Cervical Stiffness in Women With Threatened Preterm Labor

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorPregnolia AG

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
22+0 - 35+6 gestational weeks

Secondary outcomes

1

Patient delivery data: gestational age at birth

Gestational at birth (weeks)

Time frame
Up to 4 weeks after delivery
2

Patient delivery data: time to delivery

Time from cervical stiffness measurement to delivery (days)

Time frame
Up to 4 weeks after delivery
3

Patient delivery data: onset of labor

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

Time frame
Up to 4 weeks after delivery
4

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

Other outcomes

1

Health economics data: duration of hospitalization

Duration of hospitalization (days)

Time frame
Up to 4 weeks after delivery
2

Health economics data: NICU length of stay

NICU length of stay (days)

Time frame
Up to 4 weeks after delivery
3

Health economics data: medications/interventions

Medications/interventions during pregnancy until delivery

Time frame
Up to 4 weeks after delivery
4

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

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: