28% of patients presenting with signs and symptoms of threatened preterm labor may be admitted to the hospital.1,2
Only 5 to 10% of these patients go on to deliver within 7 days, resulting in up to 85% of unnecessary and avoidable admissions.3,4,5
A single unnecessary admission of a patient suspected of having preterm labor but who does not actually go on to deliver imminently costs $20,300 USD on average.6
Therefore, there is a clear and urgent need for more accurate ways to identify women truly at risk of preterm delivery in order to avoid unnecessary admissions and the administration of potentially harmful therapeutics.
Clinical evaluation alone, including the measurement of cervical length and dilatation, is not sufficiently predictive of imminent delivery among patients with signs of threatened preterm labor.
Similarly, currently available biomarker tests, such as that which is based on the detection of fetal fibronectin (fFN), have high negative predictive values on the one hand, but extremely poor positive predictive values for imminent delivery on the other hand, leading to many false positive results causing unnecessary costs to the system and burden to the patients.
After a systematic review and meta-analysis of randomized controlled clinical trials of fFN, “…the initial promise for fetal fibronectin testing in women with threatened preterm labor (i.e. avoidance of unnecessary interventions and hospital admissions at no cost to rate of preterm birth) has not been realized…In fact, hospital costs may be higher when fetal fibronectin results are used in clinical management.”10,11