Aspiration Technique-based Device for Preterm Labor (PREGNOLIA)

Impact of a New Aspiration Technique-based Device for Assessment of Cervical Stiffness in Pregnant Women With Symptoms of Preterm Labour

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).

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Preterm Labor
• Intervention / Treatment: Device: PREGNOLIA SYSTEM

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriele Saccone, md; Phone Number: 0817461111; Email: gabriele.saccone.1990@gmail.com

Study Locations

• Italy
  • Naples, Italy, 80100
    • Recruiting
    • Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: PREGNOLIA SYSTEM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth outcomes	Correlation between the system of the results and birth outcome (gestational age at birth, time to delivery, mode of delivery)	up to 34 weeks
Comparison between pregnolia system and cevical length	Detection rate of the two systems	up to 34 weeks
the change of the calcaneus stiffness index (CSI) at triage and discharge	to determine the change of the CSI at triage and discharge	up to 34 weeks

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Gabriele Saccone, md, Federico II

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: VanvFedII

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: not planned yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No