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Aspiration Technique-based Device for Preterm Labor (PREGNOLIA)

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ClinicalTrials.gov Identifier: NCT05355649
Recruitment Status : Recruiting
First Posted : May 2, 2022
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Gabriele Saccone, Federico II University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Preterm Labor Preterm Birth Device: PREGNOLIA SYSTEM Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: PREGNOLIA SYSTEM
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of a New Aspiration Technique-based Device for Assessment of Cervical Stiffness in Pregnant Women With Symptoms of Preterm Labour
Actual Study Start Date : April 8, 2022
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Value of the system in women with symptoms of preterm labor [ Time Frame: up to 34 weeks ]
    detection rate of PREGNOLIA system in women with symptoms of preterm labor (sensitivity, specificity, detection rate).


Secondary Outcome Measures :
  1. Birth outcomes [ Time Frame: up to 34 weeks ]
    Correlation between the system of the results and birth outcome (gestational age at birth, time to delivery, mode of delivery)

  2. Comparison between pregnolia system and cevical length [ Time Frame: up to 34 weeks ]
    Detection rate of the two systems

  3. the change of the calcaneus stiffness index (CSI) at triage and discharge [ Time Frame: up to 34 weeks ]
    to determine the change of the CSI at triage and discharge


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05355649


Contacts
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Contact: Gabriele Saccone, md 0817461111 gabriele.saccone.1990@gmail.com

Locations
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Italy
Gabriele Saccone Recruiting
Naples, Italy, 80100
Contact: Gabriele Saccone    0817461111    gabriele.saccone.1990@gmail.com   
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Gabriele Saccone, md federico ii
More Information
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Responsible Party: Gabriele Saccone, Principal investigator, Federico II University
ClinicalTrials.gov Identifier: NCT05355649    
Other Study ID Numbers: VanvFedII
First Posted: May 2, 2022    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not planned yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications