Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Use of the LNG-IUS for Contraception
研究概览
简要总结
The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.
Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.
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 (Investigator)
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
- •Pregnant at time of enrollment
- •Planning to undergo a scheduled cesarean delivery
- •Desires to use the LNG-IUS for contraception
- •Willing and able to sign an informed consent in English
- •Willing to comply with the study protocol
- •Age greater than or equal to 18 years
- •English speaking
排除标准
- •Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS
- •Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result
- •Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS
- •Uterine anomaly which would not allow placement of the LNG-IUS
- •Current cervical cancer or carcinoma in-situ
- •Desire for repeat pregnancy in less than 12 months
- •History of postabortal or postpartum sepsis
研究组 & 干预措施
postplacental insertion after cesarean
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
干预措施: Levonorgestrel-releasing intrauterine system (LNG-IUS) (Device)
delayed insertion group
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
干预措施: Levonorgestrel-releasing intrauterine system (LNG-IUS) (Device)
结局指标
主要结局
Use of the LNG-IUS for Contraception
时间窗: 12 months after cesarean delivery
次要结局
- Satisfaction With LNG-IUS(12 months after cesarean delivery)
- Rates of Expulsion of the LNG-IUS(12 months after cesarean delivery)
- Perforation Rates(12 months after cesarean delivery)
- Satisfaction With LNG-IUS(6 months after cesarean delivery)