INFORMATION
FOR
PROFESSIONALS
Pregnolia develops a medical device for the improvement of pregnancy care. The device is the result of several years of academic research at ETH Zurich and University Hospital Zurich and allows to measure cervical stiffness. The CE-marking is expected for spring 2019.
ADVANTAGES OF THE PREGNOLIA System[1]
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quantitative und objective measurement of cervical stiffness
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simple and painless application
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the changes in biomechanical properties of the cervix are detected earlier before the cervical length changes
how the device works
The Pregnolia System consists of a probe and a control unit with display. The probe is placed on the anterior lip of the cervix with the help of a speculum. By pressing the button, which can also be activated by the foot, a weak vacuum is created. The softer the tissue, the lower the required vacuum to deform the tissue up to 4mm. Within a few seconds, the device determines the cervical stiffness in the means of the required negative pressure (pcl in mbar).
Studies
A prototype of the Pregnolia System has already been tested on 50 non-pregnant and 50 pregnant women. The study has shown that the cervix softens, before it shortens. This characteristics allows to detect cervical changes earlier with the Pregnolia System than by an ultrasound assessment [1].
First clinical data (n=1115) have shown [2] that women with a soft cervix have more often a spontaneous preterm birth than women with a physiologic cervical maturation.
In the ongonig multicenter study SoftCervix [3], the correlation of cervical length and stiffnesss with the time of delivery is further investigated. The results of this study are expected in 2019.
[1] Badir, S. et al. (2013). Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique. Prenat Diagn, 33(8), 737–741
[2] Parra-Saavedra, M. et al. (2011). Prediction of preterm birth using the cervical consistency index. Ultrasound Obstet Gynecol, 38(1), 44–51
[3] https://clinicaltrials.gov/ct2/show/NCT02037334 (Stand 08.03.2018)
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