title: How important is consent in maternal serum screening for Down syndrome in France? Information and consent evaluation in maternal serum screening for Down syndrome: a French study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Département d'échographie et de Médecine foetale, 19 rue Louis Pasteur, CMCO-SIHCUS, Schiltigheim, Strasbourg, France. romain.favre3@wanadoo.fr
authors.forename: Romain
authors.initials: R
authors.lastname: Favre
authors.forename: Nathalie
authors.initials: N
authors.lastname: Duchange
authors.forename: Christophe
authors.initials: C
authors.lastname: Vayssière
authors.forename: Monique
authors.initials: M
authors.lastname: Kohler
authors.forename: Nicole
authors.initials: N
authors.lastname: Bouffard
authors.forename: Marie-Chrsitine
authors.initials: MC
authors.lastname: Hunsinger
authors.forename: Anne
authors.initials: A
authors.lastname: Kohler
authors.forename: Cécile
authors.initials: C
authors.lastname: Mager
authors.forename: Muriel
authors.initials: M
authors.lastname: Neumann
authors.forename: Christine
authors.initials: C
authors.lastname: Vayssière
authors.forename: Brigitte
authors.initials: B
authors.lastname: Viville
authors.forename: Christian
authors.initials: C
authors.lastname: Hervé
authors.forename: Grégoire
authors.initials: G
authors.lastname: Moutel
mesh_terms: D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood*; D004314:Down Syndrome / Q000097:blood / Q000175:diagnosis*; D004522:Educational Status; D005260:Female; D005602:France; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000523:psychology; D016015:Logistic Models; D008403:Mass Screening; D010353:Patient Education as Topic; D011247:Pregnancy; D011296:Prenatal Diagnosis / Q000379:methods*; D011795:Surveys and Questionnaires
chemical_list: D015415:Biomarkers