■通过早期检测(改善)改善妊娠结局是一个多中心,欧洲IIa期临床研究。IMPROvED的主要目的是能够评估和改进基于新兴生物标志物技术的创新原型先兆子痫风险评估测试。在这里,我们描述了改进的个人资料,并邀请研究人员进行合作。
■从爱尔兰的产科中招募了4,038名低风险的单胎妊娠(N=1,501),英国(N=1,108),荷兰(N=810),瑞典(N=619),2013年11月至2017年8月。参与者在约11周接受研究助产士的采访(可选访问),~15周,~20周,妊娠约34周(可选就诊),和产后(分娩后72小时内)。
■临床数据包括有关孕产妇社会人口统计学的信息,病史,和在妊娠15周时收集的生活方式因素,和产妇测量,在每次研究访问时收集。生物库样本包括血液,尿液,和在整个怀孕期间在所有单位的每次研究访视时收集的头发,以及在爱尔兰和瑞典出生时收集的脐带/血液样本。总共74.0%(N=2,922)的人没有复杂的怀孕,3.1%(N=122)发生先兆子痫,3.6%(N=143)有自发性早产,10.5%(N=416)的婴儿小于胎龄儿。我们在妊娠15周和20周时评估了一组代谢物生物标志物和一组蛋白质生物标志物,用于先兆子痫风险评估。它们转化为具有临床应用的测试,由商业实体进行,受到技术问题和测试要求变化的阻碍。蛋白质面板上的工作被放弃了,而使用代谢物生物标志物进行子痫前期风险评估的工作正在进行中。
■根据改进研究的最初目标,这些数据和生物样本库现在可用于国际合作,以开展高质量的不良妊娠结局的原因和预防研究。
UNASSIGNED: Improved Pregnancy Outcomes via Early Detection (IMPROvED) is a multi-centre, European phase IIa clinical study. The primary aim of IMPROvED is to enable the assessment and refinement of innovative prototype preeclampsia risk assessment tests based on emerging biomarker technologies. Here we describe IMPROvED\'s profile and invite researchers to collaborate.
UNASSIGNED: A total of 4,038 low-risk nulliparous singleton pregnancies were recruited from maternity units in Ireland (N=1,501), United Kingdom (N=1,108), The Netherlands (N=810), and Sweden (N=619) between November 2013 to August 2017. Participants were interviewed by a research midwife at ~11 weeks (optional visit), ~15 weeks, ~20 weeks, ~34 weeks\' gestation (optional visit), and postpartum (within 72-hours following delivery).
UNASSIGNED: Clinical data included information on maternal sociodemographic, medical history, and lifestyle factors collected at ~15 weeks\' gestation, and maternal measurements, collected at each study visit. Biobank samples included blood, urine, and hair collected at each study visit throughout pregnancy in all units plus umbilical cord/blood samples collected at birth in Ireland and Sweden. A total of 74.0% (N=2,922) had an uncomplicated pregnancy, 3.1% (N=122) developed preeclampsia, 3.6% (N=143) had a spontaneous preterm birth, and 10.5% (N=416) had a small for gestational age baby. We evaluated a panel of metabolite biomarkers and a panel of protein biomarkers at 15 weeks and 20 weeks\' gestation for preeclampsia risk assessment. Their translation into tests with clinical application, as conducted by commercial entities, was hampered by technical issues and changes in test requirements. Work on the panel of proteins was abandoned, while work on the use of metabolite biomarkers for preeclampsia risk assessment is ongoing.
UNASSIGNED: In accordance with the original goals of the IMPROvED study, the data and biobank are now available for international collaboration to conduct high quality research into the cause and prevention of adverse pregnancy outcomes.