Preterm LaborPREGNOLIANCT05355649
Aspiration Technique-based Device for Preterm Labor
A study testing PREGNOLIA SYSTEM in people with Preterm Labor and Preterm Birth, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Labor, Preterm Birth
- What is being tested?
- PREGNOLIA SYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton gestations with symptoms of preterm labor
- Gestational age between 24 and 33 weeks
- Maternal age ≥18 years
Who cannot join
- Cervical dilatation ≥ 3 cm;
- Rupture of membranes;
- Cerclage or pessary in place;
- Severe vaginal bleeding;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gabriele Saccone
Naples, 80100
Gabriele Saccone, 0817461111, gabriele.saccone.1990@gmail.com
About this study
Official title: 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.
Read more
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).
Read the 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).
- Conditions
- Preterm Labor, Preterm Birth
- Being tested
- PREGNOLIA SYSTEM
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREGNOLIA SYSTEMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PREGNOLIA TEST | Other | Women at the time of triage will be tested with TVU CL (transvaginal ultrasound cervical length) and with the PREGNOLIA system Receives: Device: PREGNOLIA SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 34 weeks
Secondary outcomes (3)
Birth outcomes
Correlation between the system of the results and birth outcome (gestational age at birth, time to delivery, mode of delivery)
Measured: up to 34 weeks
Comparison between pregnolia system and cevical length
Detection rate of the two systems
Measured: 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
Measured: up to 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start8 Apr 2022
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PREGNOLIA SYSTEM
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
- Investigators
- Gabriele Saccone, md, Principal investigator, federico ii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355649
- Sponsor's protocol ID
- VanvFedII
- Acronym
- PREGNOLIA
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not planned yet
Publications
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. 2026 Feb 20;318:114910. doi: 10.1016/j.ejogrb.2025.114910. Epub 2025 Dec 23.
PubMed 41456565
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a New Aspiration Technique-based Device for Assessment of Cervical Stiffness in Pregnant Women With Symptoms of Preterm Labour
- ClinicalTrials.gov ID
- NCT05355649
- Acronym / sponsor ID
- PREGNOLIA / VanvFedII
- Conditions
- Preterm Labor, Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PREGNOLIA SYSTEM
| Arm | Type | Receives |
|---|---|---|
| PREGNOLIA TEST | Other | Device: PREGNOLIA SYSTEMWomen at the time of triage will be tested with TVU CL (transvaginal ultrasound cervical length) and with the PREGNOLIA system |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Singleton gestations with symptoms of preterm labor
- Gestational age between 24 and 33 weeks
- Maternal age ≥18 years
Key exclusion criteria (4 listed)
- Cervical dilatation ≥ 3 cm;
- Rupture of membranes;
- Cerclage or pessary in place;
- Severe vaginal bleeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREGNOLIA SYSTEMThe 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. | Device | PREGNOLIA TEST |
Primary outcome
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).
3 secondary outcomes
Birth outcomes
Time frame: up to 34 weeks
Comparison between pregnolia system and cevical length
Time frame: up to 34 weeks
the change of the calcaneus stiffness index (CSI) at triage and discharge
Time frame: up to 34 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 41456565Colacurci 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. 2026 Feb 20;318:114910. doi: 10.1016/j.ejogrb.2025.114910. Epub 2025 Dec 23.
- Individual participant dataSharing planned: Undecided. not planned yet
Related trials for Preterm Labor
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Saccone, md principal investigator
federico ii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREGNOLIA SYSTEM in people with Preterm Labor and Preterm Birth, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Saccone, md (0817461111, gabriele.saccone.1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of the system in women with symptoms of preterm labor (time frame: up to 34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05355649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.