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临床试验/NCT05594108
NCT05594108已完成不适用

Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency

University of Saskatchewan2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
post procedure pain score

研究概览

简要总结

The objective of this pilot study is to test that hypothesis that ultrasound guided IUD placement by family medicine residents improves patient pain scores, procedure completion time, and procedure complication rates. The secondary objective is to test the hypothesis that ultrasound guided IUD placement improves resident confidence in performing the procedure. A prospective, randomized controlled pilot study will be conducted in the Department of Academic Family Medicine at the University of Saskatchewan. All women undergoing IUD placement (hormonal or non-hormonal) at West Winds Primary Care Center from Mar 1, 2020- Mar 1, 2021 will be invited to participate. Informed consent will be obtained from each patient and the resident inserting the IUD prior to initiating study procedures. The control group will comprise 20 women undergoing non-ultrasound guided IUD placement. The experimental group will comprise 20 women undergoing transabdominal ultrasound guided IUD placement. Patient pain scores and resident confidence scores will be tabulated using likert scales and compared between control and experimental groups using independent sample t-tests. Procedure completion time (minutes) will be compared between groups using t-tests. Procedure complications rates will be categorized as: a) inability to penetrate the cervix, b) improper location, c) inability to release the IUD from the insertion device, d) perforation, e) vasovagal reactions, and f) post-procedure infection; outcomes will be compared between groups using Chi-square analyses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • all women of pre or perimenopausal age undergoing IUD (hormonal or non-hormonal) placement at West Winds Primary Care Center from Mar1, 2020 to Mar1, 2021

排除标准

  • pregnancy, < 6 weeks postpartum

结局指标

主要结局

post procedure pain score

时间窗: 3 years

patient pain, likert scale

次要结局

  • procedure completion time(3 years)
  • procedure complications(3 years)
  • residency confidence with procedure(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Baerwald

Assistant Professor

University of Saskatchewan

研究点 (2)

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