A Post Market Surveillance Study of the Performance and Safety of UT 380® Contraceptive Intra Uterine Device in Nulliparous, Uniparous and Multiparous Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Unintended pregnancy rate
研究概览
简要总结
The study is a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method.
详细描述
Prospective data on contraceptive performance of the UT380® from a large number of women are not yet available. Here we describe a long term Post Market Surveillance Study involving women who will received UT 380® device as a contraceptive method. Reports of case series usually contain detailed information about the individual patients. This includes demographic information (e.g. age and gender) and information on diagnosis, treatment, response to treatment, follow-up after treatment and patients experience of the treatment. In addition, it also include the health care staff's experience of the use of the UT 380. The result of this study will be used for different purposes e.g. marketing activities such as posters, folders, or targeted journals and/or conferences.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman > 18 years old
- •nulliparous, uniparous and multiparous
- •not currently using a contraceptive method or are willing to switch to a new reversible contraceptive
- •with an indication of implantation of a UT380® IUD
- •agreeing to participate in the study
排除标准
- •Patient with risk of post implantation bleeding or high level of bleeding during menstruation period
- •Patient with a risk of infection
- •Patient that meet any of the absolute contraindication of UT 380®
- •Any other elements that the investigator may think relevant and cannot allow the use of UT380®
结局指标
主要结局
Unintended pregnancy rate
时间窗: 5 years
Unintended pregnancy rate
Device expulsion rate
时间窗: 5 years
Device expulsion rate
Discontinuation rate
时间窗: 5 years
Discontinuation rate
次要结局
- Removal rate of the UT380® due to excessive bleeding(5 years)
- Extra uterine pregnancy rate(5 years)
- Removal rate of the UT380® due to pelvic inflammatory diseases(5 years)
- Assessment of physicians satisfaction regarding the use of the UT380 using 5 points likert scale (1: not at all satisfied 5: very satisfied)(5 years)
- Removal rate of the UT380® due to other disease relevant in the contexte of the trial(5 years)
- Safety data such as any issue occurring immediately after the implantation of the device(5 years)
- Safety data such as any issue during the device removal (such as pain, breaking device, excessive pulling force…)(5 years)
- Removal rate of the UT380® due to desired pregnancy(5 years)
- Removal rate of the UT380® due to any other personal reason(5 years)
- Assessment of patients satisfaction regarding the use of the UT 380® using 5 points likert scale (1: not at all satisfied 5: very satisfied)(5 years)
- Removal rate of the UT380® due to pain(5 years)
- Removal rate of the UT380® due to investigator decision(5 years)
- Safety data such as uterin perforation(5 years)
- Safety data such as any issue occurring between two visits: Abdominopelvic or uterine pain outside the menstrual cycle, bleeding,(5 years)