THE CHALLENGE

Threatened Preterm Labor


Preterm Labor refers to the onset of labor before 37 weeks of pregnancy, characterized by regular uterine contractions along with documented changes in the cervix or ruptured fetal membranes. If these signs are absent, a diagnosis of Threatened Preterm Labor (TPTL) can be considered. TPTL stands as a primary cause of hospitalization during pregnancy , potentially occurring multiple times for a patient. This results in a significant economic burden, reaching approximately €8 billion in the EU and 1.2 billion in the US and EU combined, due to unnecessary hospital stays.

Of the hospitalized TPTL cases, only 15% lead to a spontaneous delivery within the following 7 days, while around 85% do not result in preterm birth. Swift and accurate differentiation between true and false TPTL diagnoses ensures that appropriate care is provided to genuine TPTL cases. Conversely, precise diagnosis of false TPTL prevents the unnecessary relocation, hospitalization, and treatment of healthy pregnant women who are not in active labor. These unwarranted interventions can lead to heightened psychological distress for both the mother and her family, increase the risk of maternal and fetal health complications, and result in avoidable costs.

 
THE CHALLENGE

Threatened 

Preterm

Labor


Preterm Labor refers to the onset of labor before 37 weeks of pregnancy, characterized by regular uterine contractions along with documented changes in the cervix or ruptured fetal membranes. If these signs are absent, a diagnosis of Threatened Preterm Labor (TPTL) can be considered. TPTL stands as a primary cause of hospitalization during pregnancy , potentially occurring multiple times for a patient. This results in a significant economic burden, reaching approximately €8 billion in the EU and 1.2 billion in the US and EU combined, due to unnecessary hospital stays.

Of the hospitalized TPTL cases, only 15% lead to a spontaneous delivery within the following 7 days, while around 85% do not result in preterm birth. Swift and accurate differentiation between true and false TPTL diagnoses ensures that appropriate care is provided to genuine TPTL cases. Conversely, precise diagnosis of false TPTL prevents the unnecessary relocation, hospitalization, and treatment of healthy pregnant women who are not in active labor. These unwarranted interventions can lead to heightened psychological distress for both the mother and her family, increase the risk of maternal and fetal health complications, and result in avoidable costs.


OUR DEVICE

The FineBirth

helps the OB/GYN Doctor differentiate between false and true preterm labor threats. Innitius’ Fine Birth is a portable diagnostic device that provides the OB/GYN Doctor with a real time risk assessment of spontaneous preterm delivery within the following ≤ 7 days after the event, dramatically reducing the negative clinical impact and the cost of over-treating false Preterm Labor (PTL) threats.

Point-of-Care diagnostics
in real time

No use constraints

 

Higher accuracy
than other methods
Cost-effective

 

 

Clinical References

  • Reproducibility and usability assessment of the novel Fine Birth device for threatened preterm labor diagnosis. FS Molina, L Pardo, MD Muñoz, A Aiartzaguena, A Valladolid, JE Blanco, J Burgos, MM Gil. American Journal of Obstetrics & Gynecology MFM 5.7 (2023): 100982.
  • A Preliminary Study on the Safety of Elastography during Pregnancy: Hypoacusia, Anthropometry, and Apgar Score in Newborns. P Massó, J Melchor, G Rus, FS Molina. Diagnostics 10 (11), 967 1 2020
  • In Vivo Measurement of Cervical Elasticity on Pregnant Women by Torsional Wave Technique: A Preliminary Study. P Massó, A Callejas, J Melchor, FS Molina, G Rus. Sensors 19 (15), 3249 13 2019
  • Transient elastography to assess the cervical ripening during pregnancy: A preliminary study. L Peralta, FS Molina, J Melchor, LF Gómez, P Massó, J Florido, G Rus. Ultraschall in der Medizin-European Journal of Ultrasound 38 (04), 395-402 38 2017
  • On the safety of elastography in fetal medicine: A preliminary study of hypoacusia. P Massó, F Molina, G Rus Carlborg. John Wiley and Sons 12 2017