Threatened Preterm LaborFB-CT2NCT06968364
FB-CT2 Includes Two Prospective, Multi-centre Studies With a Medical Device in Hospital Settings: a Randomized, Dual-arm, Open-label Pilot Study in Spain, Followed by a Single-arm, Non-randomized, Open-label International Pivotal Study
A study testing Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation. and Transvaginal ultrasound in people with Threatened Preterm Labor, run by Ultrasound-Innovation Medtech, S.L. at 14 sites in Spain.
Trial summary
The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm labor (TPTL), between 28+0 and 36+6 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Threatened Preterm Labor
- What is being tested?
- Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation. and Transvaginal ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 14 sitesSpain
- Study dates
- 10 May 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female ≥18 years
- Singleton pregnancy
- Live fetus, 28w+0d-36w+6d GA
- Intact membranes
- Cervical dilatation <2 cm
- Signed informed consent
- Regular uterine contractions (≥8/60 min) (Pivotal only)
Who cannot join
- Latex allergy
- Prolapsed membranes
- Fetal malformation
- Fetal infection
- Vaginal bleeding (severe or persistent)
- Cervical cerclage
Show all 12Show fewer
- Müllerian anomalies
- Pessary use
- Regular uterine contractions (reported by patient) (Pilot only)
- History of preterm birth or TPTL (Pilot only)
- Vasa/placenta previa (Pilot only)
- Gastrointestinal or urinary infections (Pivotal only)
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Spain14 sites, 14 recruiting
- Not yet recruiting
H. Universitario de A Coruña
A Coruña
Nuria Valiño, +34 981 178 000, atencion.paciente.chuac@sergas.es
- Not yet recruiting
H. Clínic de Barcelona
Barcelona
Teresa Cobo, +34 93 227 54 00, marvives@clinic.cat
- Not yet recruiting
H. Sant Joan de Déu
Barcelona
Sílvia Ferrero, +34 93 253 21 00, atenciousuari@sjdhospitalbarcelona.org
- Not yet recruiting
H. Vall d'Hebron
Barcelona
María del Mar Goya Canino, +34 934 893 000, web@vallhebron.cat
- Recruiting
H. Universitario de Basurto
Bilbao
Amelia Valladolid Urdangaray, +34 944 006 000, sapu.basurto@osakidetza.eus
- Recruiting
H. Universitario de Cruces
Bilbao
Jorge Burgos San Cristóbal, 946 006 000, hospitalde.cruces@osakidetza.eus
- Not yet recruiting
H. Universitario de Donostia
Donostia / San Sebastian
Miren Arrue Arrue, +34 943 007 000, osid.sapu@osakidetza.eus
- Recruiting
H. Universitario San Cecilio
Granada
Francisca Molina García, +34 958 02 43 43, infoclinicogranada.husc.sspa@juntadeandalucia.es
- Not yet recruiting
H. Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria
Silvia de León Socorro, +34 928 444 000, gerenciachmi@gobiernodecanarias.org
- Not yet recruiting
H. General Universitario Gregorio Marañón
Madrid
Santiago García-Tizón Larroca, +34 91 586 80 00, sap.hgugm@salud.madrid.org
- Recruiting
H. Universitario de Torrejón
Madrid
Maria del Mar Gil Mira, +34 91 626 26 00, informacioncitas@torrejonsalud.com
- Not yet recruiting
H. Universitario La Paz
Madrid
Marcos Javier Cuerva González, +34 91 727 70 00, comunicacion.hulp@salud.madrid.org
- Not yet recruiting
H. Universitario de Málaga
Málaga
Jesús Jiménez López, +34 951 290 000, unidadinformacion.hvv.sspa@juntadeandalucia.es
- Not yet recruiting
H. Virgen Arrixaca
Murcia
José Eliseo Blanco Carnero, +34 968 36 95 00, sau.area1@carm.es
About this study
Official title: Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study
The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm labor (TPTL), between 28+0 and 36+6 weeks of gestation. The main questions it aims to answer are:
Does the Cervisense TPTL device predict spontaneous preterm birth within 7 days?
Read more
Is the device safe and technically reliable in a hospital setting?
Researchers will conduct a Pilot Study (randomized, dual-arm) followed by a Pivotal Study (single-arm) to assess technical feasibility and predictive performance.
Participants will undergo an intravaginal measurement of cervical stiffness using the Cervisense Intravaginal Probe. They will be followed for 14 days after the assessment to record delivery outcomes and any adverse events.
Read the detailed description
The study titled "Evaluation of the safety and the preterm birth predictive capacity of the clinical investigation device 'Cervisense TPTL': an international clinical study" is designed to assess both the safety and performance of the Cervisense TPTL device in predicting spontaneous preterm birth. It is being conducted across various Gynaecology, Obstetrics, and Emergency Services in hospitals throughout Spain and Germany.
Cervisense TPTL is the investigational product being evaluated. It includes two components: the Cervisense Intravaginal Probe V0.1, which measures cervical stiffness, and the Fine Birth algorithm, which combines the measurement with clinical data to assess the short-term risk of spontaneous preterm labor.
The device is intended for use in pregnant women showing symptoms of threatened preterm labor (TPTL), with intact amniotic membranes and a single fetus, between 28 weeks and 36 weeks plus 6 days of gestation. Its purpose is to determine the risk of spontaneous preterm birth within the following 7 days.
