Non-Invasive Testing for PROM and pPROM

Complications of premature rupture of the fetal membrane (PROM) can include infection, umbilical prolapse, placental abruption and preterm delivery. Preterm PROM (PROM occurring before 37 weeks’ gestation, abbreviated pPROM), is thought to be a factor in between 18-20% of all perinatal deaths. 1

Accurate diagnoses and early interventions are essential to the management of PROM. Unfortunately, there have been few practical options for testing for the condition until recent years.

Why Non-Invasive Testing Is Important

Currently, the majority of PROM and pPROM diagnoses are given following a sterile speculum exam in which the presence of amniotic fluid pooling from the cervical os is observed. For the 47% of PROM cases in which no visible symptoms are present,2 this alone is not sufficient. A suspected diagnosis would need to be confirmed with other invasive and inaccurate ROM tests such as nitrazine (pH) test or by ultrasound.

Invasive testing for PROM — including a current gold standard for accuracy, intra-amniotic injection of indigo carmine—requires considerable hospital resources, including the use of a bed and expensive machinery not all clinics can afford. This method although very accurate is not performed in the US any longer due to the invasive nature of the test. Another issue with invasive testing is the potential for infection, particularly during pre-term digital cervical examinations.

If PROM can be accurately ruled out via non-invasive fetal membrane rupture testing performed, unnecessary antibiotic and steroid administration, hospitalization, induction, and the associated costs could be avoided.

Non-Invasive Testing Options

Non-invasive testing for PROM includes the use of biomarker tests to identify the presence of amniotic fluid in vaginal discharge. Samples can be collected without a speculum exam, with results available in minutes. Products such as ROM Plus® and Actim PROM, tested for the insulin-like growth factor-binding protein (IGFBP-1). Overall accuracy was improved compared to nitrazine, fern and other testing methods, however, false positives and false negatives were still a concern.

Introducing AmniSure®

The AmniSure®, ROM Test uses the principles of immunochromatography to detect human PAMG-1 protein present in amniotic fluid. With ~99% accuracy, AmniSure represents a further refinement of non-invasive biomarker testing for PROM.

  • Caughey AB et al. Contemporary Diagnosis and Management of Preterm Premature Rupture of Membranes. Rev. Obstet. Gynecol. 2008;1(1):11–22.
  • Neil PRL, Wallace EM. Is AmniSure® useful in the management of women with prelabour rupture of the membranes? Australian and New Zealand Journal of Obstetrics and Gynaecology 2010


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