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Completed

NCT Number: NCT01889550

Use of eHealth in Communication With Patients About Prenatal Diagnosis

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Department of Gynaecology and Obstetrics

Odense, Region Syddanmark, 5000, Denmark

About this study

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.

Part three is an effect measurement. The effect of the intervention is measured through a randomized controlled trail in which the essentials of the measurement will be the pregnant women's knowledge and behavior in relation to prenatal diagnosis. Twice 300 pregnant women will be included in the project.

Results:

The research aims at generating new knowledge about ways to inform pregnant women about prenatal diagnosis and prenatal screening. The expected results are:

  • Higher knowledge about prenatal diagnosis for the pregnant women.
  • Less difficulty in making an informed choice for the coming parents.
  • Easy access to high quality information.
  • Equity in access to high quality information.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women participating in screening for Downs syndorme

Exclusion criteria

  • 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

Treatment and study plan

Access to the website www.graviditetsportalen.dk

Behavioral

The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics.

Other names: Website

Access to the website www.ouh.dk

Behavioral

Access to the usual information from the hospital website

Primary outcomes

  1. Multidimensional measure of informed choice (MMIC)

    Time frame: 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

Secondary outcomes

  1. Decisional Conflict Scale

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

  2. WHO well-being index

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

  3. Cambridge Worry Scale

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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Acronym: HIIP

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2013
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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