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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01889550
Other study ID # HIIP
Secondary ID
Status Completed
Phase N/A
First received June 19, 2013
Last updated October 15, 2014
Start date August 2013
Est. completion date August 2014

Study information

Verified date October 2014
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 1150
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Access to the website www.graviditetsportalen.dk
The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics.
Access to the website www.ouh.dk
Access to the usual information from the hospital website

Locations

Country Name City State
Denmark Odense University Hospital, Department of Gynaecology and Obstetrics Odense Region of Southern Denmark

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Multidimensional measure of informed choice (MMIC) Questionnaire for assessing knowledge of prenatal screening for Downs syndrome Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan. No
Secondary 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. No
Secondary 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. No
Secondary 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. No
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