BACKGROUND: The Norwegian Biotechnology Act distinguishes between ultrasound as part of routine antenatal care and fetal diagnostic ultrasound. The Act is criticised for being unclear and difficult to comply with in clinical practice. The purpose of this study was to investigate whether doctors complied with the guidelines in the Biotechnology Act when they considered the case histories of women who wanted early ultrasound with fetal diagnosis. MATERIAL AND METHOD: We asked gynaecologists in private practice, experts in fetal medicine and lawyers and consultants in the Department of Biotechnology and Health Law at the Norwegian Directorate of Health to evaluate six hypothetical cases of women who wanted early ultrasound. RESULTS: We received responses from 64 of 139 (49 %) of private gynaecologists, 22 of 27 (81 %) of doctors at fetal medicine centres and 5 of 12 (42 %) respondents at the Directorate of Health. Only 29 of 86 (34 %) of the doctors responded that they strictly comply with the age criterion of 38 years. 33 of 64 /52 %) of private gynaecologists would measure nuchal translucency themselves, and 43 of 64 (67 %) have referred patients for fetal diagnosis on the indication of "anxiety". 16 of 22 (73 %) of doctors at fetal medicine centres were of the view that anxiety is an indication for fetal diagnostics. All respondents at the Directorate of Health responded that this is not correct according to the guidelines. INTERPRETATION: The majority of doctors did not strictly comply with the guidelines when they evaluated the case histories, and the guidelines were interpreted differently by doctors and respondents at the Directorate of Health.
BACKGROUND: The Norwegian Biotechnology Act distinguishes between ultrasound as part of routine antenatal care and fetal diagnostic ultrasound. The Act is criticised for being unclear and difficult to comply with in clinical practice. The purpose of this study was to investigate whether doctors complied with the guidelines in the Biotechnology Act when they considered the case histories of women who wanted early ultrasound with fetal diagnosis. MATERIAL AND METHOD: We asked gynaecologists in private practice, experts in fetal medicine and lawyers and consultants in the Department of Biotechnology and Health Law at the Norwegian Directorate of Health to evaluate six hypothetical cases of women who wanted early ultrasound. RESULTS: We received responses from 64 of 139 (49 %) of private gynaecologists, 22 of 27 (81 %) of doctors at fetal medicine centres and 5 of 12 (42 %) respondents at the Directorate of Health. Only 29 of 86 (34 %) of the doctors responded that they strictly comply with the age criterion of 38 years. 33 of 64 /52 %) of private gynaecologists would measure nuchal translucency themselves, and 43 of 64 (67 %) have referred patients for fetal diagnosis on the indication of "anxiety". 16 of 22 (73 %) of doctors at fetal medicine centres were of the view that anxiety is an indication for fetal diagnostics. All respondents at the Directorate of Health responded that this is not correct according to the guidelines. INTERPRETATION: The majority of doctors did not strictly comply with the guidelines when they evaluated the case histories, and the guidelines were interpreted differently by doctors and respondents at the Directorate of Health.