GYNEFIX-VIZ*: A STUDY OF SEROSAL-ANCHOR (SA) DISTANCE IN WOMEN IMMEDIATELY AND 6-8 WEEKS FOLLOWING INSERTION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,030
- 试验地点
- 2
- 主要终点
- Serosal-anchor Measurement
研究概览
简要总结
The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women requesting intrauterine contraception
- •willing to have a GyneFix IUD for pregnancy prevention
- •able to return for a follow-up ultrasound
- •able to read and understand consent form
排除标准
- •Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.)
- •Immediately after a pregnancy interruption > 10 weeks gestation
结局指标
主要结局
Serosal-anchor Measurement
时间窗: 6-8 weeks
endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus
次要结局
- Complications(5 years)