Insertion of an IUD After Medical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
研究概览
简要总结
The purpose of this study is to determine the expulsion and continuation rate of an intruterine device (IUD) placed immediately after medical abortion.
Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy).
详细描述
Women who seek abortion care often desire more effective or longer- lasting contraception. Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the US. We are interested in determining whether placement of an intreatuereine device (IUD) at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as IUDs placed after pregnancy (usually a 4-6 week time period). If this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. FDA labeling does not specify or restrict time of insertion and therefore this study is in compliance with FDA labeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who completed a medical abortion in the last 14 days
- •At least 18 years old.
- •Desiring long-term contraception with an IUD.
- •Able and willing to give consent for participation in research.
- •Gonorrhea and chlamydia screen negative within 60 days of entry to study.
- •Willing to comply with the study requirements.
- •Accessible by telephone.
排除标准
- •Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days.
- •Allergy to copper, or Wilson's disease (for Paragard; may have Mirena)
- •Intracavitary of symptomatic uterine fibroids.
- •Ovarian, cervical or endometrial cancer.
- •Severe anemia (defined as hgb < 8).
结局指标
主要结局
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
时间窗: Three months
次要结局
- Percentage of Women Continuing IUD Use at 3 Months(3 months)