INFORMATION
FOR
PROFESSIONALS
The first Application that can
measure cervical stiffness
The biomechanical properties of the cervix, and in particular its stiffness, have become significantly more important in recent years and are increasingly the focus of scientific attention.
Because cervical stiffness is an early indicator of the maturation of the cervix, it supports the assessment of preterm birth risk. [1] [3] [4] [5]
Pregnolia is taking an innovative step into the future with our cervical stiffness measurement device as we provide professionals with a new tool for prenatal care.
​
how the device works
The Pregnolia System consists of a single-use sterile probe and a control unit. The probe is placed in contact with the anterior lip of the cervix with the help of a speculum. The measurement is started by operating the foot switch, creating a small vacuum inside the probe tip which gently pulls on the tissue. The softer the tissue, the weaker the vacuum required to deform the cervical tissue by 4mm. Within a few seconds the measurement is complete and the control unit displays the cervical stiffness index (CSI) as a negative pressure value (pcl in mbar).
Using the reference curve, the measured stiffness can be compared to values from physiological pregnancy (percentiles). Thus, the cervical stiffness measurement complements the anamnesis and cervical length measurement to obtain a more complete picture of the cervical changes during pregnancy.
Current clinical findings
​
-
The cervix softens before it shortens [1]
-
Quantitative determination of cervical stiffness is more reliable than palpation [2]
-
Early study results show that cervical stiffness is more informative than cervical length
More information about the studies
ADVANTAGES OF THE PREGNOLIA System[1]
-
quantitative and objective measurement of cervical stiffness
-
safe and simple application
-
takes only a few minutes
Learn more about Pregnolia and how customers use the system:
The path to individualised
risk assessment
The goal is evidence-based prediction of the start of delivery, based on the cervical stiffness. The focus is on preterm birth detection. However, studies are also running in the area of induction of labour.
Studies
-
Physiological pregnancies
-
High-risk pregnancies
-
Symptomatic pregnancies
-
Induction of labour
Individualised risk assessment
System with evidence-based prediction of the start of delivery (future device).
References
​
​
[1] Badir S. et al., Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique.
Prenatal Diagnosis 2013; 33(8): 737-741.
​
[2] Badir S. et al., Aspiration technique-based device is more reliable in cervical stiffness assessment than digital palpation.
BMC Pregnancy and Childbirth 2020; 20 (391).
[3] Parra-Saavedra M. et al., Prediction of preterm birth using the cervical consistency index. Ultrasound Obstet Gynecol 2011; 38: 44–51.
[4] Baños, Núria, et al. Mid-trimester cervical consistency index and cervical length to predict spontaneous preterm birth in a high-risk population.
American Journal of Perinatology Reports 8.01 (2018): e43-e50.
​
[5] Baños, Núria, et al. Mid-trimester sonographic cervical consistency index to predict spontaneous preterm birth in a low-risk population. Ultrasound
in Obstetrics & Gynecology 51.5 (2018): 629-636.
​