A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Expulsion Rate
研究概览
简要总结
The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •requesting non-hormonal intrauterine contraception
- •able to return for ultrasound in 6-8 weeks
排除标准
- •History of recent pelvic inflammatory disease
- •Known anemia
- •Dysfunctional uterine bleeding
- •Malignancy or suspected malignant disease of female inner or outer genitalia
- •Known intolerance or allergy to copper and/or copper IUDs
- •Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
- •Pregnancy
研究组 & 干预措施
IUB
There is one arm of women who will have IUBs inserted
干预措施: IUB (Device)
结局指标
主要结局
Expulsion Rate
时间窗: at 6-8 weeks
The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus
次要结局
- Acceptability(12 months)
- Complication(12 months)