Evaluation of a novel placental alpha microglobulin-1 (PAMG-1) test to predict spontaneous preterm delivery

J Perinat Med. 2014 Jul;42(4):473-7. doi: 10.1515/jpm-2013-0234.

Abstract

Objective: The PartoSure time-to-delivery (TTD) test (AmniSure International, Boston, MA, USA) is a newly available bedside test for the prediction of time to spontaneous preterm delivery via the detection of placental alpha microglobulin-1. The objective of this study was to determine the efficacy of the test in predicting imminent delivery in 7 or 14 days from the time of testing.

Methods: The study population consisted of 101 consecutively recruited pregnant women with singleton pregnancies between 20+0 and 36+6 weeks of gestation with symptoms of preterm labor, clinically intact amniotic membranes, and minimal cervical dilatation (≤3 cm). The PartoSure TTD test was performed on these patients and the test-to-spontaneous-delivery interval was calculated.

Results: The PartoSure TTD test predicted spontaneous preterm delivery within 7 days with 90.0% sensitivity, 93.8% specificity, 97.4% negative predictive value (NPV), and 78.3% positive predictive value (PPV). The test predicted spontaneous preterm delivery within 14 days with 80% sensitivity, 96.1% specificity, 93.6% NPV, and 87.0% PPV.

Conclusion: A positive PartoSure TTD test in patients presenting with symptoms of preterm labor, intact membranes, and minimal cervical dilatation (≤3 cm) indicated spontaneous preterm delivery will occur within 7 days with a high degree of accuracy. A negative result indicated that spontaneous preterm delivery within 14 days is highly unlikely.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Alpha-Globulins / analysis*
  • Biomarkers / analysis*
  • Cervix Uteri
  • Female
  • Gestational Age
  • Humans
  • Obstetric Labor, Premature
  • Placenta / chemistry*
  • Pregnancy
  • Premature Birth / diagnosis*
  • Prospective Studies
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Time Factors
  • Young Adult

Substances

  • Alpha-Globulins
  • Biomarkers
  • Reagent Kits, Diagnostic
  • alpha-1-microglobulin