Women giving birth prematurely due to spontaneous preterm labor may exhibit signs and symptoms of preterm labor (PTL) which are mostly nonspecific. Among all women presenting in emergency with some complaints suggesting preterm labor, only about 10% will give birth within 7 days. Current clinical methods to improve diagnosis of PTL include digital examination, transvaginal cervical length assessment or the use of biomarkers; however, none of these methods have high accuracy, and it is therefore important to improve diagnosis of spontaneous PTL. There is a need for more accurate methods and tools to correctly identify imminent preterm labor in order to avoid unnecessary hospital admissions and therapy, as well as give better care for those women truly in PTL who need focused attention. Recently, cervical stiffness has been evaluated as a novel biomarker for prediction of spontaneous preterm birth. The Pregnolia System is a new CE-marked device for measuring cervical stiffness in a simple and quantitative way, providing clinicians with an immediate and actionable result. The device has been evaluated for risk stratification of women at higher risk of delivering prematurely in some European countries. However, data on cervical stiffness in Czech healthcare setting are lacking, and these findings have not yet been confirmed in this population. In this cohort study, the investigators aim to assess cervical stiffness in women with threatening PTL in a Czech cohort and to evaluate its association with delivery outcomes. Ultimately, the investigators seek to determine whether findings from other European populations can be reproduced in a Czech setting.
Study Type
OBSERVATIONAL
Enrollment
100
The Pregnolia System is a CE-marked medical device using the aspiration method. It quantifies reliably cervical stiffness by measuring the amount of vacuum required to deform cervical tissue.
Institute for the Care of Mother and Child
Prague, Czechia
Cervical Stiffness Index (CSI), in mbar
To determine the value of CSI, as measured by the Pregnolia System, in a Czech cohort of women presenting with symptoms of PTL.
Time frame: 22+0 - 35+6 gestational weeks
Patient delivery data: gestational age at birth
Gestational at birth (weeks)
Time frame: Up to 4 weeks after delivery
Patient delivery data: time to delivery
Time from cervical stiffness measurement to delivery (days)
Time frame: Up to 4 weeks after delivery
Patient delivery data: onset of labor
Onset of labor: spontaneous, induction, primary C-section, other
Time frame: Up to 4 weeks after delivery
Patient delivery data: mode of delivery
Mode of delivery: spontaneous vaginal delivery, induced vaginal delivery, C-section, instrumented
Time frame: Up to 4 weeks after delivery
Transvaginal cervical length
Transvaginal cervical length
Time frame: 22+0 - 35+6 gestational weeks
Cervical Stiffness Index (CSI) at discharge
Optional measurement of CSI at discharge
Time frame: At discharge (from 22+0 weeks onwards)
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