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 |
| Protocol serial number | NTR430; 2200.0085 |
| Sponsor | VU University Medical Center, EMGO-Institute and Department of Public and Occupational Health (Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single blind, controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Risk perception |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
