Rupture of fetal membranes that occurs before the onset of labor is known as Premature Rupture of Membranes (PROM). PROM occurs relatively frequent and concerns 5 to 10% of pregnancy cases. It might lead to fetal infection and preterm delivery. Appropriate management of PROM is important to reduce the consequences to neonatal health. The leakage of amniotic liquid is not always detectable by conventional clinical examination and therefore a confirmatory biological test can be very useful. Biological tests are based on detection of alkalinisation of vaginal fluid (easy to proceed, sensitive and inexpensive, but poorly specific) or presence of a molecule which is physiologically present in high concentration in amniotic fluid such as insulin-like growth factor binding protein-1 (IGFBP-1).

IGFBP-1, also known as placental protein 12 (PP12), is the major insulin-like growth factor binding protein in the amniotic fluid, which gradually increases in the second trimester and remains higher throughout pregnancy in comparison to its plasma levels. Its concentration in amniotic fluid is 100–1000 times higher than the concentration in other bodily fluids. IGFBP-1 phosphorylated isoform is mainly secreted in the decidua cells and human liver, whereas the non-phosphorylated isoform is mainly found in the amniotic fluid. Detection of IGFBP-1 in the cervical–vaginal secretions has been shown to be a reliable method in the diagnosis of ruptured amniotic membrane in cases in which the clinical diagnosis is uncertain.

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