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NCT Number: NCT07840235

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.

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.

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Key information

Conditions

Preterm Labor Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institute for the Care of Mother and Child

Prague, Czechia

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Pregnolia System

Device

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.

Primary outcomes

  1. Cervical Stiffness Index (CSI), in mbar

    Time frame: 22+0 - 35+6 gestational weeks

    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

  1. Patient delivery data: gestational age at birth

    Time frame: Up to 4 weeks after delivery

    Gestational at birth (weeks)

  2. Patient delivery data: time to delivery

    Time frame: Up to 4 weeks after delivery

    Time from cervical stiffness measurement to delivery (days)

  3. Patient delivery data: onset of labor

    Time frame: Up to 4 weeks after delivery

    Onset of labor: spontaneous, induction, primary C-section, other

  4. Patient delivery data: mode of delivery

    Time frame: Up to 4 weeks after delivery

    Mode of delivery: spontaneous vaginal delivery, induced vaginal delivery, C-section, instrumented

  5. Transvaginal cervical length

    Time frame: 22+0 - 35+6 gestational weeks

    Transvaginal cervical length

  6. Cervical Stiffness Index (CSI) at discharge

    Time frame: At discharge (from 22+0 weeks onwards)

    Optional measurement of CSI at discharge

Other outcomes

  1. Health economics data: duration of hospitalization

    Time frame: Up to 4 weeks after delivery

    Duration of hospitalization (days)

  2. Health economics data: NICU length of stay

    Time frame: Up to 4 weeks after delivery

    NICU length of stay (days)

  3. Health economics data: medications/interventions

    Time frame: Up to 4 weeks after delivery

    Medications/interventions during pregnancy until delivery

  4. Device-related adverse events

    Time frame: 22+0 gestational weeks to up to 4 weeks after delivery

    Device-related adverse events (incidence, severity, and seriousness)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Pregnolia AG

Industry

Registry information

Acronym: CZECH-TPTL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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