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临床试验/NCT02706340
NCT02706340已完成不适用

Expulsion of Immediate Postplacental Copper Intrauterine Devices at Six Months: A Prospective Cohort Study (PPIUD)

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
309
试验地点
1
主要终点
The primary objective is to measure the rate of expulsion of the copper intrauterine device (TCu380A, marketed as ParaGard®) when placed within 10 minutes of placental delivery among women delivering at the University of Pennsylvania.

研究概览

简要总结

This is an observational study enrolling women who have had a copper intrauterine device placed immediately after childbirth. The study follows participants for 6 month in order to evaluate the primary outcome of IUD expulsion within 6 months of delivery.

详细描述

The purpose of the study is to measure the rate of expulsion of the copper intrauterine device (ParaGard®) when placed immediately after childbirth. Many women in the United States have unintended pregnancies. Long-acting reversible birth control methods, like the copper intrauterine device (IUD), help prevent unintended pregnancy. This is because, once in place, the copper IUD provides excellent pregnancy prevention, and women using it do not have to do anything extra to make sure it works (like taking a birth control pill every day, for example). The copper IUD is safe and well liked among women who use it. Around the world, women have been getting their IUD fitted right after childbirth for the past 20 years, and this practice has been shown to be safe. This service has been offered at HUP since early 2014. When the IUD is placed after birth, there is a chance that it could fall out, as the uterus shrinks back to its pre-pregnancy size. Women who get their IUD fitted right after childbirth will be observed, and describe the rate of IUD expulsion at 6 months postpartum. Factors associated with IUD expulsion will be noted. Adult pregnant women delivering at the Hospital of the University of Pennsylvania, desiring an immediate IUD, and willing to follow up 6 months after birth, will be eligible to participate.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult woman age 18 years or more
  • Pregnant, 24 weeks 0 days gestation or more OR who have had a delivery at 34 weeks 0 days gestation or more
  • Anticipating a delivery at the Hospital of the University of Pennsylvania
  • Desiring an immediate postplacental TCu380A IUD, OR who have given birth and received an immediate postplacental TCu380A IUD
  • Able and willing to give consent in English
  • Willing to follow up 6 months after delivery

排除标准

  • Allergy or contraindication to TCu380A
  • Known cervical cancer or carcinoma in situ
  • History of undiagnosed abnormal vaginal bleeding prior to pregnancy
  • Unwilling to follow up in the six months following delivery will be excluded
  • Additional exclusion criteria apply after delivery:
  • Preterm delivery (33 weeks 6 days gestation or less at birth)
  • Clinical diagnosis of chorioamnionitis or treatment for presumed chorioamnionitis
  • No longer desiring immediate postplacental TCu380A placement
  • Subjects aged less than 18 years
  • Men are excluded by the nature of this women's health research.

结局指标

主要结局

The primary objective is to measure the rate of expulsion of the copper intrauterine device (TCu380A, marketed as ParaGard®) when placed within 10 minutes of placental delivery among women delivering at the University of Pennsylvania.

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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