METHODS: Patients between 11 + 3 and 13 + 6 weeks of gestation attending the first-trimester screening at Department of Mother and Child, University Hospital Federico II, Naples, Italy have been recruited and randomly allocated to contingent screening or universal cell-free fetal DNA testing (cffDNA). Questionnaires to measure reassurance, satisfaction, and anxiety have been filled twice: (Q1) after randomization and (Q2) after receiving results. Anxiety was measured by an Italian-version short form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI); child-related anxiety was measured by the 11-item Pregnancy-Related Anxiety Questionnaire-Revised Regardless of Parity (PRAQ-R2 scale); fear of bearing a physically or mentally handicapped child was measured considering only four items (item 4, 9, 10, and 11) of the PRAQ-R2 scale.
RESULTS: 431 patients were recruited: 205 (49%) were randomized in the contingent screening arm, 226 (51%) in the cfDNA arm. Maternal reassurance, satisfaction, and anxiety were not different in the two groups.
CONCLUSIONS: A contingent screening for aneuploidies in the first trimester seems able to ensure the same maternal reassurance and satisfaction as a cfDNA analysis in the low-risk population and to not affect maternal anxiety.
方法:妊娠11+3至13+6周的患者在母婴科进行孕早期筛查,FedericoII大学医院,那不勒斯,意大利已被招募并随机分配到临时筛查或通用无细胞胎儿DNA测试(cffDNA)。问卷调查来衡量安慰,满意,和焦虑已经填补了两次:(Q1)随机分组后和(Q2)收到结果后。焦虑是通过Spielberger状态-特质焦虑量表(STAI)的状态量表的意大利语版本的简短形式来衡量的;与儿童相关的焦虑是通过11项妊娠相关的焦虑问卷(PRAQ-R2量表)进行测量的;仅考虑了四个项目(PRAQ量表的第4、9、10和11项)来衡量与身体或智障儿童的恐惧。
结果:招募了431名患者:205(49%)在特遣队筛查组中随机分配,226(51%)在cfDNA臂中。产妇放心,满意,焦虑在两组中没有差异。
结论:孕早期非整倍体筛查似乎能够确保低危人群中与cfDNA分析相同的产妇保证和满意度,并且不会影响产妇焦虑。