Favre Romain, Duchange Nathalie, Vayssière Christophe, Kohler Monique, Bouffard Nicole, Hunsinger Marie-Chrsitine, Kohler Anne, Mager Cécile, Neumann Muriel, Vayssière Christine, Viville Brigitte, Hervé Christian, Moutel Grégoire
Département d'échographie et de Médecine foetale, 19 rue Louis Pasteur, CMCO-SIHCUS, Schiltigheim, Strasbourg, France.
Prenat Diagn. 2007 Mar;27(3):197-205. doi: 10.1002/pd.1656.
To evaluate the level of information and informed consent for maternal serum screening (MSS) for Down syndrome (DS) in the second trimester of pregnancy and analyse the exercise of autonomy towards the test by the women concerned.
We studied the population of pregnant women attending obstetric consultations in two French hospitals over a 3-month period. The women were assigned to three groups according to MSS results for DS: women at high risk of having a child with DS (group 1), women at low risk (group 2) and women who did not undergo the test (group 3). A questionnaire was completed before the medical consultation, to assess the quality of consent before amniocentesis for the group at high risk and before the second-trimester ultrasound scan for the other two groups.
We analysed 305 questionnaires for 89, 137 and 79 women belonging to groups 1, 2 and 3 respectively. In total, 123 women (40.3% [IC 95%, 35-46%]) were considered to be well informed; 33 (10%, [IC 95%, 8-12%]) had a high level of knowledge, but made choices not consistent with their stated attitude, and 149 (49.7% [IC 95%, 45-56%]) were considered uninformed. Logistic regression analysis showed that maternal consent depended on three independent components: The score attributed to the doctor for information about MSS (t = 4.216, p < 0.001). Whether the patient belonged to group 1 (t = -2.631, p < 0.009). Educational level (< high-school diploma, high-school diploma or at least two years of higher education after high school) (t = 2.324, p < 0.02). The rate of consent increased with educational level and was highest for the women in group 1 and for those whose doctor had a high information score.
Our findings clearly show that women are provided with insufficient information concerning MSS screening for DS in the second trimester of pregnancy for real and valid consent to be obtained.
评估孕中期唐氏综合征（DS）血清学筛查（MSS）的信息水平和知情同意情况，并分析相关女性对该项检查自主决定权的行使情况。
我们对两家法国医院三个月内产科门诊的孕妇群体进行了研究。根据DS的MSS结果，将这些女性分为三组：生育DS患儿高危女性（第1组）、低危女性（第2组）和未接受该项检查的女性（第3组）。在进行医学咨询前完成一份问卷，以评估高危组羊膜穿刺术以及其他两组孕中期超声检查前的知情同意质量。
我们分别分析了第1、2、3组中89名、137名和79名女性的305份问卷。总体而言，123名女性（40.3%[95%置信区间，35 - 46%]）被认为信息充分；33名（10%，[95%置信区间，8 - 12%]）知识水平较高，但做出的选择与其陈述的态度不一致，149名（49.7%[95%置信区间，45 - 56%]）被认为信息不足。逻辑回归分析表明，产妇的同意取决于三个独立因素：医生在MSS信息方面的得分（t = 4.216，p < 0.001）。患者是否属于第1组（t = -2.631，p < 0.009）。教育水平（高中文凭以下、高中文凭或高中后至少两年高等教育）（t = 2.324，p < 0.02）。同意率随教育水平提高而增加，第1组女性以及医生信息得分高的女性同意率最高。
我们的研究结果清楚地表明，在孕中期针对DS的MSS筛查方面，女性所获得的信息不足，无法获得真实有效的同意。
Zotero 插件