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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Access to the website www.graviditetsportalen.dk | Active Comparator | 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 | Placebo Comparator | Access to the usual information from the hospital website |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette Maria Skjoeth, PhD Student | Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics | Principal Investigator |
| Jan Stener Joergensen, Associate professor | Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics | Study Chair |
| Claus Duedal Pedersen, Head of Innovation Unit | Odense University Hospital, The LEAN and Innovation Unit | Study Chair |
| Eva Draborg, Associate professor | University of Southern Denmark, Centre of Health Economics Research - Institute of Public Health | Study Chair |
| Helle Ploug Hansen, Professor | University of Southern Denmark, The Institute of Public Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital, Department of Gynaecology and Obstetrics | Odense | Region Syddanmark | 5000 | Denmark |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Access to the website www.ouh.dk | Behavioral | Access to the usual information from the hospital website |
|
| 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. |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |