A Randomized Controlled Trial of Ultrasound-Guided Intrauterine Device (IUD) Insertion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Number of Participants Who Had IUD Removed Within 6 Months
研究概览
简要总结
To determine the utility of ultrasound guided IUD insertion compared to the traditional blind insertion at an academic health institute where the skill level of the provider can vary greatly. We hypothesize that ultrasound-guided insertion will lead lower IUD discontinuation rates and greater patient satisfaction.
详细描述
(Visit 1) All interested women undergoing a scheduled IUD insertion will be screened for inclusion/exclusion criteria by the study coordinator or investigator prior to their clinic visit.
(Visit 2) After meeting eligibility criteria and being consented for the study, a subject will be ready to be randomized. Subject in both groups will fill out a visual analogue score (VAS) before and after the procedure grading their pain. Subjects will be instructed to call the investigator if they experience any abnormal uterine bleeding or problems with their IUD.
Subjects will then be randomized to one of two groups:
Group A: traditional blind IUD insertion. Group B: transabdominal ultrasound guided IUD insertion. Subjects will be randomized to either US guided or traditional placement of IUD using 1:1 allocation. The randomization scheme for this study will use variable-size, random permuted blocks where the variable block sizes are 2,4 and 6.
(Visit 3) Subjects will be scheduled to return to REI clinic 4-6 weeks (Visit 2) after insertion of the IUD as routine follow-up. Subjects will be asked about any adverse events. A routine string check in the form of a speculum exam will be performed in addition to a transvaginal ultrasound to confirm positioning of the IUD. If malposition is determined, then routine care will be to remove the IUD. The ultrasound operator will be blinded to the subject's arm in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Undergoing IUD Insertion in an Office Setting
- •Fluent in Spoken and Written English
- •Premenopausal
排除标准
- •Less than 6 Weeks Postpartum at Time of IUD Insertion
- •Intraoperative IUD Insertion
- •Prisoners
- •Cognitive Impairment
- •Unable to Read or Write
结局指标
主要结局
Number of Participants Who Had IUD Removed Within 6 Months
时间窗: 6 Months
IUD discontinuation rates during the 6-month post-insertion period
次要结局
- Number of Participants With Malpositioned IUD at 4-6 Week Visit(4-6 Weeks Post Insertion String Check)
- Change in Pain Score(pre and post-insertion (both collected during the insertion visit))
- Number of Participants Satisfied With IUD at 6 Months(6 Months)
研究者
Stephanie Estes
Assistant Professor, Director, Robotic Surgical Services
Milton S. Hershey Medical Center