Condition category
Neonatal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D R M Timmermans

ORCID ID

Contact details

VU University Medical Centre
Afd Sociale Geneeskunde
Van der Boechorststraat 7
Amsterdam
1081 B
Netherlands

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

  1. 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.

  2. 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.

Additional files

Editorial Notes