TRIDENT study: Trial by Dutch laboratories for Evaluation of Non-Invasive Prenatal Testing (NIPT)

TRIDENT study: Trial by Dutch laboratories for Evaluation of Non-Invasive Prenatal Testing (NIPT)

Background

Starting date: 01/04/2014

 

NIPT
Non-Invasive Prenatal Testing (NIPT) analyses circulating fragments of fetal DNA in maternal plasma, obtained by a blood sample of the pregnant woman. NIPT can now be used to test for trisomy 21 (Down syndrome), 18 and 13 in the foetus.

NIPT in the Netherlands
In the Netherlands, NIPT is available within the TRIDENT-1 study (Trial by Dutch laboratories for Evaluation of Non-Invasive Prenatal Testing) for women who are at an elevated risk of carrying a fetus with Down syndrome (or trisomy 18 or 13) based on the first trimester combined test (FCT) with a cut-off of 1:200 (www.meeroverNIPT.nl). In addition, women with a previous child with a trisomy 13, 18 or 21 or carriers of Robertsonian translocations involving chromosome 21 or 13, can have direct access to NIPT.

Since April 1st 2017 NIPT is available for every pregnant woman in the Netherlands within the TRIDENT-2 study.

TRIDENT studies
The TRIDENT studies have been designed and are carried out by the Dutch National NIPT consortium (www.NIPTconsortium.nl).
A license for the TRIDENT-1 study for high-risk women has been granted for two years (starting April 1, 2014) by the Ministry of Health, according to the rules of the Population Screening Act, and after positive advice had been given by the Health Council of the Netherlands (see report). In 2016, the license was extended for another two years. Depending on the outcome of the study, NIPT will be fully implemented in health care.
The TRIDENT-2 study was granted for 3 years (2017-2020).


See also study Objectives, MethodsStaff, and Publications