PORTEFEUILLE

One in ten babies or 15 million babies worldwide are born preterm every year, a life-threatening event for baby and traumatic event for families, with a multi-billion cost impact for our society. Even in developed countries the current diagnostic methods have not been able to reduce these rates.
The uterine cervix, the lower part of the uterus where the fetus is accommodated, has to remain closed until term to allow the development of the fetus. That is why the assessment of the cervical “competence” (essentially its stability) plays an essential role in the risk assessment of preterm birth.

A novel device, assessing the uterine cervix, might enable a step-change in improving the gold standard to detect the risk of preterm birth and could drastically reduce the number of prematurely delivered babies. The aim of this project is to translate this research instrument into a commercially viable prototype ready for industrialization.

Digital palpation of the uterine cervix has been essential during routine examination to assess cervical stiffness and cervical length in order to diagnose the risk of preterm. With the introduction of transvaginal ultrasound in early 90‘s, palpation was mainly substituted by a quantitative measurement of cervical length using ultrasound. However, a quantitative measure for cervical stiffness has not found its way into clinical practice due to major technical challenges.

The developed device quantitatively determines the cervical tissue stiffness of a pregnant woman and its changes during pregnancy. By detecting abnormal changes to the stiffness, the device can instantly diagnose a weak cervix and thus the likelihood of preterm birth. First clinical evidence shows that the sensitivity to detect the risk for preterm delivery could increase from 30 to 80%.

In this project, we have translated an existing research instrument developed at ETH into medical device ready for industrialization.

Beginning of 2017, a next-generation camera-free aspiration method to measure cervical stiffness in pregnancy was developed and produced. This new design underwent a profound evaluation process to get the best solution for a reliable, efficient and safe measurement device. High-quality manufacturing partner are established providing the technology to produce the product in future in high volumes with optimized costs. The device was tested by several gynecologists in the laboratory and in the clinical practice. This validation has shown that the design, usability and performance of the device meet the initial requirements that we defined at the beginning of this project.

This diagnostic tool is ready to be transferred into the next stage. The industrialization and the CE marking of the device will be carried out by the Spinoff company pregnolia.
Such an instrument shall enable obstetricians to make early decisions about preterm birth management and pregnant women to be informed of their risk such that they can adapt their lifestyle. By prolonging pregnancy until term, not only a significant fraction of health care costs are decreased, but also the number of neonatal deaths and long-term diseases that accompany the newborn throughout its life are reduced.

Badir, S., et al. A novel procedure for the mechanical characterization of the uterine cervix during pregnancy. J Mech Behav Biomed Mat, 27:143– 153 (2013);
Badir, S., et al. Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique. Prenat Diag, 33(8):737–41 (2013);
«Früherkennung und Vorsorge in der Schwangerschaft», 19. Ostschweizer Symposium für praktische Gynäkologie und Geburtshilfe. 10.-11. November 2016, Näfels GL
Badir, S and Bissig, M (2017). Frühchen früh erkennen mithilfe einer neuen Sonde. Hebamme.ch 9/2017

Sabrina Badir, Erfinderin: «In Mathe war ich eine Null!» (April 2017)
Frühchen früher finden (Februar 2016)
Gerät erkennt Frühchen frühzeitig (Januar 2016)
Frühchen vermeiden: Mit neuem Test Frühgeburten zurvor kommen (Dezember 2015)
Identifying the risk of premature birth (November 2015)
Ein Fest der Erfolgsgeschichten (Juni 2015)