Diagnostic value of Chorioquick for detecting chorioamnionitis in women with premature rupture of membranes.

OBJECTIVE: To determine the accuracy of a semi-quantitative interleukin-6 (IL-6) vaginal secretion rapid test (Chorioquick) for detecting chorioamnionitis in women with premature rupture of membranes (PROM). METHODS: A prospective cohort study in five tertiary hospitals in Nigeria involved women with confirmed PROM at term and preterm PROM with or without suspected chorioamnionitis from August 1, 2017, to October 31, 2018. Cervicovaginal fluid samples were tested for chorioamnionitis using the Chorioquick test. Samples were repeated at decision to deliver. The test was considered positive if at least the indicator 'IL-6 low' of the three Chorioquick biomarkers (low, medium, high) was positive, or negative if none of the biomarkers were positive. Chorioamnionitis was histologically confirmed post-delivery using three tissue samples. Primary outcome measures were sensitivity, specificity, and accuracy. RESULTS: Of 73 women, on histological confirmation, 39 were true positive and 29 were true negative (for chorioamnionitis) to the Chorioquick test at repeat assessment. Overall, the Chorioquick test had a sensitivity of 97.5% (95% confidence interval [CI] 85.3-99.9), specificity 87.9% (70.9-96.0), and accuracy 93.2% (79.5-99.1). Sub-group analysis of women <37 weeks of pregnancy showed a sensitivity of 100.0% (95% CI 83.4-100.0), specificity of 91.3% (70.5-98.5), and accuracy of 95.8% (82.5-99.5). Triple positive samples were 100.0% specific in all gestations. CONCLUSION: Chorioquick showed favorable utility for detecting chorioamnionitis in PROM and could be a reliable, non-invasive rapid tool in a real-world clinical setting.

Performance indices of AmnioQuick Duo+ versus placental α-microglobulin-1 tests for women with prolonged premature rupture of membranes.

OBJECTIVE: To compare AmnioQuick Duo+ versus the placental α-microglobulin-1 (PAMG-1) test for diagnosis of prolonged premature rupture of membranes (PROM). METHODS: A multicenter prospective cohort study included women with suspected PROM at six tertiary institutions in southern Nigeria between January 1 and December 31, 2015. The inclusion criteria were features of PROM lasting at least 24 hours and a pregnancy duration of more than 24 weeks. AmnioQuick Duo+ (Biosynex, Strasbourg, France) and PAMG-1 (AmniSure International, Boston, USA) tests were used to diagnose PROM, which was confirmed after delivery by any two of the following criteria: delivery within 48 hours to 7 days, chorioamnionitis, membranes perceptibly ruptured at delivery, and adverse perinatal outcomes considerably associated with prolonged PROM. RESULTS: Of 100 women assessed for eligibility, 99 were included. Sensitivity, specificity, and accuracy were, respectively, 97.3%, 100%, and 95.9% for AmnioQuick Duo+, and 93.2%, 100%, and 90.4% for PAMG-1. The differences were not significant and the diagnostic discordant rate between the two tests was 3.1%. In equivocal cases (i.e., negative pooling test result), AmnioQuick Duo+ and PAMG-1 performed equally (diagnostic accuracy, 100% vs 97.7%; P>0.99). CONCLUSION: For diagnosis of PROM, AmnioQuick Duo+ was found to be non-inferior and comparable in accuracy to the PAMG-1 test, with a diagnostic discordance rate of 3.1%.

Premaquick© versus modified Bishop score for preinduction cervical assessment at term: A double-blind randomized trial.

AIM: To test whether Premaquick biomarkers were superior to modified Bishop score for preinduction cervical assessment at term. METHODS: A multicenter, double-blind randomized clinical trial in 151 nulliparous, cephalic presenting and singleton pregnancies was conducted. The cervix was considered 'ripe' when at least two out of three Premaquick biomarkers are positive or a Bishop score of ≥6. Main outcome measures were proportion of women who were administered or had additional prostaglandin E1 analogue (PGE1) as a preinduction agent and incidence of uterine rupture. The trial was registered in PACTR registry with approval number PACTR201604001592143. Analysis was performed by intention-to-treat principle. RESULTS: The need for initial PGE1 analogue (77.6% vs 98.7%, risk ratio [RR] =0.47, 95% confidence intervals [95% CI] =0.38-0.59, P < 0.001) and additional PGE1 analogue for cervical ripening after one insertion (44.7% vs 68.0%, RR = 0.63, 95% CI = 0.46-0.86, P = 0.004) was significantly lower in Premaquick group. There was no significant difference in incidence of uterine rupture (0% vs 1.4%, RR = 0.000, P = 0.324); however, the frequency of transition to labor was statistically higher in Premaquick group (44.7% vs 22.7%, RR = 1.59, 95% CI = 1.17-2.15, P = 0.004). Interval from start of induction to any type of delivery, need for oxytocin augmentation, vaginal delivery, number of women with cesarean section for failed induction and number of infants admitted to neonatal intensive care unit were similar between the two groups (P > 0.05). CONCLUSION: Preinduction cervical assessment with Premaquick was significantly associated with higher frequency of transition to labor and reduced need for PGE1 analogue when compared to modified Bishop score. Further similar trials in other settings are necessary to strengthen or refute this observation.