Intrauterine Contraception for Adolescents Aged 14 to 18: A Multi-center Randomized Controlled Feasibility Trial of Levonorgestrel-releasing Intrauterine System Compared to the Copper T 380A
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Retention Rate
研究概览
简要总结
This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Copper T 380A.
详细描述
Teenagers have the highest percentage of unintended pregnancies, and often struggle to comply with daily methods of contraception. The intrauterine device (IUD) provides safe, long-term protection and rates highly for patient satisfaction. It also does not require repeat prescriptions or clinic visits, making it a potentially attractive method among teens. However, in adolescent populations, there is both a lack of information about the IUD, as well as few studies that have examined the use of these devices. This study will examine whether a larger scale study on this topic is feasible. IT will address the feasibility of recruiting, consenting, screening, enrolling, randomizing, and retaining adolescents randomized to the LNG-IUS or Copper T 380a.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, sexually active females age 14 to 18 who:
- •Are interested in long term, reversible contraception
- •Have regular menstrual cycles (21-35 days)
- •Are not planning a pregnancy within the next 6 months
排除标准
- •Sexually active females age over the age of 18 or who:
- •Are not interested in long term, reversible contraception
- •Do not have regular menstrual cycles (21-35 days)
- •Are planning a pregnancy within the next 6 months
研究组 & 干预措施
Mirena IUD [LNG-IUS]
Participants in this arm had a Levonorgestrel-releasing intrauterine device (LNG-IUS), also known as the Mirena IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.
干预措施: Levonorgestrel-releasing intrauterine device (LNG-IUS) (Device)
Paragard IUD [Copper T380A]
Participants in this arm had a Copper T380A intrauterine device (CuT380A), also known as the Paragard IUD, inserted within the first 5 days of the adolescent's menstrual cycle, at least 7 weeks after a vaginal or cesarean delivery or second-trimester abortion or at least 3 weeks after a first-trimester abortion. For participants who had used depot-medroxyprogesterone acetate, insertions occurred at least 6 months after the participant's last injection. Participants were blinded to the device type; however, investigators and research assistants were not.
干预措施: Copper T380A intrauterine device (CuT380A) (Device)
结局指标
主要结局
Retention Rate
时间窗: 6 months
Percentage of participants who completed the final visit (i.e., not subject to early termination or loss to follow-up)
次要结局
- Heavy Bleeding Rates(6 months)
- Pregnancy Rates(6 months)
- Expulsion Rates(6 months)
- Device Satisfaction Rates(6 months)