search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number1365
- NTR NumberNTR430
- ISRCTNISRCTN24427684
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR2-sep-2005
- Secondary IDs2200.0085 
- Public TitleRisk perception, informed decision making, and psychological well-being of pregnant women who are offered prenatal screening for congenital defects.
- Scientific TitleRisk perception, informed decision making, and psychological well-being of pregnant women who are offered prenatal screening for congenital defects.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedDown syndrome, Neural tube defect
- Inclusion criteriaPregnant women attending 1 of 44 particpating midwifery or gynaecology practices from May 2001 to May 2003 were asked for their informed consent.
- Exclusion criteria1. Gestational age of more than 16 weeks;
2. No command of the Dutch language.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2000
- planned closingdate31-dec-2005
- Target number of participants3000
- InterventionsThe 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.
- Primary outcome1. Risk perception;
2. Psychological well-being.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. D.R.M. Timmermans
- CONTACT for SCIENTIFIC QUERIESDr. D.R.M. Timmermans
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications1. Accepting or declining the offer of prenatal screening for congenital defects: test uptake and women's reasons. van den Berg M, Timmermans DR, Kleinveld JH, Garcia E, van Vugt JM, van der Wal G. Prenatal Diagnosis 2005;25(1):84-90.
2. Are pregnant women making informed choices about prenatal screening? van den Berg M, Timmermans DR, Ten Kate LP, van Vugt JM, van der Wal G. Genetics in Medicine 2005;7(5):332-8.
3. Prenatal Diagnosis (in press). Johanna H. Kleinveld, Danielle R.M. Timmermans, Denhard J. de Smit, Herman J. Adèr, Gerrit van der Wal , Leo P. ten Kate. Does prenatal screening influence anxiety levels of pregnant women? A longitudinal randomised controlled trial.
- Brief summaryThe main reasons to accept prenatal screening were knowledge and test characteristics;
the main reasons to decline prenatal screening were unfavorable test characteristics, anxiety/uncertainty, and adverse characteristics of invasive testing.
The role of risk perception in the decision to accept or decline prenatal screening is limited.
Offering prenatal screening does not seriously affect anxiety levels of pregnant women.
- Main changes (audit trail)
- RECORD5-sep-2005 - 9-okt-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl