Rutanen E M, Kärkkäinen T H, Lehtovirta J, Uotila J T, Hinkula M K, Hartikainen A L
Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, Finland.
Clin Chim Acta. 1996 Sep 30;253(1-2):91-101. doi: 10.1016/0009-8981(96)80001-e.
We evaluated the clinical usefulness of a new bedside test (PROM TEST) for insulin-like growth factor binding protein-1 (IGFBP-1) in the detection of ruptured fetal membranes (ROM). Cervicovaginal secretion was sampled between 15 and 37 weeks of gestation from asymptomatic women with apparently intact membranes and from women with clinically confirmed ROM, as well as from symptomatic women with suspected ROM based on history. IGFBP-1 in samples was detected with a dipstick based on immunochromatography. The test result was positive in 100% of cases with unequivocal ROM and in 5.3% of cases with apparently intact membranes. Furthermore, the PROM TEST was positive in 64 of 181 patients evaluated for suspected ROM based on history, but in whom the diagnosis could not be clinically confirmed at the initial evaluation. Fifty of the 64 women (78.1%) were delivered prematurely (< 37 weeks). Five of the 117 PROM-negative patients had elective cesarean section for reasons unrelated to ROM before 37 weeks and 10 of the remaining 112 patients (8.9%) had preterm delivery. Women with equivocal ROM and a positive test result had a 6.9-fold increased relative risk (95% confidence interval 4.2-11.4) of preterm delivery compared with women who had a negative result at the time of evaluation. Multiple logistic regression including PROM TEST result, contractions, vaginal bleeding and cervical changes indicated that a positive PROM TEST result was an independent predictor of preterm delivery (P = 0.0001). In summary, a positive PROM TEST result identifies ROM with high sensitivity and a negative result effectively excludes those with intact membranes. In patients with suspected but clinically unconfirmed ROM, the positive test result is associated with increased risk of preterm delivery, suggesting that microruptures of fetal membranes can also be detected by the PROM TEST.
我们评估了一种用于检测胎膜破裂（ROM）的新型床旁检测方法（PROM检测）对胰岛素样生长因子结合蛋白-1（IGFBP-1）检测的临床实用性。在妊娠15至37周期间，对胎膜明显完整的无症状女性、临床确诊为ROM的女性以及根据病史怀疑有ROM的有症状女性采集宫颈阴道分泌物样本。使用基于免疫层析的试纸条检测样本中的IGFBP-1。在明确诊断为ROM的所有病例中，该检测结果均为阳性，而在胎膜明显完整的病例中，阳性率为5.3%。此外，在181例因病史怀疑有ROM但初始评估时临床无法确诊的患者中，PROM检测有64例呈阳性。这64名女性中有50名（78.1%）早产（<37周）。117例PROM检测阴性的患者中有5例因与ROM无关的原因在37周前进行了择期剖宫产，其余112例患者中有10例（8.9%）早产。与评估时结果为阴性的女性相比，ROM不明确但检测结果为阳性的女性早产的相对风险增加了6.9倍（95%置信区间4.2 - 11.4）。包括PROM检测结果、宫缩、阴道出血和宫颈变化的多因素logistic回归分析表明，PROM检测结果阳性是早产的独立预测因素（P = 0.0001）。总之，PROM检测结果阳性能以高灵敏度识别ROM，阴性结果能有效排除胎膜完整者。在怀疑有ROM但临床未确诊的患者中，检测结果阳性与早产风险增加相关，这表明PROM检测也能检测出胎膜微小破裂。
