Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
研究概览
简要总结
This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Desiring a LNG-IUS
- •Postpartum, ages 18-45 who deliver at a gestational age > 32 weeks, delivery can be via cesarean or vaginal delivery
- •Following a viable, singleton pregnancy
- •Willing to return to UNC for their LNG-IUS insertion and study follow-up
- •Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits
- •Fluent in English or Spanish
- •At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)
排除标准
- •No genital bleeding of unknown etiology
- •No personal history of known or suspected breast carcinoma
- •No 4th degree vaginal laceration at time of delivery
- •No documented uterine rupture during delivery
- •No active liver disease (resolved pre-eclampsia may enroll)
- •No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion
- •No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage
- •No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4
- •Not currently incarcerated
- •No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
- •No suspected hypersensitivity or contraindication to the LNG-IUS
- •With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study.
研究组 & 干预措施
LNG-IUS placed at 2 weeks postpartum
Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum
干预措施: Levonorgestrel Intrauterine System (LNG-IUS) (Drug)
结局指标
主要结局
Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
时间窗: 6 months postpartum
A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"
Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.
时间窗: Day 14-20 postpartum
Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?
次要结局
- Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.(6 months postpartum)