Health care providers may be over relying on rupture of membrane (ROM) test results when making critical patient management decisions, according to a U.S. Food and Drug Administration (FDA) warning. The FDA says it is concerned that this misuse (over reliance) could harm women and their fetuses. The agency says that despite labeling instructions to the contrary, clinicians may be using these test results to independently diagnose ROM in pregnant women, without using other clinical assessments. Routine postmarket surveillance filed with the agency shows that 15 fetal deaths and multiple cases of health complications in pregnant women may be tied to use of ROM tests. The timing of sample collection and testing, the presence of blood, meconium, antifungal creams, or lubricants from vaginal exams can all affect the results. A negative test result does not definitively rule out ROM. ROM refers to a break in the amniotic membranes, which could be a rapid release of amniotic fluid or a small trickle. While ROM is a normal part of labor, premature rupture increases the risk of infection and injury to the fetus and the pregnant woman. ROM tests are point-of-care tests that provide on-site information to providers using analysis of vaginal […]