an MC and an IUD. The data are contradictory and insufficient to provide a clear answer to women. Hence the interest in carrying out a larger prospective study to explore the relationship between IUD expulsion and the use of MC.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18 or over
  • Consultant for one of the following reasons:
  • IUD control
  • IUD expulsion
  • Pregnancy on IUD
  • Other reason that required an ultrasound for the IUD
  • Consent to participate in the study

排除标准

  • Patient benefiting from a legal protection measure

结局指标

主要结局

Evaluating the risk of IUD displacement in patients using menstrual cup

时间窗: 1 DAY

Transvaginal ultrasounds will be used to monitor the position of the intrauterine device in patients using a menstrual cup.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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