Eurofetus: an evaluation of routine ultrasound screening for the detection of fetal defects. Aims and method

The aims of this study are (1) to evaluate the efficiency of ultrasound in detecting CA in low-risk populations of pregnant women by routine screening performed in hospital ultrasound labs (level II); (2) to highlight the areas where improvement could be obtained; (3) to determine efficient timing and number of examinations; (4) to evaluate the psychological returns of detection and nondetection of CA; and (5) to evaluate the cost-effectiveness ratio of antenatal screening of CA. A European collaboration was supposed to help in meeting these objectives because results concerning the analysis of individual CAs or groups of CAs can only be statistically significant when their number is sufficiently large. It was estimated that it was necessary to collect nearly 5,000 CA; this corresponds to about 200,000 pregnant women, the prevalence of malformations at birth being estimated at 2.5%. These conditions yield worthy conclusions, given the following circumstances: a large variety of CA, the extremely low incidence of each CA, the multiple approaches for diagnosis and management, the manifold classes of defects, the differences in gestational age when anomalies are detectable and detected. We study prospectively (1) the reliability of ultrasound in detecting antenatal malformations by recording all CA, ultrasonically suspected and not; (2) the gestational age of anomaly recognition; (3) the response to antenatal diagnosis of CA; (4) the individual outcome of pregnancies; (5) the financial cost of the screening program; and (6) the psychological consequences for the parents.