University of California Irvine, Orange, California; St. David's Medical Center, Austin, Texas; Summa Health, Akron, Ohio; HonorHealth Scottsdale Shea Medical Center, Scottsdale, Arizona; the University of Kansas, Kansas City, Kansas; Meritus Health, Hagerstown, Maryland; South Shore Hospital, South Weymouth, Massachusetts; Promedica-The Toledo Hospital, Toledo, Ohio; St. Luke's Hospital of Kansas City, Kansas City, Missouri; the University at Buffalo-Women and Children's Hospital of Buffalo, Buffalo, New York; Stony Brook University School of Medicine, Stony Brook, New York; the University of California, Los Angeles, Los Angeles, California; the University of California San Diego, San Diego, California; the University of California, Davis, Sacramento, California; and the University of California, San Francisco, California.
Obstet Gynecol. 2017 Dec;130(6):1183-1191. doi: 10.1097/AOG.0000000000002367.
To compare the rapid bedside test for placental α microglobulin-1 with the instrumented fetal fibronectin test for prediction of imminent spontaneous preterm delivery among women with symptoms of preterm labor.
We conducted a prospective observational study on pregnant women with signs or symptoms suggestive of preterm labor between 24 and 35 weeks of gestation with intact membranes and cervical dilatation less than 3 cm. Participants were prospectively enrolled at 15 U.S. academic and community centers. Placental α microglobulin-1 samples did not require a speculum examination. Health care providers were blinded to placental α microglobulin-1 results. Fetal fibronectin samples were collected through speculum examination per manufacturer requirements and sent to a certified laboratory for testing using a cutoff of 50 ng/mL. The coprimary endpoints were positive predictive value (PPV) superiority and negative predictive value (NPV) noninferiority of placental α microglobulin-1 compared with fetal fibronectin for the prediction of spontaneous preterm birth within 7 days and within 14 days.
Of 796 women included in the study cohort, 711 (89.3%) had both placental α microglobulin-1 and fetal fibronectin results and valid delivery outcomes available for analysis. The overall rate of preterm birth was 2.4% (17/711) within 7 days of testing and 4.2% (30/711) within 14 days of testing with respective rates of spontaneous preterm birth of 1.3% (9/703) and 2.9% (20/701). Fetal fibronectin was detected in 15.5% (110/711), and placental α microglobulin-1 was detected in 2.4% (17/711). The PPVs for spontaneous preterm delivery within 7 days or less among singleton gestations (n=13) for placental α microglobulin-1 and fetal fibronectin were 23.1% (3/13) and 4.3% (4/94), respectively (P<.025 for superiority). The NPVs were 99.5% (619/622) and 99.6% (539/541) for placental α microglobulin-1 and fetal fibronectin, respectively (P<.001 for noninferiority).
Although placental α microglobulin-1 performed the same as fetal fibronectin in ruling out spontaneous preterm delivery among symptomatic women, it demonstrated statistical superiority in predicting it.
比较胎盘α微球蛋白-1的快速床边检测与纤维连接蛋白检测在预测有早产症状的孕妇即将发生自发性早产中的作用。
我们对 15 个美国学术和社区中心的 24 至 35 周有完整胎膜和宫颈扩张小于 3 厘米的早产症状孕妇进行了前瞻性观察性研究。前瞻性纳入的参与者。胎盘α微球蛋白-1 样本不需要阴道镜检查。医护人员对胎盘α微球蛋白-1 结果不知情。胎儿纤维连接蛋白样本通过阴道镜检查按制造商要求采集，并送至认证实验室，使用 50ng/mL 的截止值进行检测。主要终点是胎盘α微球蛋白-1预测 7 天内和 14 天内自发性早产的阳性预测值（PPV）优越性和阴性预测值（NPV）非劣效性与胎儿纤维连接蛋白比较。
在研究队列的 796 名女性中，711 名（89.3%）有胎盘α微球蛋白-1和胎儿纤维连接蛋白的结果以及有效的分娩结局可供分析。检测后 7 天内早产总体发生率为 2.4%（17/711），检测后 14 天内早产发生率为 4.2%（30/711），自发性早产率分别为 1.3%（9/703）和 2.9%（20/701）。711 例中，15.5%（110/711）检测到胎儿纤维连接蛋白，2.4%（17/711）检测到胎盘α微球蛋白-1。胎盘α微球蛋白-1和胎儿纤维连接蛋白预测单胎妊娠 7 天内自发性早产的 PPV 分别为 23.1%（13/56）和 4.3%（9/210）（P<.025 为优效性）。NPV 分别为 99.5%（619/622）和 99.6%（539/541）（P<.001 为非劣效性）。
虽然胎盘α微球蛋白-1在排除有症状的孕妇自发性早产方面与胎儿纤维连接蛋白一样，但在预测早产方面表现出统计学上的优势。
