EASY, FAST & RELIABLE

NOVEL TEST TO PREDICT THE RISK OF PRETERM BIRTH

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

The PartoSure Test, currently for investigational use only in the United States, is a revolutionary tool in determining the risk of preterm labor.

  1. Sanchez-Ramos et al. Obstet Gynecol 2009; 114: 631-40.
  2. Schaaf et al. BJOG 2011; 118: 1196-1204.
  3. McPheeters et al. Am J Obstet Gynecol 2005; 192: 1325-9.
  4. Ness et al. Am J Obstet Gynecol 2007; 197: 426.e1–426.e7.
  5. Alfirevic et al. Ultrasound Obstet Gynecol 2007; 29: 47–50.
  6. Lucovnik M, Chambliss LR, Garfield RE. Costs of unnecessary admissions and treatments for “threatened preterm labor”. Am J Obstet Gynecol. 2013 Sep;209(3):217.e1-3.
  7. Guinn DA et al. Single vs. weekly courses of antenatal corticosteroids for women at risk of preterm delivery: a randomized controlled trial. JAMA 2001; 286: 1581–1587.
  8. Antenatal corticosteroids revisited: repeat courses. NIH Consensus Statement 2000;17(2): 1-18
  9. Murphy et al. Lancet. 2008 Dec 20;372(9656):2143-51.
  10. Berghella V, Saccone G. Fetal fibronectin testing for prevention of preterm birth in singleton pregnancies with threatened preterm labor: a systematic review and metaanalysis of randomized controlled trials. Am J Obstet Gynecol 2016; 215: 431-8.
  11. Peaceman AM et al. Fetal Fibronectin as a predictor of preterm birth in patients with symptoms: a multicenter trial. Am J Obstet Gynecol 1997;177:13-8.