A Randomized Trial Evaluating the Effectiveness of a Previously Developed Online IUD Self-removal Guide Versus Basic Information Sheet in Clinical and Non-clinical Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Comparison of successful IUD self-removal rates
研究概览
简要总结
Investigators previously developed a guide to help people with IUD self-removal. In this randomized study, the goal is to see if this guide makes it easier for IUD-users to remove their own IUDs.
The main question the study aims to answer is:
-Does use of the previously developed IUD self-removal guide increase rates of self removal?
Participants will:
- Complete a pre-study survey
- Be randomized to self-removal with use of the guide or no additional resource
- Self-select participation at home or in clinic
- Attempt IUD self-removal either at home or in clinic
- Complete a post-study survey.
Investigators will compare rates of successful self-removal between those randomized to the guide to those randomized to no additional resource to see if increases success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 14 and older
- •IUD in place and desiring removal
- •Interest in attempting self-removal
- •English speaking
- •Working cell-phone with camera.
排除标准
- •Not meeting above inclusion criteria, no other specific exclusion criteria
研究组 & 干预措施
No guide
Randomized to use of no additional resource
Guide
Randomized to use of our IUD self-removal guide
干预措施: IUD self-removal guide (Other)
结局指标
主要结局
Comparison of successful IUD self-removal rates
时间窗: The post study survey will be completed within 48 hours of study participation. Participants schedule their participation on average 1-3 months from study enrollment but up to 1 year (the duration of the study being open).
Successful self-removal will be reported by participants on the post-study survey and documented with an uploaded photo of the removed IUD on a study ruler sheet. Rates of successful self-removal will be compared between those randomized to the guide versus no additional resource.
次要结局
未报告次要终点
研究者
Kelsey Petrie
Clinical Instructor
University of Washington