INFORMATION
FOR
PROFESSIONALS
Pregnolia has developed a new medical device that improves the state of pregnancy care. The result of several years of academic research at ETH Zürich and University Hospital Zürich, the device enables the precise measurement of cervical stiffness [1].
ADVANTAGES OF THE PREGNOLIA System[1] [2]
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quantitative and objective measurement of cervical stiffness
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safe and simple application
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takes only a few minutes
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high resolution stiffness scale
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less intrusive than digital palpation
Learn more about Pregnolia and how customers use the system:
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 a 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).
Studies
A prototype of the device was tested in 2010–2012 in a feasibility study carried out on 50 non-pregnant women and 50 pregnant women. The aim was to record the changes in cervical stiffness throughout a normal pregnancy. The study showed that as pregnancy progresses, the cervix becomes softer, and also that the cervix softens months before it shortens (Figure 1). This allows the Pregnolia System to detect changes in the cervical tissue earlier than would be possible by measuring the cervical length with ultrasound [1].
Clinical data (n=1115) have shown [3] that pregnant women with a soft cervix are much more likely to have spontaneous preterm births than women with physiological cervical maturation (Figure 2).
In the multi-center clinical study "SoftCervix", research is currently being conducted into how the length and stiffness of the cervix correlate with the time of birth [4]. The results of the study are expected to be available in 2022.
Overview of scientific articles about the Pregnolia System:
Aspiration technique-based device is more reliable in cervical stiffness assessment than digital palpation
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The Pregnolia System revamps a classical gynaecological assessment, cervical palpation. Cervical stiffness measured with our device is considerably more reliable than digital palpation.
Check out the video.
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Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique
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The Pregnolia System measures cervical stiffness: the device was used in 50 non-pregnant and 50 pregnant women to measure cervical stiffness in normal pregnancies.
Objective assessment of cervical stiffness after administration of misoprostol for intrauterine contraceptive insertion
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The influence of misoprostol on cervical stiffness is assessed via measuring the stiffness in misoprostol users prior to intrauterine contraceptives insertion and at follow-up consultation with the Pregnolia System.
The Pregnolia System is currently used in the following clinical studies:
ATOPS
In this trial, cervical stiffness is measured in high risk, randomized groups with and without a cervical pessary. The measurement is accompanied by ultrasound imaging and the stiffness and geometric information is used together for computer modeling of the mechanical environment of each pregnancy.
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References
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[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.
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[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] SoftCervix study: https://clinicaltrials.gov/ct2/show/NCT02037334
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