Table 1 Short description of the TRIDENT studies on the implementation of NIPT in The Netherlands

Background & study period

In the Netherlands, NIPT became available in April 1, 2014 as part of the first TRIDENT study for pregnant women with an indication for invasive diagnostic testing based on an increased risk for aneuploidy (e.g. Down syndrome)(risk ≥1:200) at first trimester combined screening. In addition, women with a medical history, e.g. previous child with Down syndrome can have direct access to NIPT. NIPT is offered after counselling to women attending one of the eight specialized Prenatal Diagnosis Units [11]. A two-year license, based on the Population Screening Act, was obtained from the Minister of Health, and later extended for another 2 years (2018).

As of April 2017, NIPT will be offered to all pregnant women irrespective of risk (TRIDENT-2 study). A three-year license for this study was obtained.

NIPT analyses

NIPT is performed by clinical genetic laboratories of the Dutch University Medical Centres, using (in-house validated) massively parallel shotgun sequencing.

Dutch NIPT Consortium

The TRIDENT studies were designed and proposed by the national multidisciplinary NIPT Consortium, formed in 2011. The NIPT Consortium is membered by all stakeholders involved in prenatal care (including obstetricians, clinical geneticists, midwives, laboratory specialists, the Dutch Genetic Alliance, ethicists, and researchers).

Study aim

To investigate all relevant aspects of the implementation of NIPT in the Dutch prenatal screening program. The studies will evaluate two parts:

Part I. Organization, logistics, test-performance, costs [11].

Part II. Women’s decision-making, uptake, preferences, psychosocial aspects [35].

Funding and cost

The laboratory tests for high-risk women were funded in 2014 by the Ministry of Health, but since 2015 covered by the insurance companies (women can be charged for their yearly compulsory own risk excess (385 euros)).

As of 2017, women will pay 175 euros for NIPT as a first-tier screening test.

The study evaluations are funded by The Netherlands Organisation for Health Research and Development (ZonMw, grants no. 200340002 (TRIDENT-1) and 543002001 (TRIDENT-2).