FDA Issues Warning for ‘Over Reliance’ on Rupture of Membrane Tests

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 secretions.

“Our review of the risks associated with improper use of these ROM tests is ongoing, but we want to be transparent with providers and patients about the information that we have indicating an issue, and provide recommendations to minimize the risks,” said Courtney Lias, Ph.D., director of the FDA’s Division of Chemistry and Toxicology Devices, in a statement.

Takeaway: The FDA is warning clinicians to adhere to the recommended use of ROM tests as a component of a comprehensive clinical assessment in pregnant women.