Cervical phosphorylated insulin-like growth factor binding protein-1 test for the prediction of preterm birth: a systematic review and metaanalysis

Abstract

OBJECTIVE To assess the accuracy of the cervical phosphorylated insulin-like growth factor binding protein-1 (phIGFBP-1) test to predict preterm birth in women with and without symptoms of preterm labor through use of formal methods for systematic reviews and meta-analytic techniques. DATA SOURCES PubMed, Embase, Cinahl, Lilacs, and Medion (all from inception to June 20, 2015), reference lists, conference proceedings, and Google scholar. STUDY ELIGIBILITY CRITERIA Cohort or cross-sectional studies that reported on the predictive accuracy of cervical phIGFBP-1 test for preterm birth. STUDY APPRAISAL AND SYNTHESIS METHODS Two reviewers independently selected studies, assessed risk of bias, and extracted data. Summary receiver operating characteristic curves, pooled sensitivities and specificities, and summary likelihood ratios were generated. RESULTS Forty-three studies met the inclusion criteria of which 15 provided data on asymptomatic women (n=6583) and 34 on women with an episode of preterm labor (N=3620). Among asymptomatic women, the predictive accuracy of cervical phIGFBP-1 test for preterm birth at <37, <34 and <32 weeks of gestation was minimal with pooled sensitivities and specificities, and summary positive and negative likelihood ratios ranging from 14-47%, 76-93%, 1.5-4.4, and 0.6-1.0, respectively. Among women with an episode of preterm labor, the test had a low predictive performance for delivery within 7 and 14 days of testing, and preterm birth at <34 and <37 weeks of gestation with pooled sensitivities and specificities, and summary positive and negative likelihood ratios that varied between 60 and 68%, 77 and 81%, 2.7 and 3.5, and 0.4 and 0.5, respectively. A negative test result in women with an episode of preterm labor had a low to moderate accuracy to identify women who are not at risk for delivering within the next 48 hours (summary negative likelihood ratio of 0.28 in all women and 0.23 in women with singleton gestations). CONCLUSION Cervical phIGFBP-1 has potential utility to identify patients with an episode of preterm labor who will not deliver within 48 hours. However, its overall predictive ability for the identification of symptomatic and asymptomatic women at risk for preterm birth is limited.

Comparison of PAMG-1 and phIGFBP-1 Tests for the Prediction of Preterm Delivery in Patients with Preterm Labor

“…The present investigation could have benefited from the addition of a cost analysis to determine the financial impact of different treatment modalities and admission rates based on the contingent results of biochemical tests after ultrasound. A recent systematic review and meta-analysis conducted by Conde-Agudelo et al on the phIGFBP-1 test, which reviewed 18 independent studies reporting the performance of phIGFBP-1 for predicting imminent spontaneous preterm birth within 7 days of presentation, concluded that there was insufficient evidence to recommend the routine clinical use of the phIGFBP-1 test in women with symptoms of preterm labor [22].…”

Good clinical practice advice: Prediction of preterm labor and preterm premature rupture of membranes

“…An immunochromatography‐based dipstick test is used to obtain the result within 5 minutes. The test reported pooled sensitivity and specificity in some studies . Among women with a singleton gestation and 30 mm cervical length, a positive cervical phIGFBP‐1 test (summary likelihood ratio of 5.5) increased the pretest probability of delivery within 7 days of testing from 17.8% to 54.4%, whereas a negative test result (summary likelihood ratio of 0.3) decreased the risk to 6.1%.…”

“…phIGFBP-1 is produced by the placental decidual cells and thought to be released into the cervical vaginal fluid after tissue damage to the choriodecidual interface. 24 A qualitative test, either positive or negative, is measured from a vaginal swab taken with a speculum between 22 and 36 weeks of gestation. An immunochromatographybased dipstick test is used to obtain the result within 5 minutes.…”

An elevated amniotic fluid prostaglandin F2αconcentration is associated with intra-amniotic inflammation/infection, and clinical and histologic chorioamnionitis, as well as impending preterm delivery in patients with preterm labor and intact membranes

“…admission to the hospital, administration of steroids, transfer to a tertiary care center, etc.). This has been the basis for the evaluation of cervical length [42–56], fetal fibronectin [57–75], alpha-macroglobulin-1 [76–79], insulin-like growth factor binding protein-1 [80–89], and the concentration of inflammatory mediators in the amniotic fluid [90–116] and cervicovaginal fluid [88, 108, 117–126] in patients presenting with increased uterine contractility or suspected preterm labor.…”