Some embodiments relate to a method of determining a risk of preterm labour in a subject. The method includes: a) providing a sample from the subject, wherein the sample includes one or more of cervicovaginal fluid, endocervical fluid, foetal membrane fluid, amniotic fluid, serum or plasma b) measuring the elafin concentration in said sample and c) comparing the elafin concentration of (b) to a reference standard wherein if the elafin concentration of (b) is elevated compared to the reference standard, then it is indicated that said subject has an increased likelihood of preterm labour. Some embodiments also relate to combination methods and certain kits.
