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AmniSure ROM Test for Detection of Fetal Membrane Rupture

March 20, 2018

Health Problem: During pregnancy, the fetal membranes contain the developing fetus and amniotic fluid and provide protection from infection. Although the membranes normally rupture during labor, in approximately 10% of pregnancies, rupture occurs before initiation of labor. Premature rupture of membranes (PROM) must be diagnosed accurately and managed correctly soon after its occurrence in order to prevent neonatal and maternal illness or death.

Technology Description: The AmniSure ROM Test (Rupture of [fetal] Membranes test) (Qiagen N.V., the Netherlands) has been developed to detect fetal membrane rupture based on the presence of placental alpha-microglobulin-1 protein (PAMG-1) in vaginal fluid.

Controversy: Although the AmniSure test is relatively easy to perform and could enable early detection of PROM, the symptoms of rupture are usually obvious. Since other methods have been developed to evaluate these aspects of PROM and suspected PROM must be thoroughly evaluated, the AmniSure test may not be necessary or useful.

Key Questions:

  • Is the AmniSure test more accurate than other methods for detection of PROM?
  • Can the information obtained with the AmniSure test be used to improve management of patients who have PROM?
  • Does the AmniSure test pose any safety issues?
  • Have patient selection criteria been established for the AmniSure test?