An observational study in Preterm Labor and Preterm Birth, sponsored by Pregnolia AG. Recruiting at 1 site in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Pregnolia AG · Observational
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Pregnolia AG is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Compared within Premature Birth, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obstetric Labor, Premature. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Women with singleton pregnancies at 22+0 - 35+6 weeks gestation presenting signs and symptoms for threatened preterm labor.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Sign and/or symptoms of threatened preterm labor: one or more of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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)
Health economics data: duration of hospitalization
Duration of hospitalization (days)
Time frame: Up to 4 weeks after delivery
Health economics data: NICU length of stay
NICU length of stay (days)
Time frame: Up to 4 weeks after delivery
Health economics data: medications/interventions
Medications/interventions during pregnancy until delivery
Time frame: Up to 4 weeks after delivery
Device-related adverse events
Device-related adverse events (incidence, severity, and seriousness)
Time frame: 22+0 gestational weeks to up to 4 weeks after delivery
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Pregnolia AG