Use of eHealth in Communication With Patients About Prenatal Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Downs Syndrome Health Knowledge, Attitudes, Practice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Access to the website www.graviditetsportalen.dk

Intervention Type BEHAVIORAL

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

Group Type PLACEBO_COMPARATOR

Access to the website www.ouh.dk

Intervention Type BEHAVIORAL

Access to the usual information from the hospital website

Interventions

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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.

Intervention Type BEHAVIORAL

Access to the website www.ouh.dk

Access to the usual information from the hospital website

Intervention Type BEHAVIORAL

Other Intervention Names

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Website

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Mette Maria Skjoeth

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette Maria Skjoeth, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics

Jan Stener Joergensen, Associate professor

Role: STUDY_CHAIR

Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics