Risk perception, informed decision making, and psychological well-being of pregnant women who are offered prenatal screening for congenital defects
ISRCTN | ISRCTN24427684 |
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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
Scientific
VU University Medical Centre
Afd Sociale Geneeskunde
Van der Boechorststraat 7
Amsterdam
1081 B
Netherlands
Study information
Study design | Randomised, single blind, controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Screening |
Scientific title | |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 1. Risk perception 2. Psychological well-being |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2000 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 3000 |
Key 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. |
Key exclusion criteria | 1. Gestational age of more than 16 weeks 2. No command of the Dutch language |
Date of first enrolment | 01/01/2000 |
Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1081 B
Netherlands
1081 B
Netherlands
Sponsor information
VU University Medical Center, EMGO-Institute and Department of Public and Occupational Health (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
emgo@vumc.nl | |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |