Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Breastfeeding
研究概览
简要总结
This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Immediate
Placement within 48 hours of delivery
干预措施: Levonorgestrel-releasing intrauterine system (Drug)
Control
Placement 4-8 weeks after delivery
干预措施: Levonorgestrel-releasing intrauterine system (Drug)
结局指标
主要结局
Breastfeeding
时间窗: 6 months
Reported any breastfeeding at the final 6 month visit
次要结局
- LNG-IUS Expulsion or Removal(up to 6 months)