Premature preterm rupture of the membrane diagnosis in early pregnancy: PAMG-1 and IGFBP-1 detection in amniotic fluid with biochemical tests

• Premature preterm rupture of membrane (pPROM) diagnosis may be difficult.
• We compared in vitro 2 biochemical tests for amniotic fluid detection before 20 WG.
• Biochemical tests were AmniSure detecting PAMG-1 and actim PROM detecting IGFBP-1.
• Amniotic fluid sample was collected during amniocentesis between 15 and 20 WG.
• Tests were sensitive and comparable to identify amniotic fluid in early pregnancy.

ObjectivesPreviable premature rupture of the membranes (pPROM), occurring before 24 WG, is associated with a 25% neonatal survival rate. This terrible prognosis may lead to elective pregnancy termination on parents' request. Therefore, certain diagnosis is essential but remains difficult in about 10% of patients. Bed-side biochemical tests developed to help in diagnosis had never been evaluated in early pregnancies. This study aimed to evaluate and compare the in vitro sensitivity, detection limit, reaction time and consistency of AmniSure detecting placental alpha microglobulin-1 (PAMG-1) and actim PROM detecting Insulin Growth Factor Binding Protein-1 (IGFBP-1) in amniotic fluid between 15 and 20 weeks of gestation (WG).Design and methodsSamples of amniotic fluid were collected by amniocentesis performed between 15 and 20 completed WG in 55 patients. Dilution series were prepared and both tests were performed twice at each dilution. In vitro sensitivity, detection limit, and reaction time were evaluated and compared in serial dilution.ResultsA total of 460 AmniSure and 476 actim PROM tests were performed. Both tests' in vitro sensitivity was 100% at dilution 1:20 and remained up to 90% until dilution 1:80. In vitro sensitivities were not different at any dilution. Detection limit and consistency were similar for both tests at all dilution. Actim PROM reaction time was shorter than AmniSure at all dilutions, except 1:320 (p < 0.05).ConclusionsPAMG-1 and IGFBP-1 can be detected in amniotic fluid between 15 and 20 completed WG, using respectively AmniSure and actim PROM.