Preterm LaborCZECH-TPTLNCT07840235
Cervical Stiffness in Women With Threatened Preterm Labor
An observational study of Preterm Labor and Preterm Birth, run by Pregnolia AG at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Labor, Preterm Birth
- What is being tested?
- Pregnolia System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Oct 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women with singleton pregnancies at 22+0 - 35+6 weeks gestation presenting signs and symptoms for threatened preterm labor.
Who may be able to join
- Singleton gestation
- Aged ≥18 years
- Able to give informed consent
- Between 22 weeks, 0 days and 35 weeks, 6 days of gestation
- An ultrasound performed within 6 hours prior to CSI assessment, or after CSI assessment, showing a closed external cervical os and absence of bulging of the membranes into the cervical canal. If ultrasound was conducted by referring hospital, it shall be repeated as part of the study.
- At speculum or vaginal examination: cervical dilation less than 3 cm and no membrane seen or palpated.
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- Intact membranes
- Sign and/or symptoms of threatened preterm labor: one or more of the following:
- Abdominal pain or cramps
- Uterine contractions, felt or unfelt
- Bloody show ("spotting" or light bleeding)
- Pelvic pressure
- Low back pain (continuous or intermittent)
Who cannot join
- 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)
- Confirmed fetal abnormality
- Fetal death
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- Known or suspected rupture of membranes
- Confirmed vasa / placenta previa
- Severe active vaginal bleeding
- Light bleeding that cannot be stopped
- Cerclage or pessary in place
- Müllerian anomalies
- Female genital mutilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Institute for the Care of Mother and Child
Prague
Lubomír Hašlík, lubomir.haslik@upmd.eu
About this study
Official title: Cervical Stiffness in Women With Threatened Preterm Labor: a Czech Cohort Study
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.
Read more
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.
- Conditions
- Preterm Labor, Preterm Birth
- Being tested
- Pregnolia System
- Keywords
- cervical stiffness
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnolia SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22+0 - 35+6 gestational weeks
Secondary outcomes (6)
Patient delivery data: gestational age at birth
Gestational at birth (weeks)
Measured: Up to 4 weeks after delivery
Patient delivery data: time to delivery
Time from cervical stiffness measurement to delivery (days)
Measured: Up to 4 weeks after delivery
Patient delivery data: onset of labor
Onset of labor: spontaneous, induction, primary C-section, other
Measured: Up to 4 weeks after delivery
Patient delivery data: mode of delivery
Mode of delivery: spontaneous vaginal delivery, induced vaginal delivery, C-section, instrumented
Measured: Up to 4 weeks after delivery
Transvaginal cervical length
Transvaginal cervical length
Measured: 22+0 - 35+6 gestational weeks
Cervical Stiffness Index (CSI) at discharge
Optional measurement of CSI at discharge
Measured: At discharge (from 22+0 weeks onwards)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pregnolia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840235
- Sponsor's protocol ID
- F-405-11 v.1, 2026-05-20
- Acronym
- CZECH-TPTL
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided