Development and validation of a spontaneous preterm delivery predictor in asymptomatic women

May 2016 This study, published as an Editor’s Choice article in the May issue of American Journal of Obstetrics & Gynecology, concluded that a serum-based molecular predictor (the PreTRM test) predicts an asymptomatic pregnant woman’s individual risk of spontaneous preterm delivery. This information, early in her pregnancy, may provide clinical utility in identifying women at increased risk at an early stage of pregnancy and allowing for clinical intervention that may help prolong gestational age and improve neonatal outcome.

Background:  Preterm delivery remains the leading cause of perinatal mortality. Risk factors and biomarkers have traditionally failed to identify the majority of preterm deliveries.

Study Design:  A total of 5501 pregnant women were enrolled between 17 0/7 and 28 6/7 weeks gestational age in the prospective Proteomic Assessment of Preterm Risk (PAPR) study at 11 sites in the United States between 2011 and 2013. Maternal blood was collected at enrollment and outcomes collected following delivery. Maternal serum was processed by a proteomic workflow, and proteins were quantified by multiple reaction monitoring mass spectrometry. The discovery and verification process identified 2 serum proteins, insulin-like growth factor-binding protein 4 (IBP4) and sex hormone-binding globulin (SHBG), as predictors of spontaneous preterm delivery.

Results:  The predictor had an area under the receiver operating characteristic curve value of 0.75 and sensitivity and specificity of 0.75 and 0.74, respectively. The IBP4/SHBG predictor at this sensitivity and specificity had an odds ratio of 5.04 for spontaneous preterm delivery.

Conclusion:  A serum-based molecular predictor identifies asymptomatic pregnant women at risk of spontaneous preterm delivery, which may provide utility in identifying women at risk at an early stage of pregnancy to allow for clinical intervention. This early detection would guide enhanced levels of care and accelerate development of clinical strategies to prevent preterm delivery.

Online AJOG Publication