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临床试验/NCT01889550
NCT01889550已完成不适用

Use of eHealth in Communication With Patients About Prenatal Diagnosis. An Intervention Study Carried Out in a Highly Specialised Unit for Obstetrics

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 1,150 人开始时间: 2013年8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
1,150
试验地点
2
主要终点
Multidimensional measure of informed choice (MMIC)

研究概览

简要总结

The research aims at generating new knowledge about ways to inform pregnant women about prenatal screening for Downs syndrome.

The overall purpose of this project is to increase pregnant women's knowledge of prenatal screening for Downs syndrome, and thereby an option to make an informed choice. The project is planned as a research into whether the use of an eHealth solution (in this project an interactive website) may be an appropriate intervention for pregnant women.

详细描述

Prenatal screening and diagnosis is testing for diseases or rare conditions in the fetus before birth. The aim is to assist the pregnant women to make their own decisions, and neutral and adequate counseling is a prerequisite during prenatal diagnosis. To make an informed choice, the pregnant women must be informed about the benefits and potential disadvantages of prenatal diagnosis and with this background be able to make a comprehensive evaluation, where ethical values will have a high impact.

The overall purpose of this project is to increase pregnant women's knowledge of prenatal screening for Downs syndrome, and thereby an option to make an informed choice. The project is planned as a research into whether the use of an eHealth solution (in this project an interactive website) may be an appropriate intervention for pregnant women.

Methods:

Part one consists of an identification of the problem

Part two consists of developing a website with relevant information about prenatal screening for Downs syndrome.

研究设计

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

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

  • Pregnant women participating in screening for Downs syndorme

排除标准

  • Respondents who do not speak, read and understand Danish.
  • Respondents who have opted out of health care services and prenatal diagnosis.
  • Reespondenter who do not wish to participate.
  • Respondents under 18 years.
  • Respondents with a strong suspicion of threatening abortion
  • Respondents whom are vulnerable
  • Respondents with a late referral

结局指标

主要结局

Multidimensional measure of informed choice (MMIC)

时间窗: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.

Questionnaire for assessing knowledge of prenatal screening for Downs syndrome

次要结局

  • Cambridge Worry Scale(Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.)
  • Decisional Conflict Scale(Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.)
  • WHO well-being index(Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.)

研究者

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

Mette Maria Skjoeth

PhD Student

Odense University Hospital

研究点 (2)

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