Authors' recommendations: In this advisory report the Committee on Population Screening of the Health Council of the Netherlands appraised a license application of the University Medical Centre in Groningen for a scientific study concerning the value of prenatal screening on congenital foetal defects with a so-called first-trimester anomaly scan. The minister asked the Health Council for advice concerning this study on 11 July 2014. Since 2007 all pregnant women get an offer to screen for foetal anomalies with an ultrasound at twenty weeks pregnancy (i.e. a secondtrimester anomaly scan). The scan around twenty weeks leaves the pregnant woman little time for decisions concerning the pregnancy, because after week 24 of the pregnancy the pregnancy can only be terminated if the foetus is not viable or if there is a life threatening situation for the pregnant women. The license application concerns a study into the first-trimester anomaly scan around week 13 of the pregnancy. The first-trimester anomaly scan provides pregnant women with more time for difficult decisions concerning the pregnancy if foetal defects are indeed found. Therefore the committee finds that the research in this application is important for public health and science. The Committee appraised the study by evaluating the legal requirements concerning the scientific soundness, actions in accordance with the relevant laws and the benefit-harm ratio. It was decided that the requirements of the Screening Act were met and the Committee advices the minister to grant the requested license. It is important that the pregnant women are informed well about the difference between participation in the scientific study and in the usual second-trimester anomaly scan. It is also important to stress the scientific importance that the anomalies detected during the first and second trimester scans are verified or falsified by adequate diagnostic work-up during or after pregnancy, under the condition that consent of the pregnant women is obtained.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.gr.nl/sites/default/files/summary_201431wbo_prenatale_screening_met_een_dertienwekenecho.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Netherlands

Organisation Name: Health Council of the Netherlands Gezondheidsraad

Contact Address: Postbus 16052, 2500 BB Den Haag, The Netherlands. Tel: +31 70 340 7520;Fax: +31 70 340 7523

Contact Name: info@gr.nl

Contact Email: info@gr.nl

Copyright: Health Council of the Netherlands