What about informed consent in first-trimester ultrasound screening for Down syndrome?

Objectives: We evaluate the level of information and informed consent given for the screening of Down syndrome (DS) before the first-trimester ultrasound scan. We evaluate the nature of the medical information given and the patient's understanding. This makes it possible to analyze the existence of the necessary elements ( level of information and consent) for the patients to exercise their autonomy as to their decision making during the first-trimester ultrasound scan. Methods: A total of 350 patients were recruited prospectively in 2 hospitals. Patients were divided into 3 groups according to the results of maternal serum screening for DS. Group 1: Patients at high risk of having a child with DS with the second-trimester maternal serum screening ( MSS) ( risk > 1/250). Group 2: Patients having a low risk ( risk < 1/250). Group 3: Patients who did not undergo maternal serum screening test. A questionnaire was completed before the medical consultation, to assess the quality of the medical consultation before the ultrasound, the level of prior knowledge and the maternal consent. Results: We excluded 45 of the 350 questionnaires from the analysis because they were incomplete ( 13.1%). We therefore analyzed a total of 305 questionnaires. The three groups analysed were: Group 1: 89 patients ( 29.2%) identified as at high risk after MSS. Group 2: 137 patients ( 44.9%) identified as at low risk accordingly to MSS. Group 3: 79 women ( 25.9%) who did not undergo maternal serum screening test for diverse reasons. The frequency of genuine informed consent was significantly ( p < 0.001) higher in group 3 ( 56.9%) than in group 1 ( 52.8%) or group 2 ( 32.1%). Finally, the number of completely uninformed patients was significantly higher in group 2 ( 18%) than in the other two groups ( 7.8% for group 1 and 6.3% for group 3, p ! 0.001). With multiple regression analysis, we found that maternal consent depended on 4 independent components: ( 1) Educational level ( ! baccalaureate, baccalaureate or at least 2 years of higher education after baccalaureate) ( p < 0.03). ( 2) The location of consultations ( hospital or private doctor's practice) ( p < 0.01). ( 3) History of medical termination ( p < 0.001). ( 4) The score attributed to the doctor for information about early ultrasound scans ( p < 0.001). The rate of consent increased with increasing educational level and was higher for women consulting at a hospital, for women with a history medical termination and for women whose doctors had a high score. Other criteria such as belonging to group 1, 2 or 3, age of the patient, first language, number of children, history of miscarriage, sex and age group of the professionals were not found significant. Conclusions: The response to the question 'Is the level of medical information provided to patients concerning early screening by first-trimester ultrasound scans appropriate?' is 'no'. There is no difference in our result according to social-economic level. However, educational level ( 66% consent for patients with 2 years of higher education after the baccalaureate), a history of medical termination ( 85% consent), being followed at a hospital ( 77% consent) and the score of the doctor ( 71% consent) were all significantly associated with the level of consent to prenatal screening. It is difficult for patients to exercise their autonomy as concerns first-trimester ultrasound scans. Too many patients ( 82%) consider such scans to be compulsory. Overall, the level of knowledge of the patients was moderate, with 227 of the 305 patients( 74%) having a satisfactory knowledge score ( 6 10). The negative responses to the various questions calls into question the legitimacy of consent for first-trimester ultrasound scans, particularly as concerns the measurement of nucal translucency.