Department of Obstetrics & Gynaecology, National University Hospital, Singapore, Singapore.
Population, Policy and Practice, UCL Great Ormond Street Institute of Child Health, London, UK.
Prenat Diagn. 2023 Jan;43(1):42-50. doi: 10.1002/pd.6279. Epub 2022 Dec 28.
Poor knowledge and the lack of deliberation have been cited as reasons for women making uninformed choices about aneuploidy screening. Adequate pre-test counselling is of particular importance where non-invasive prenatal screening (NIPS) is being increasingly offered as a primary screening test.
Women attending the antenatal clinic with a singleton pregnancy below 14 weeks were randomised to receive routine counselling or the intervention-a 16-min educational video on aneuploidy screening before their consult. The primary outcome, rate of informed choice, was assessed using an adapted multidimensional measure of informed choice questionnaire, where informed choice was defined as good knowledge and value-consistent behaviour. Secondary outcomes included informed choice with deliberation, decisional conflict and anxiety.
Two hundred and eighty-six women were recruited. 69.8% of women in the intervention group made an informed choice compared with 53.6% in the control group (Risk Ratio [RR] 1.30, p = 0.014). A significantly higher number of women in the intervention group had good knowledge compared to controls (81% vs. 60.9%; RR 1.33, p = 0.001). Decisional conflict did not differ between groups, but women in the intervention group had higher anxiety scores (p < 0.001).
The study intervention was effective in helping women make informed choice. Qualitative studies to determine the reason for increased anxiety are needed.
Trial registry: ClinicalTrials.gov; Identifier: NCT05492981.
知识匮乏和缺乏深思熟虑被认为是女性在非整倍体筛查方面做出不明智选择的原因。在越来越多地将无创产前筛查 (NIPS) 作为主要筛查测试提供的情况下，充分的预测试咨询尤为重要。
在 14 周以下的单胎妊娠的产前诊所就诊的女性被随机分配接受常规咨询或干预 - 在咨询前接受 16 分钟的关于非整倍体筛查的教育视频。主要结局是知情选择的发生率，使用经过改编的多维知情选择问卷进行评估，其中知情选择定义为良好的知识和价值一致的行为。次要结局包括深思熟虑的知情选择、决策冲突和焦虑。
共招募了 286 名女性。干预组中 69.8%的女性做出了知情选择，而对照组中 53.6%的女性做出了知情选择（风险比 [RR] 1.30，p=0.014）。干预组中具有良好知识的女性比例明显高于对照组（81%比 60.9%；RR 1.33，p=0.001）。决策冲突在两组之间没有差异，但干预组的女性焦虑评分更高（p<0.001）。
研究干预措施有效地帮助女性做出知情选择。需要进行定性研究以确定焦虑增加的原因。
临床试验.gov；标识符：NCT05492981。
