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临床试验/NCT01439802
NCT01439802已完成4 期

Transcesarean IUD Insertion: A Prospective Cohort Study

Albert Einstein College of Medicine4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
90
试验地点
4
主要终点
Number of Participants With Expulsion of IUD

研究概览

简要总结

The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

详细描述

This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton gestation
  • greater than 35 weeks gestation
  • speaks English or Spanish
  • desires IUD for contraception
  • undergoing a cesarean delivery

排除标准

  • evidence of chorioamnionitis
  • history of chlamydia within this pregnancy

结局指标

主要结局

Number of Participants With Expulsion of IUD

时间窗: 6 week postpartum

Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

次要结局

  • Satisfaction of IUD Placement(6 months postpartum)
  • Number of Participants With Expulsion of IUD(6 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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