Multicenter prospective clinical study to evaluate the prediction of short-term outcome in pregnant women with suspected preeclampsia (PROGNOSIS): study protocol
Multicenter prospective clinical study to evaluate the prediction of short-term outcome in pregnant women with suspected preeclampsia (PROGNOSIS): study protocol
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DOI：
10.1186/1471-2393-14-324
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发表时间：
2014-09-18
影响因子：
3.1
通讯作者：
Stepan, Holger
中科院分区：
文献类型：
--
作者：
Hund, Martin;Allegranza, Deirdre;Stepan, Holger
背景：子痫前期被定义为妊娠20周或之后新发的高血压和蛋白尿。然而，在临床发病前使用这些方法预测子痫前期是不可靠的，有证据表明，子痫前期、子痫或溶血、肝酶升高和低血小板计数（HELLP）综合征可能在没有明显高血压或蛋白尿的情况下发生。由于其不可预测性、不同的临床表现和潜在的不良后果，怀疑子痫前期的孕妇需要加强监测或住院治疗。除了子痫前期诊断之外，对更可靠的子痫前期预测标志物的医学需求尚未得到满足，以改善母婴结局并减少不必要的住院。在诊断为子痫前期和临床发病前的妇女中发现循环血管生成和抗血管生成因子失衡，包括可溶性纤维样酪氨酸激酶-1 （sFlt-1）升高和胎盘生长因子（PlGF）降低。预测疑似子痫前期妊娠妇女的短期预后研究（PROGNOSIS）旨在研究sFlt-1/PlGF比值在短期预测子痫前期的应用。方法/设计：这项全球性、多中心、前瞻性、双盲、非干预性研究旨在推导和验证sFlt-1/PlGF比率的截止值，以排除（1周内）或限制（4周内）子痫前期/子痫/HELLP综合征的发生。合格的参与者是24岁至
Background: Preeclampsia is defined as new onset of hypertension and proteinuria at gestational week 20 or after. However, use of these measures to predict preeclampsia before its clinical onset is unreliable, and evidence suggests that preeclampsia, eclampsia, or hemolysis, elevated liver enzymes and low platelet count (HELLP) syndrome may develop without hypertension or proteinuria being evident. Because of its unpredictability, varying clinical presentation and potential adverse outcomes, pregnant women with suspected preeclampsia require intensive monitoring or hospitalization. Beyond preeclampsia diagnosis, there is a high unmet medical need for more reliable predictive markers for preeclampsia to improve maternal and fetal outcomes and reduce unnecessary hospital admissions. An imbalance of circulating angiogenic and antiangiogenic factors, including raised soluble fms-like tyrosine kinase-1 (sFlt-1) and decreased placental growth factor (PlGF), has been found in women diagnosed with preeclampsia and before clinical onset of the disease. The PRediction of short-term Outcome in preGNant wOmen with Suspected preeclampsla Study (PROGNOSIS) was designed to investigate the use of the sFlt-1/PlGF ratio in the short-term prediction of preeclampsia.Methods/Design: This global, multicenter, prospective, double-blind, non-interventional study aims to derive and validate cutoffs for the sFlt-1/PlGF ratio, to rule out (for 1 week) or rule in (within 4 weeks) the occurrence of preeclampsia/eclampsia/HELLP syndrome. Eligible participants are women presenting at 24 to