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临床试验/NCT02054195
NCT02054195已完成4 期

Study of Special Guided Training Model on Insertion Techniques for Postplacental Intra Uterine Device to Prevent Expulsion

Showa University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
230
试验地点
1
主要终点
Number of Participants with IUD total or partial expulsion

研究概览

简要总结

This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion

详细描述

The standard of insertion IUD postplacental can not provide prevention of expulsion. Special techniques on insertion IUD is needed for preventing expulsion. This training model is consisted of the special techniques to provide intra uterine device post placental close enough to fundal part of uterus to prevent expulsion

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly

排除标准

  • •Any bleeding and infection complication

研究组 & 干预措施

IUD new technique

Experimental

Training

干预措施: Training (Behavioral)

No Training

Experimental

No Training

干预措施: No Training (Behavioral)

结局指标

主要结局

Number of Participants with IUD total or partial expulsion

时间窗: 12 Months

Transabdominal ultrasonography examination was done by researcher right after insertion. Ultrasonography examination was done using longitudinal and transversal scan, with client in supine position using real time convex 2 probe with 3,5 Mhz frequency. While transvaginal ultrasonography examination was done when the client come after 6 weeks, 6 months and 12 months after insertion.

次要结局

  • Percentage of Participants with retained skill and knowledge(12 Months)

研究者

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

Yuditiya Purwosunu

MD

Showa University

研究点 (1)

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