Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 主要终点
- Number of Participants Who Expelled IUDs by12 Weeks Postpartum
研究概览
简要总结
This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The investigators will compare the postplacental insertion expulsion rate estimate with rates reported in the literature for 6 week postpartum insertion, which is currently the American standard for IUD insertion postpartum. Secondary outcomes will also be examined; endometritis, uterine perforation, continuation and pregnancy among others.
详细描述
The average expulsion rate for 6 week postpartum IUD insertion is approximately 10-12% with a range between 3-20% at 1 year. An acceptable expulsion rate for postplacental insertion (PPI) has not been defined and varies between studies. There are limited data on the expulsion rates of levonorgestrel intrauterine systems. Expulsion rates range widely from 1-3% to as high as 30-40% depending on the IUD and the study. Studies report an average rate of expulsion in ranges approximating 10-12%, similar to 6 week insertion rates.
There are many limitations to published studies including the use of older model IUDs no longer in use, multiple insertion techniques that have been deemed ineffective in reducing expulsion rates as well as varying follow up times making comparison of expulsion rates difficult.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18 or greater
- •obstetric patient in greater Portland, ME area
排除标准
- •Evidence of chorioamnionitis (persistent fetal tachycardia, intra-partum fever >38.0)
- •prolonged rupture of membranes (greater than 24 hours)
- •intrauterine fetal demise
- •use of general anesthesia at time of delivery
- •postpartum hemorrhage (>500ml vaginal, >1000ml cesarean)
- •magnesium administration in labor due to HELLP syndrome or preeclampsia
- •preterm delivery.
研究组 & 干预措施
Mirena IUD Placement Immediately Post-delivery
Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks.
干预措施: Levonorgestrel Intrauterine Device (Device)
结局指标
主要结局
Number of Participants Who Expelled IUDs by12 Weeks Postpartum
时间窗: up to 12 weeks postpartum
Number of participants who expelled IUDs by12 weeks postpartum across all participants
次要结局
未报告次要终点
研究者
Rebecca Hunt
Physician, MMP Women's Health Maternal-Fetal Medicine
MaineHealth