|- candidate number||1365|
|- NTR Number||NTR430|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||2-sep-2005|
|- Secondary IDs||2200.0085 |
|- Public Title||Risk perception, informed decision making, and psychological well-being of pregnant women who are offered prenatal screening for congenital defects.|
|- Scientific Title||Risk perception, informed decision making, and psychological well-being of pregnant women who are offered prenatal screening for congenital defects.|
|- Healt Condition(s) or Problem(s) studied||Down syndrome, Neural tube defect|
|- Inclusion criteria||Pregnant women attending 1 of 44 particpating midwifery or gynaecology practices from May 2001 to May 2003 were asked for their informed consent.|
|- Exclusion criteria||1. Gestational age of more than 16 weeks;|
2. No command of the Dutch language.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2000|
|- planned closingdate||31-dec-2005|
|- Target number of participants||3000|
|- Interventions||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.|
|- Primary outcome||1. Risk perception;|
2. Psychological well-being.
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. D.R.M. Timmermans|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D.R.M. Timmermans|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||1. 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 summary||The 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)|
|- RECORD||5-sep-2005 - 9-okt-2008|