Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR430; 2200.0085
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, single blind, controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Condition
Down syndrome, neural tube defect
Intervention
The offer of a prenatal screening test (either the nuchal translucency measurement, or the maternal serum screening test) by means of an information booklet and an oral explanation by the woman's midwife or gynaecologist
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Risk perception
2. Psychological well-being
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant women attending 1 of 44 participating midwifery or gynaecology practices from May 2001 to May 2003 were asked for their informed consent.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
3000
Participant exclusion criteria
1. Gestational age of more than 16 weeks
2. No command of the Dutch language
Recruitment start date
01/01/2000
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Centre
Amsterdam
1081 B
Netherlands
Sponsor information
Organisation
VU University Medical Center, EMGO-Institute and Department of Public and Occupational Health (Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
emgo@vumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2005 results on test uptake and participants' reasons in http://www.ncbi.nlm.nih.gov/pubmed/15662690
2. 2005 results on informed decision making about prenatal screening among participants in http://www.ncbi.nlm.nih.gov/pubmed/15915085
Publication citations
-
Results on informed decision making about prenatal screening among participants
van den Berg M, Timmermans DR, Ten Kate LP, van Vugt JM, van der Wal G, Are pregnant women making informed choices about prenatal screening?, Genet. Med., 7, 5, 332-338.
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van den Berg M, Timmermans DR, Kleinveld JH, Garcia E, van Vugt JM, van der Wal G, Accepting or declining the offer of prenatal screening for congenital defects: test uptake and women's reasons., Prenat. Diagn., 2005, 25, 1, 84-90, doi: 10.1002/pd.1090.