Department of Obstetrics and Gynecology, Ain Shams University, Abbassia, Cairo, Egypt.
Arch Gynecol Obstet. 2013 Feb;287(2):205-10. doi: 10.1007/s00404-012-2548-3. Epub 2012 Sep 12.
This study was designed to detect the accuracy of the fetal fibronectin (Quick Check fFN test(®)) in diagnosing premature rupture of fetal membranes.
This comparative prospective study was carried out over 1 year in Ahmadi Kuwait Oil Company (KOC) Hospital, Kuwait from March 2011 till March 2012.
Two hundred and twenty (220) pregnant women >34 and <37 weeks gestation were included in this study and divided into two groups according to presence or absence of PROM; 110 patients with PROM were included in group I, and 110 patients without PROM were included in group II as controls. Patients with multiple pregnancies or >37 weeks gestation or not sure of dates or fetal distress or vaginal bleeding or preterm labor or chorioamnionitis were excluded from this study. The diagnosis of PROM was based on patient's history of sudden gush of water, pooling of amniotic fluid, positive ferning pattern, positive nitrazine test, confirmed by visualization of fluid passing from the cervical canal during sterile speculum examination and Trans-abdominal ultrasound to measure the amniotic fluid index (AFI ≤ 5 cm in PROM). The gestational age was calculate from the first day of LMP and confirmed by early ultrasound scan (done before 20 weeks gestation). Patients included in this study were subjected to standard examination, trans-abdominal ultrasound and sterile speculum examination to detect amniotic fluid pooling through the cervical canal and for collection of samples on admission. Some laboratory investigations were done to exclude chorioamnionitis (maternal fever, maternal tachycardia, fetal tachycardia, maternal leucocytosis, CRP).
In this study, the sensitivity and the specificity of fetal fibronectin in diagnosing PROM were 94.5 and 89.1 %, respectively, as compared with 84.5 % sensitivity and 78.2 % specificity for Ferning test, respectively, and 87.3 % sensitivity and 80.9 % specificity for Nitrazine test, respectively. The PPV and NPV of fetal fibronectin were 89.7 and 94.2 %, respectively, as compared with 79.5 % PPV and 83.5 % NPV for Ferning test, respectively, and 82.1 % PPV and 86.4 % NPV for Nitrazine test, respectively. Fetal fibronectin was more accurate (91.8 %) for detection of PROM than Ferning (81.4 %) or Nitrazine (84.1 %) tests.
The Quick Check fFN test(®) for detection of the fetal fibronectin in the vaginal fluid is a simple bedside test, more sensitive, and specific than Ferning and Nitrazine tests, it can be used as complimentary test to confirm the clinical diagnosis of premature rupture of fetal membranes.
本研究旨在检测胎儿纤维连接蛋白(Quick Check fFN 检测)在诊断胎膜早破中的准确性。
本研究为前瞻性对比研究,于 2011 年 3 月至 2012 年 3 月在科威特阿美石油公司(KOC)医院进行,共纳入 220 名孕周大于 34 周且小于 37 周的孕妇。根据是否存在胎膜早破将这些孕妇分为两组;110 例胎膜早破患者纳入组 I,110 例无胎膜早破患者纳入组 II 作为对照组。本研究排除多胎妊娠、孕周大于 37 周、无法确定预产期、胎儿窘迫、阴道出血、早产或绒毛膜羊膜炎的患者。胎膜早破的诊断基于患者突然大量羊水涌出、羊水积聚、阳性结晶试验、阳性硝嗪试验,以及在无菌窥器检查期间观察到液体从宫颈管流出,并通过经腹部超声测量羊水指数(胎膜早破时羊水指数≤5cm)得到证实。孕龄根据末次月经第一天计算,并通过早期超声扫描(在 20 周前进行)确认。本研究纳入的患者均接受标准检查、经腹部超声和无菌窥器检查,以检测宫颈管内羊水积聚,并在入院时采集样本。进行一些实验室检查以排除绒毛膜羊膜炎(产妇发热、心动过速、胎儿心动过速、产妇白细胞增多、CRP)。
在本研究中,与 Ferning 试验的 84.5%敏感性和 78.2%特异性相比,胎儿纤维连接蛋白在诊断胎膜早破方面的敏感性和特异性分别为 94.5%和 89.1%;与 Nitrazine 试验的 87.3%敏感性和 80.9%特异性相比,胎儿纤维连接蛋白的阳性预测值和阴性预测值分别为 89.7%和 94.2%。与 Ferning 试验的 79.5%阳性预测值和 83.5%阴性预测值相比,胎儿纤维连接蛋白对胎膜早破的检测更准确(91.8%)。
Quick Check fFN 检测用于检测阴道液中的胎儿纤维连接蛋白是一种简单的床边检测,比 Ferning 和 Nitrazine 试验更敏感、更特异,可作为胎膜早破临床诊断的辅助检测。