A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Continuation Rates
研究概览
简要总结
The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).
详细描述
The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement.
The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement.
Secondary outcome measures that we will obtain include:
- Pain at the time of placement
- Postpartum Depression
- Breastfeeding status
- Postpartum weight retention
- Expulsion Rates
- Bleeding Profile
- Uterine Infection(Endometritis)
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
- 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
- •All women >37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in our study.
排除标准
- •Contraindications to the LNG-IUS include:
- •Pregnancy or suspicion of pregnancy
- •Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- •Postpartum endometritis within the past 3 months
- •Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear
- •untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections
- •acute liver disease or liver tumor
- •hypersensitivity to any component of the product
- •known or suspected carcinoma of the breast
- •Any of these conditions would exclude the patient from receiving these forms of contraception in our study.
- •In addition the following intrapartum findings, the following would exclude the patient:
- •Delivery <37 weeks
- •Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
- •Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery or >1000cc for cesarean delivery)
研究组 & 干预措施
Immediate
LNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum
干预措施: LNG-IUS (Device)
Interval
LNG-IUS insertion after 6 weeks postpartum
干预措施: LNG-IUS (Device)
结局指标
主要结局
Continuation Rates
时间窗: 6 months
Primary objective: Determine if there is a difference in continuation rates at six months postpartum in women who have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two time periods: Immediate (after delivery of placenta to 72 hours postpartum) or Interval (after 6 weeks postpartum). Our analysis will be conducted on all randomized women on an intention to treat basis. Once insertion has occurred, evaluation at 6 months postpartum with the presence or absence of the LNG-IUS in the uterus will be determined to calculate the continuation rate.
次要结局
- Expulsion Rate(6 months)
- Breastfeeding Status(6 months)
- Postpartum weight retention(6 months)
- Sexual Function(6 months)
- Bleeding Profile(6 months)
- Infectious morbidity(6 months)
- Postpartum Depression(6 months)
- Pain at insertion(1 minute)