Aspiration Technique-based Device for Preterm Labor

NCT05355649 | Unknown

• 1 other identifier: VanvFedII
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Premature birth (PTB, birth before 37 weeks of pregnancy) is a global, yet unsolved, problem. With a global amount of approximately 15 M babies born prematurely, PTB is the leading cause of perinatal morbidity and mortality in many countries. Furthermore, premature babies often have complicated medical problems, especially those born very early. Some women spontaneously deliver prematurely without any symptom or sign of the imminent labor, whereas others present with symptoms of preterm labor (PTL). In the latter case, clinicians can intervene and treat the woman with tocolytics and antenatal corticosteroids in order to accelerate fetal lung maturation and reduce the risk of respiratory distress syndrome. However, one of the major challenges in the management of women presenting with symptoms of PTL is to distinguish between true and false PTL with the existing clinical methods (digital examination or transvaginal cervical length assessment). In fact, over 50% of the women presenting with PTL symptoms do not deliver prematurely and are still unnecessarily hospitalized and treated with corticosteroids as well as tocolytics, and only less than 10% of women give birth within 7 days of presentation. Unnecessary treatments and hospitalizations also result in increased health costs. Thus, there is a need for more accurate methods and tools to evaluate the cervical maturation status as indication of imminent labor in order to avoid unnecessary hospital admissions and therapy. Recently, cervical stiffness has been evaluated as more reliable tool for prediction of spontaneous preterm birth. Cervical stiffness can be evaluated using ultrasound by cervical elastography , but also by an aspiration technique-based method with a novel CE-marked device, the Pregnolia System. Thus, the aims of this study are to evaluate:

• if the cervical stiffness measured with the Pregnolia System can differentiate between women with true PTL and those with false PTL,
• if the knowledge of cervical stiffness improves the detection of women at true risk of spontaneous preterm birth in combination or over state of the art (e.g. cervical length on TVUS).

Conditions

Preterm Labor; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Value of the system in women with symptoms of preterm labor

  detection rate of PREGNOLIA system in women with symptoms of preterm labor (sensitivity, specificity, detection rate).

  up to 34 weeks

Secondary Outcomes (3)

• Birth outcomes

  up to 34 weeks

• Comparison between pregnolia system and cevical length

  up to 34 weeks

• the change of the calcaneus stiffness index (CSI) at triage and discharge

  up to 34 weeks

Study Arms (1)

PREGNOLIA TEST

OTHER

Women at the time of triage will be tested with TVU CL (transvaginal ultrasound cervical length) and with the PREGNOLIA system

Device: PREGNOLIA SYSTEM

Interventions

PREGNOLIA SYSTEM DEVICE

The Pregnolia System is composed of two products: an active device (Pregnolia Control Unit) and a single-use sterile probe (Pregnolia Probe). The intended use of the Pregnolia System is to provide information about the mechanical properties of the uterine cervix by assessing the tissue stiffness through a proxy parameter (the closing pressure, denominated CSI, or Cervical Stiffness Index, in mbar). The Pregnolia System is intended to be used in conjunction with the information obtained from the clinical evaluation of the patient and in addition to other standard examinations.

PREGNOLIA TEST

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton gestations with symptoms of preterm labor
• Gestational age between 24 and 33 weeks
• Maternal age ≥18 years

You may not qualify if:

• Cervical dilatation ≥ 3 cm;
• Rupture of membranes;
• Cerclage or pessary in place;
• Severe vaginal bleeding;

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Gabriele Saccone

Naples, 80100, Italy

RECRUITING

Related Publications (1)

• Colacurci D, Saccone G, Ammendola A, Buonomo G, Murolo C, Locci M. Cervical Stiffness Index as predictor of preterm birth in women with threatened preterm labor. Eur J Obstet Gynecol Reprod Biol. 2025 Dec 23;318:114910. doi: 10.1016/j.ejogrb.2025.114910. Online ahead of print.

  PMID: 41456565 DERIVED

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 Officials

• Gabriele Saccone, md

  federico ii

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Saccone, md

CONTACT

0817461111; gabriele.saccone.1990@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: PREGNOLIA SYSTEM

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: May 2, 2022
• Study Start: April 8, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

IT (1)