Abstract: Compositions, kits and methods for diagnosing and treating an increased risk of preterm birth (PTB) involves a composition comprising at least one reagent capable of detecting, binding, specifically complexing with, or measuring the level of one of a subject bacterium in a sample. Optionally, a composition of the invention further comprises a reagent capable of detecting, binding, specifically complexing with, or measuring the expression of a subject biomarker.

Abstract: A method for diagnosing, or differentially diagnosing, an increased risk of pre-term birth (PTB) involves detecting or measuring increased expression of a biomarker Soluble E-cadherin (SE-CAD) in a biological sample from a mammalian subject, particularly in the urine, cervicovaginal fluid or blood. An increased level of expression of SE-CAD above the level of expression in the same sample of a healthy mammalian subject is an indication of a diagnosis of increased risk of PTB. Such diagnosis may further involve identify other clinical symptoms of PTB or PTL. Additionally the method may use additional biomarkers, such as fetal fibronectin.