Research with human participants

Overview of medical research in the Netherlands

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

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON26208

Source

NTR

Brief title

N/A

Health condition

Down syndrome, neural tube defects.

Sponsors and support

Primary sponsor :
VU University Medical Center,
EMGO-institute,
Dept of Public and Occupational Health
Source(s) of monetary or material Support :
ZonMw Prevention Program.

Intervention

Outcome measures

Primary outcome

1. Risk perception;

2. Psychological well-being.

Secondary outcome

N/A

Background 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.

Study objective

N/A

Study design

N/A

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.

Public
VU University Medical Center,
Department of Social Medicine,
Van der Boechorststraat 7
D.R.M. Timmermans
Van der Boechorststraat 7

Amsterdam 1081 BT
The Netherlands
+31 (0)20 4448384
Scientific
VU University Medical Center,
Department of Social Medicine,
Van der Boechorststraat 7
D.R.M. Timmermans
Van der Boechorststraat 7

Amsterdam 1081 BT
The Netherlands
+31 (0)20 4448384

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.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
3000
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL390
NTR-old NTR430
Other : 2200.0085
ISRCTN ISRCTN24427684

Summary results

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. <br>
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.
<br>
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.