Pasupathy Dharmintra, Dacey Alison, Cook Emma, Charnock-Jones D Stephen, White Ian R, Smith Gordon C S
Department of Obstetrics and Gynaecology, University of Cambridge, Cambridge, UK.
BMC Pregnancy Childbirth. 2008 Nov 19;8:51. doi: 10.1186/1471-2393-8-51.
There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years. However, the approach to screening for other complications of pregnancy such as intra-uterine growth restriction, pre-eclampsia and stillbirth remains largely unchanged. Randomised controlled trials of routine application of high tech screening methods to the general population have generally failed to show improvement in outcome. We have previously reviewed this and concluded it was due, in large part, to poor performance of screening tests. Here, we report a study design where the primary aim is to generate clinically useful methods to screen women to assess their risk of adverse pregnancy outcome.
METHODS/DESIGN: We report the design of a prospective cohort study of unselected primiparous women recruited at the time of their first ultrasound scan. Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10-14 weeks), 20 weeks, 28 weeks and 36 weeks gestation. In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth. Data will be analysed as a prospective cohort study, a case-cohort study, and a nested case-control study.
The study is expected to provide a resource for the identification of novel biomarkers for adverse pregnancy outcome and to evaluate the performance of biomarkers and serial ultrasonography in providing clinically useful prediction of risk.
在过去20年里，非整倍体筛查方法发生了巨大变化。然而，针对其他妊娠并发症（如胎儿生长受限、先兆子痫和死产）的筛查方法基本没有改变。对普通人群常规应用高科技筛查方法的随机对照试验总体上未能显示出结局改善。我们之前对此进行了综述，并得出结论，这在很大程度上是由于筛查试验的性能不佳。在此，我们报告一项研究设计，其主要目的是生成临床上有用的方法来筛查女性，以评估她们发生不良妊娠结局的风险。
方法/设计：我们报告一项前瞻性队列研究的设计，该研究对象为在首次超声扫描时招募的未经选择的初产妇。参与研究包括在孕早期超声扫描（通常为10 - 14周）、20周、28周和36周时进行系列静脉采血和产科超声检查。此外，还会获取产妇的人口统计学详细信息；测量产妇和父亲的身高，并在孕期连续测量产妇体重；收集产妇、父亲和后代的DNA；在出生时收集胎盘和胎膜样本。数据将以前瞻性队列研究、病例队列研究和巢式病例对照研究的方式进行分析。
该研究有望为识别不良妊娠结局的新型生物标志物提供资源，并评估生物标志物和系列超声检查在提供临床上有用的风险预测方面的性能。
