Hellemans P, Verdonk P, Baekelandt M, Joostens M, Francx M, Gerris J
Department of Obstetrics, Gynecology and Reproductive Biology, General Hospital Middelheim, Antwerp, Belgium.
Eur J Obstet Gynecol Reprod Biol. 1992 Feb 28;43(3):173-9. doi: 10.1016/0028-2243(92)90170-4.
The unequivocal presence of amniotic fluid in the vagina is an important clinical sign of rupture of amniotic membranes, entailing impending delivery or risk for chorioamnionitis. Commonly used methods for detection of amniotic fluid in the vagina include pooling, ferning, nitrazine paper, ultrasound measurement of amniotic sac dimensions, dye injection or measurement of prolactin in vaginal secretions. These results are either difficult to interpret or are obtained after an invasive or expensive procedure. Measurement of alphafetoprotein (AFP) in vaginal secretions has also been considered for this application, but has proven unreliable due to its similar concentration in maternal plasma and amniotic fluid in the third trimester of pregnancy. We have evaluated a recently introduced method, the ROM-check Immunoassay (Adeza Biomedical, Sunnyvale, CA, USA) which is based on the detection of a fetal isoform of fibronectin in vaginal secretions when amniotic fluid is present. Our aim was to establish the reliability and clinical efficacy of this test in a number of obstetrical situations with unequivocal or equivocal rupture of the membranes (ROM). We conclude that in cases of unequivocal rupture and/or intactness of membranes, results of the ROM-check Immunoassay correspond well with the clinical findings, whereas in clinically equivocal rupture of the membranes, the test may add proof to the clinical suspicion of ROM but has to be interpreted with caution along with other clinical and non-clinical parameters.
阴道内明确存在羊水是胎膜破裂的一项重要临床体征，意味着即将分娩或有发生绒毛膜羊膜炎的风险。检测阴道内羊水的常用方法包括羊水积聚检查、羊齿状结晶检查、石蕊试纸检查、超声测量羊膜囊大小、染料注射或检测阴道分泌物中的催乳素。这些结果要么难以解读，要么是在进行侵入性或昂贵的检查后才能获得。阴道分泌物中甲胎蛋白（AFP）的检测也曾被考虑用于此用途，但由于其在妊娠晚期母体血浆和羊水中的浓度相似，已证明不可靠。我们评估了一种最近推出的方法，即胎膜早破检查免疫测定法（美国加利福尼亚州桑尼维尔市的Adeza Biomedical公司生产），该方法基于检测阴道分泌物中存在羊水时的一种胎儿纤连蛋白异构体。我们的目的是在一些胎膜明确或不明确破裂（ROM）的产科情况下确定该检测的可靠性和临床疗效。我们得出结论，在胎膜明确破裂和/或完整的情况下，胎膜早破检查免疫测定法的结果与临床发现相符，而在临床上胎膜破裂情况不明确时，该检测可能会为临床对胎膜早破的怀疑提供证据，但必须结合其他临床和非临床参数谨慎解读。
