Abstract：
UNASSIGNED: Tests capable of accurate prediction of spontaneous preterm birth (sPTB) are crucial to inform clinical decisions to prevent neonatal deaths and reduce the risk of morbidity in surviving infants. A systematic literature review and meta-analysis were performed to assess the utility of the quantitative fetal fibronectin (fFN) test to predict sPTB at different test concentration thresholds.
UNASSIGNED: Literature searches were conducted in MEDLINE, Embase, and the Cochrane Library in May 2022. Observational studies and clinical trials investigating the clinical utility of the quantitative fFN test in asymptomatic pregnancies prior to 37 weeks of gestation were eligible for inclusion. Meta-analysis quantified the risk of sPTB prior to four gestational age milestones (<28, <30, <34 and <37 weeks) based on quantitative fFN levels. No risk of bias assessment was performed however, clinical and methodological heterogeneity was explored to determine the feasibility of performing analyses.
UNASSIGNED: 11 studies showed a quantitative assessment of fFN can differentiate between very high and very low risks of sPTB in asymptomatic pregnancies with <10% of women with very low fFN (<10 ng/mL) versus 37-67% of women with very high fFN (>200 ng/mL) delivering before 34 weeks. A meta-analysis of two studies showed, albeit with a low number of events, the odds of sPTB prior to 28 weeks was nine times higher in women testing positive at ≥50 ng/mL, whereas the odds of sPTB was 25 times higher in women with fFN concentrations >200 ng/mL (versus <50 ng/mL reference). Similarly, pooling three studies showed the odds of sPTB prior to 37 weeks was four times higher in women who tested positive at ≥50 ng/ml whereas the odds of delivery before 37 weeks was seven times higher for women with fFN concentrations ≥200 ng/ml (versus <50 ng/mL reference).
UNASSIGNED: Quantitative fFN testing demonstrates increased predictive capabilities and utility of fFN testing in clinical practice, potentially preventing unnecessary intervention for women at very low risk and allowing an opportunity to optimize the management of asymptomatic patients at high risk of preterm delivery.
UNASSIGNED: Literature searches were conducted in MEDLINE, Embase, and the Cochrane Library in May 2022. Observational studies and clinical trials investigating the clinical utility of the quantitative fFN test in asymptomatic pregnancies prior to 37 weeks of gestation were eligible for inclusion. Meta-analysis quantified the risk of sPTB prior to four gestational age milestones (<28, <30, <34 and <37 weeks) based on quantitative fFN levels. No risk of bias assessment was performed however, clinical and methodological heterogeneity was explored to determine the feasibility of performing analyses.
UNASSIGNED: 11 studies showed a quantitative assessment of fFN can differentiate between very high and very low risks of sPTB in asymptomatic pregnancies with <10% of women with very low fFN (<10 ng/mL) versus 37-67% of women with very high fFN (>200 ng/mL) delivering before 34 weeks. A meta-analysis of two studies showed, albeit with a low number of events, the odds of sPTB prior to 28 weeks was nine times higher in women testing positive at ≥50 ng/mL, whereas the odds of sPTB was 25 times higher in women with fFN concentrations >200 ng/mL (versus <50 ng/mL reference). Similarly, pooling three studies showed the odds of sPTB prior to 37 weeks was four times higher in women who tested positive at ≥50 ng/ml whereas the odds of delivery before 37 weeks was seven times higher for women with fFN concentrations ≥200 ng/ml (versus <50 ng/mL reference).
UNASSIGNED: Quantitative fFN testing demonstrates increased predictive capabilities and utility of fFN testing in clinical practice, potentially preventing unnecessary intervention for women at very low risk and allowing an opportunity to optimize the management of asymptomatic patients at high risk of preterm delivery.
摘要：
■能够准确预测自发性早产（sPTB）的测试对于指导临床决策以预防新生儿死亡和降低存活婴儿的发病风险至关重要。进行了系统的文献综述和荟萃分析，以评估定量胎儿纤连蛋白（fFN）测试在不同测试浓度阈值下预测sPTB的实用性。
■文献检索在MEDLINE进行，Embase,和2022年5月的Cochrane图书馆。研究在妊娠37周之前的无症状妊娠中定量fFN测试的临床效用的观察性研究和临床试验符合纳入条件。荟萃分析根据定量fFN水平量化了四个胎龄里程碑（<28，<30，<34和<37周）之前的sPTB风险。然而，没有进行偏见风险评估，研究了临床和方法学异质性,以确定进行分析的可行性.
■11项研究表明，在无症状妊娠中，fFN的定量评估可以区分sPTB的极高和极低风险，其中<10％的妇女fFN非常低（<10ng/mL），而在34周分娩前，fFN非常高（>200ng/mL）的妇女为37-67％。两项研究的荟萃分析显示，尽管事件数量很少，在≥50ng/mL时呈阳性的女性中，28周前发生sPTB的几率高出9倍，而fFN浓度>200ng/mL的女性发生sPTB的几率高出25倍(相对于<50ng/mL参考).同样，汇总3项研究显示,在≥50ng/ml检测呈阳性的女性中,37周前发生sPTB的几率高出4倍,而在fFN浓度≥200ng/ml的女性中,37周前发生sPTB的几率高出7倍(相对于<50ng/mL参考).
■定量fFN测试证明了fFN测试在临床实践中的预测能力和实用性增强，有可能预防对极低风险妇女进行不必要的干预，并有机会优化早产高危无症状患者的管理。
■文献检索在MEDLINE进行，Embase,和2022年5月的Cochrane图书馆。研究在妊娠37周之前的无症状妊娠中定量fFN测试的临床效用的观察性研究和临床试验符合纳入条件。荟萃分析根据定量fFN水平量化了四个胎龄里程碑（<28，<30，<34和<37周）之前的sPTB风险。然而，没有进行偏见风险评估，研究了临床和方法学异质性,以确定进行分析的可行性.
■11项研究表明，在无症状妊娠中，fFN的定量评估可以区分sPTB的极高和极低风险，其中<10％的妇女fFN非常低（<10ng/mL），而在34周分娩前，fFN非常高（>200ng/mL）的妇女为37-67％。两项研究的荟萃分析显示，尽管事件数量很少，在≥50ng/mL时呈阳性的女性中，28周前发生sPTB的几率高出9倍，而fFN浓度>200ng/mL的女性发生sPTB的几率高出25倍(相对于<50ng/mL参考).同样，汇总3项研究显示,在≥50ng/ml检测呈阳性的女性中,37周前发生sPTB的几率高出4倍,而在fFN浓度≥200ng/ml的女性中,37周前发生sPTB的几率高出7倍(相对于<50ng/mL参考).
■定量fFN测试证明了fFN测试在临床实践中的预测能力和实用性增强，有可能预防对极低风险妇女进行不必要的干预，并有机会优化早产高危无症状患者的管理。
