Risk perception, informed decision making, and psychological well-being of pregnant women who are offered prenatal screening for congenital defects

ISRCTN ISRCTN24427684
DOI https://doi.org/10.1186/ISRCTN24427684
Secondary identifying numbers NTR430; 2200.0085
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
03/07/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D R M Timmermans
Scientific

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

Study information

Study designRandomised, single blind, controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeScreening
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedDown syndrome, neural tube defect
InterventionThe 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 typeOther
Primary outcome measure1. Risk perception
2. Psychological well-being
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants3000
Key inclusion criteriaPregnant women attending 1 of 44 participating midwifery or gynaecology practices from May 2001 to May 2003 were asked for their informed consent.
Key exclusion criteria1. Gestational age of more than 16 weeks
2. No command of the Dutch language
Date of first enrolment01/01/2000
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Centre
Amsterdam
1081 B
Netherlands

Sponsor information

VU University Medical Center, EMGO-Institute and Department of Public and Occupational Health (Netherlands)
Hospital/treatment centre

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Email emgo@vumc.nl
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results on test uptake and participants' reasons 01/01/2005 Yes No
Results article results on informed decision making about prenatal screening among participants 01/05/2005 Yes No