The diagnosis of rupture of fetal membranes (ROM): a meta-analysis

Abstract

Aim: The aim of this study was to compare the performance of tests based on the detection of insulin-like growth factor binding protein 1 (IGFBP-1) and placental α -microglobulin-1 (PAMG-1) in diagnosing rupture of fetal membranes (ROM) across different patient populations. Methods: A meta-analysis was conducted on prospective observational or cohort studies investigating ROM tests based on the detection of IGFBP-1 and PAMG-1 meeting the following criteria: (1) performance metrics calculated by comparing results to an adequate reference method; (2) sensitivity thresholds of the investigated tests matching those of the currently available tests; (3) study population, as a minimum, included patients between 25 and 37 weeks of gestation. Sensitivities, specificities, and diagnostic odds ratios were calculated. Results: Across all patient populations, the analyzed performance measures of the PAMG-1 test were significantly superior compared with those of the IGFBP-1 test. Of particular clinical relevance, PAMG-1 outperformed IGFBP-1 in the equivocal group, which comprised patients with uncertain rupture of membranes (sensitivity, 96.0 % vs. 73.9 % ; specificity, 98.9 % vs. 77.8 % ; respectively). Conclusions: Compared with its performance in women with known membrane status, the accuracy of the IGFBP-1 test decreases significantly when used on patients whose membrane status is unknown. In this latter clinically relevant population, the PAMG-1 test has higher accuracy than the IGFBP-1 test.

Quantitative Measurement of Beta Subunit of ‎human Chorionic Gonadotrphin in Vaginal ‎washing and Its Role in Diagnosis of Premature ‎rupture of Membranes.

“…Direct visualization of liquor passage through the external cervical os during speculum examination is definitive, but this is not possible in every case. Thus, many tests has been advised for diagnosis of PROM, however, each one has its own limitations, making the diagnosis of PROM difficult (Ramsauer et al, 2013).…”

“…PROM has a considerable incidence rate, and is responsible for serious morbidities and mortalities to both the mother and her fetus. Based on these findings, premature rupture of membranes has been the scope of many studies, but its diagnosis remains a dilemma (Ramsauer et al, 2013).…”

Placental alpha-microglobulin-1 and combined traditional diagnostic test: a cost-benefit analysis

“…These findings are clinically relevant to practice because the greatest economic value of PAMG-1 will be derived from nonobvious or inconclusive cases. 10,12,18 We acknowledge that there are several limitations of our study. Instead of determining cost-effectiveness with cost and clinical outcomes or cost and quality-adjusted life years, we purely focused on cost and cost comparison.…”

“…21 Literature has shown that PAMG-1 is highly accurate in diagnosing ROM with superior test characteristics. 7,8,[15][16][17][18][19] It is imperative to note that in most publications evaluating CTDT, the abovereported sensitivity was calculated using specimens from laboring subjects in which there was certainty about the diagnosis of ROM. 36 For example, the sensitivity for the fern test was 51% and 98% in nonlaboring and laboring patients, respectively.…”

“…[10][11][12][13][14] Because of these limitations, placental alpha-microglobulin (PAMG)-1 has emerged as a highly accurate biomarker in the diagnosis of rupture of membrane (ROM). 7,8,[15][16][17][18][19] The widespread use and clinical effectiveness of the PAMG-1 assay 6 was formally recognized by the authors of the Guidelines for the Management of Spontaneous Preterm Labor. 20 However, there remains a dearth of literature that evaluates the economic aspects of adopting this technology in testing for PPROM.…”