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临床试验/NCT02067663
NCT02067663已完成不适用

Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
1
主要终点
IUD Expulsion Rate

研究概览

简要总结

The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization?

The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women age ≥ 18
  • Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement
  • English or Spanish speaking
  • Willing to attend 2 follow-up visits

排除标准

  • Multiple gestations
  • Delivery prior to 35 weeks gestational age
  • Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper)
  • Cesarean delivery
  • Postpartum hemorrhage (estimated blood loss > 500 mL)
  • Chorioamnionitis
  • Abnormal uterine anatomy (including uterine anomaly or large fibroids)
  • Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test
  • Current cervical cancer or carcinoma in situ
  • Current breast cancer
  • Wilson's disease
  • If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand

研究组 & 干预措施

Mirena Group

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

干预措施: Mirena (Drug)

Paragard Group

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

干预措施: Paragard (Device)

结局指标

主要结局

IUD Expulsion Rate

时间窗: 3 months postpartum

The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.

次要结局

  • Intrauterine Device Expulsion by 12 Weeks Postpartum(12 weeks)
  • Intrauterine Device Expulsion (6 Weeks)(6 weeks)
  • Complications(3 months)
  • Satisfaction(3 months)
  • Pregnancy(3 months)
  • Intrauterine Device Expulsion (Day 1)(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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