Spontaneous rupture of membranes can occur at any gestational age and presents a particularly serious clinical problem if it occurs prior to 37 weeks gestation where it is responsible for 20%–40% of preterm births. Thus, accurate and timely diagnosis of membrane rupture is imperative to inform and guide gestational age-specific interventions to optimize perinatal outcomes and reduce the risk of serious complications, including preterm delivery and infections such as chorioamnionitis and neonatal sepsis.
An incorrect diagnosis of membrane rupture (i.e. false positive test) can also have serious clinical ramifications, such as the initiation of unnecessary obstetrical interventions that may include hospitalization, administration of medications, and even iatrogenic premature delivery. They approached Timestrip for Time indicators which would be required for these test devices.