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The Welsh study of mothers and babies: protocol for a population-based cohort study to investigate the clinical significance of defined ultrasound findings of uncertain significance

机译:母亲和婴儿的威尔士研究:基于人群的队列研究的议定书,探讨了不确定意义鉴定超声检查的临床意义

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Background Improvement in ultrasound imaging has led to the identification of subtle non-structural markers during the 18 – 20?week fetal anomaly scan, such as echogenic bowel, mild cerebral ventriculomegaly, renal pelvicalyceal dilatation, and nuchal thickening. These markers are estimated to occur in between 0.6% and 4.3% of pregnancies. Their clinical significance, for pregnancy outcomes or childhood morbidity, is largely unknown. The aim of this study is to estimate the prevalence of seven markers in the general obstetric population and establish a cohort of children for longer terms follow-up to assess the clinical significance of these markers. Methods/Design All women receiving antenatal care within six of seven Welsh Health Boards who had an 18 to 20?week ultrasound scan in Welsh NHS Trusts between July 2008 and March 2011 were eligible for inclusion. Data were collected on seven markers (echogenic bowel, cerebral ventriculomegaly, renal pelvicalyceal dilatation, nuchal thickening, cardiac echogenic foci, choroid plexus cysts, and short femur) at the time of 18 – 20?week fetal anomaly scan. Ultrasound records were linked to routinely collected data on pregnancy outcomes (work completed during 2012 and 2013). Images were stored and reviewed by an expert panel. The prevalence of each marker (reported and validated) will be estimated. A projected sample size of 23,000 will allow the prevalence of each marker to be estimated with the following precision: a marker with 0.50% prevalence to within 0.10%; a marker with 1.00% prevalence to within 0.13%; and a marker with 4.50% prevalence to within 0.27%. The relative risk of major congenital abnormalities, stillbirths, pre-term birth and small for gestational age, given the presence of a validated marker, will be reported. Discussion This is a large, prospective study designed to estimate the prevalence of markers in a population-based cohort of pregnant women and to investigate associations with adverse pregnancy outcomes. The study will also establish a cohort of children that can be followed-up to explore associations between specific markers and longer-term health and social outcomes.
机译:背景技术超声成像的改善导致了在18 - 20?胎儿异常扫描中鉴定微妙的非结构标记,如回声肠,轻度脑腹部肠胃细胞,肾骨盆膨胀和颈部增厚。这些标志物估计发生在妊娠的0.6%和4.3%之间。他们的临床意义,用于怀孕结果或儿童发病率,主要是未知的。本研究的目的是估计一般产科人口中七个标记的患病率,并建立一个儿童队列,以便评估这些标志物的临床意义。方法/设计所有在七个威尔士健康委员会中接受产前产物护理的妇女,他们在2008年7月和2011年3月之间的威尔士NHS信托中的超声扫描有资格包含。在七个标记上收集数据(回声肠道,脑腹痛,肾骨盆扩张,颈部增厚,心脏回声焦点,脉络丛囊肿和短股骨)在18-20次胎儿异常扫描时。超声记录与常规收集的关于妊娠结算数据(2012年和2013年期间完成的工作)相关联。通过专家面板存储和审查图像。将估计每个标记(报告和验证)的患病率。预计的23,000的样品大小将允许通过以下精确度估算每个标记的患病率:患有0.50%的标记在0.10%以内;标记物在0.13%以内下降1.00%;和标记物患病率为4.50%以内0.27%。据报道,鉴于验证标记的存在,重大先天性异常,死产,前期出生和小于妊娠期的相对风险。讨论这是一个大型前瞻性研究,旨在估算孕妇群体中标记的普遍性,并调查与不良妊娠结果的关联。该研究还将建立一个可以随访的儿童队列,以探索具体标记和长期健康和社会成果之间的协会。

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