Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Use of IUD
研究概览
简要总结
The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.
详细描述
Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women 16 years of age and older
- •intrauterine pregnancy > 14 weeks gestation
- •desires termination of pregnancy
- •desires IUD for contraception
- •ability to give informed consent
- •no contraindication for D+E
排除标准
- •unable to give informed consent
- •less than 16 years of age
- •congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- •acute pelvic inflammatory disease (PID)
- •known or suspected uterine or cervical neoplasia or unresolved abnormal PAP smear
- •untreated acute cervicitis or vaginitis, until infection treated/controlled
- •confirmed Chlamydia trachomatis or Neisseria gonorrhea infection in the previous 90 days
- •acute liver disease or liver tumor (benign or malignant)
- •woman or partner currently with multiple sexual partners
- •history of Wilson's disease
- •hypersensitivity to any component of Copper T IUD
结局指标
主要结局
Use of IUD
时间窗: 6 months
Number of participants using Copper T380A IUD 6 months after surgery
次要结局
- Expulsion(6 months)
研究者
Miriam Cremer
Clinical Assistant Professor
NYU Langone Health