Preterm premature rupture of membranes (PPROM) refers to rupture of fetal membranes prior to labor in pregnancies of less than 37 weeks. It occurs in 3 percent of pregnancies and is responsible for one-third of preterm births. The best method of confirming the diagnosis of PPROM is direct observation of amniotic fluid coming out of the cervical canal or pooling in the vaginal fornix. If PPROM is not obvious after visual inspection, the diagnosis can be confirmed by testing the pH of the vaginal fluid with nitrazine paper or looking for a ferning pattern in dried fluid. False negative and false positive test results occur in up to 5 percent of cases.

 Point of care immunochromatographic assays have been developed to improve diagnostic accuracy. AmniSure® was the first commercially available assay that detects trace amounts of placental alpha microglobulin-1 protein (PAMG-1) in vaginal fluid after rupture of fetal membranes.

 Recently, a new immunochromatographic assay, ROM Plus®, became available. ROM Plus® detects both placental protein 12 (PP12, aka IGFBP2) and alpha fetoprotein (AFP). PP12 is synthesized by the decidua of the placenta and reaches a very high concentration in amniotic fluid early in the first trimester. AFP is synthesized by the fetal liver and yolk sac and reaches its peak concentration late in the second or early in the third trimester. The use of 2 proteins increases the chance that the proteins will be detected in the pre-term patients

 A parallel study in our laboratory of RomPlus® and Amnisure® revealed equivalent performance. RomPlus® was easier to perform and had a much lower cost per test. 


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