Nikolova Tanja, Bayev Oleg, Nikolova Natasha, Di Renzo Gian Carlo
J Perinat Med. 2014 Jul;42(4):473-7. doi: 10.1515/jpm-2013-0234.
The PartoSure time-to-delivery (TTD) test (AmniSure International, Boston, MA, USA) is a newly available bedside test for the prediction of time to spontaneous preterm delivery via the detection of placental alpha microglobulin-1. The objective of this study was to determine the efficacy of the test in predicting imminent delivery in 7 or 14 days from the time of testing.
The study population consisted of 101 consecutively recruited pregnant women with singleton pregnancies between 20+0 and 36+6 weeks of gestation with symptoms of preterm labor, clinically intact amniotic membranes, and minimal cervical dilatation (≤3 cm). The PartoSure TTD test was performed on these patients and the test-to-spontaneous-delivery interval was calculated.
The PartoSure TTD test predicted spontaneous preterm delivery within 7 days with 90.0% sensitivity, 93.8% specificity, 97.4% negative predictive value (NPV), and 78.3% positive predictive value (PPV). The test predicted spontaneous preterm delivery within 14 days with 80% sensitivity, 96.1% specificity, 93.6% NPV, and 87.0% PPV.
A positive PartoSure TTD test in patients presenting with symptoms of preterm labor, intact membranes, and minimal cervical dilatation (≤3 cm) indicated spontaneous preterm delivery will occur within 7 days with a high degree of accuracy. A negative result indicated that spontaneous preterm delivery within 14 days is highly unlikely.
PartoSure分娩时间(TTD)检测(美国马萨诸塞州波士顿市的AmniSure International公司)是一种新的床旁检测,通过检测胎盘α微球蛋白-1来预测自然早产的时间。本研究的目的是确定该检测在预测从检测时起7天或14天内即将分娩的有效性。
研究人群包括101例连续招募的单胎妊娠孕妇,妊娠周数在20 + 0至36 + 6周之间,有早产症状,胎膜临床完整,宫颈扩张最小(≤3 cm)。对这些患者进行PartoSure TTD检测,并计算检测至自然分娩的间隔时间。
PartoSure TTD检测预测7天内自然早产的灵敏度为90.0%,特异度为93.8%,阴性预测值(NPV)为97.4%,阳性预测值(PPV)为78.3%。该检测预测14天内自然早产的灵敏度为80%,特异度为96.1%,NPV为93.6%,PPV为87.0%。
对于出现早产症状、胎膜完整且宫颈扩张最小(≤3 cm)的患者,PartoSure TTD检测呈阳性表明自然早产将在7天内发生,准确性较高。阴性结果表明14天内自然早产极不可能。