Cervical Stiffness in Women With Threatened Preterm Labor

NCT07840235 | Not Yet Recruiting

• 1 other identifier: F-405-11 v.1, 2026-05-20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preterm Labor; Preterm Birth

Keywords

cervical stiffness

Outcome Measures

Primary Outcomes (1)

• 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.

  22+0 - 35+6 gestational weeks

Secondary Outcomes (6)

• Patient delivery data: gestational age at birth

  Up to 4 weeks after delivery

• Patient delivery data: time to delivery

  Up to 4 weeks after delivery

• Patient delivery data: onset of labor

  Up to 4 weeks after delivery

• Patient delivery data: mode of delivery

  Up to 4 weeks after delivery

• Transvaginal cervical length

  22+0 - 35+6 gestational weeks

Other Outcomes (4)

• Health economics data: duration of hospitalization

  Up to 4 weeks after delivery

• Health economics data: NICU length of stay

  Up to 4 weeks after delivery

• Health economics data: medications/interventions

  Up to 4 weeks after delivery

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with singleton pregnancies at 22+0 - 35+6 weeks gestation presenting signs and symptoms for threatened preterm labor.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pregnolia AG: lead

Study Sites (1)

Institute for the Care of Mother and Child

Prague, Czechia

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

CZ (1)