About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton gestation
Aged ≥18 years
Able to give informed consent
Between 22 weeks, 0 days and 35 weeks, 6 days of gestation
Disqualifiers
Signs of imminent labor such as strong, painful and intense contractions (strong suspicion of true labor).
Cervical dilatation ≥ 3 cm
Signs of intrauterine infection / amnionitis
Obstetric indication for immediate delivery (advanced labor, cord prolapse, placenta abruption, signs of fetal distress)
Trial population
Women with singleton pregnancies at 22+0 - 35+6 weeks gestation presenting signs and symptoms for threatened preterm labor.
Trial design
Cohort
Prospective
Treatments tested in this trial
Pregnolia System
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Patient delivery data: gestational age at birth
Gestational at birth (weeks)
Patient delivery data: time to delivery
Time from cervical stiffness measurement to delivery (days)
Patient delivery data: onset of labor
Onset of labor: spontaneous, induction, primary C-section, other
Patient delivery data: mode of delivery
Mode of delivery: spontaneous vaginal delivery, induced vaginal delivery, C-section, instrumented
Other outcomes
Health economics data: duration of hospitalization
Duration of hospitalization (days)
Health economics data: NICU length of stay
NICU length of stay (days)
Health economics data: medications/interventions
Medications/interventions during pregnancy until delivery
Device-related adverse events
Device-related adverse events (incidence, severity, and seriousness)
Sponsors and contacts
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