The clinical investigation is structured in two phases. The pilot study is a randomized, dual-arm, open-label, interventional, multi-centre study conducted in Spain. Participants are randomized 1:1 to receive either the standard of care or the Cervisense evaluation. The pivotal study is non-randomized and single-arm, also open-label and interventional, conducted at a larger scale across multiple centres in both Spain and Germany.
The main goal is to confirm that the device is safe to use and reliable in clinical settings. For safety, all adverse events associated with the use of the device are documented and analyzed in terms of severity, duration, and required intervention. Special attention is given to potential complications such as tissue trauma or infection. To ensure unbiased evaluation, a Clinical Events Committee and a Data Safety Monitoring Board have been established to independently review adverse events and guide study continuation.
Inclusion Criteria:
- Female ≥18 years
- Singleton pregnancy
- Live fetus, 28w+0d-36w+6d GA
- Intact membranes
- Cervical dilatation <2 cm
- Signed informed consent
- Regular uterine contractions (≥8/60 min) (Pivotal only)
Exclusion Criteria:
- Latex allergy
- Prolapsed membranes
- Fetal malformation
- Fetal infection
- Vaginal bleeding (severe or persistent)
- Cervical cerclage
- Müllerian anomalies
- Pessary use
- Regular uterine contractions (reported by patient) (Pilot only)
- History of preterm birth or TPTL (Pilot only)
- Vasa/placenta previa (Pilot only)
- Gastrointestinal or urinary infections (Pivotal only)
- Conditions
- Threatened Preterm Labor
- Being tested
- Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation., Transvaginal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.Device
The Cervisense Intravaginal Probe V0.1 measures cervical stiffness. It is an in-vivo predictive technology that, by using torsional waves, quantifies the mechanical properties (specifically the shear modulus, or resistance of the cervix to shear deformation (kPa), of cervical tissue with extremely high precision. Torsional wave is a type of mechanical wave characterized by a rotational motion and low energy levels (it uses 1000 times less energy than other mechanical waves such as ultrasound). These waves propagate through the tissue, and their propagation speed, which is related to the stiffness (waves propagate faster in stiffer tissues), is measured using piezoelectric sensors.
Transvaginal ultrasoundDevice
Cervicometry measured with transvaginal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Cervisense | Experimental | Cervisense arm: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation. Receives: Device: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation. |
| Control arm (only in Pilot Phase) | Active comparator | Control arm: Cervicometry measured with transvaginal ultrasound Receives: Device: Transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase)
It will be determined in terms of accuracy, specifically with Specificity and Sensitivity as primary endpoints. Cervisense TPTL will be considered effective in screening for preterm birth risk if the validation study demonstrates at least 90% Specificity and 50% Sensitivity in detecting spontaneous preterm birth within the next 7 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labor (TPTL) presenting to the emergency department.
Measured: From enrollment until delivery
Document and analyse all adverse events related to device use (severity, duration, intervention) (Pilot and Pivotal Phases)
To document and analyse all adverse events related to the device use, categorized by severity, duration, and required intervention. Exhaustive monitoring of complications directly attributable to the device or its usage, such as tissue damage or active infection.
Measured: From enrollment until delivery
Technical problems ratio (Pilot Phase)
To report less than 10 technical problems that impeded the physician from performing cervical stiffness measurements
Measured: From enrollment until the use of the device
Probe repeatability (Pilot Phase)
To have an average repeatability rate greater than 75%
Measured: From enrollment until the use of the device
Valid measurements obtained (Pilot Phase)
To achieve more than 80% of valid cases among the measures obtained
Measured: From enrollment until the use of the device
Secondary outcomes (9)
Monitor labour progression indicators (Pilot and Pivotal Phases)
To monitor key indicators of labour progression, such as frequency and intensity of contractions, and foetal descent after using the device to determine based on clinical criteria if there are any significant changes in labour progression indicators that could be attributed to its use.
Measured: From enrollment until the 14-days follow-up
Monitor trauma indicators (e.g., petechiae, bleeding) (Pilot and Pivotal Phases)
To monitor key indicators of potential trauma caused by the device entering the vagina or contacting the cervix, such as bruising (petechiae) or bleeding. Visual evaluation of the vagina and the cervix will be performed before and immediately after the use of the device and any significant changes that could be attributed to its use will be documented.
Measured: From enrollment until the 14-days follow-up
VAS pain score ≤3 (mild/no pain) (Pilot and Pivotal Phases)
To achieve a VAS score attributed to the use of Cervisense Intravaginal Probe V0.1 m≤ 3, which is equivalent to mild or no pain.
Measured: From enrollment until the use of the device
Specificity, Sensitivity, PPV, NPV within 10 and 14 days (Pivotal Phase)
To estimate and report Cervisense TPTL Specificity, Sensitivity, Positive predictive value (PPV) and Negative predictive value (NPV) in screening for spontaneous preterm birth within the next 10 and 14 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labour (TPTL) presenting to the emergency department.
Measured: From enrollment until delivery
Subgroup analysis (gestational age, obstetric history) (Pivotal Phase)
To estimate and report Cervisense TPTL Specificity, Sensitivity, Positive predictive value (PPV) and Negative predictive value (NPV) in screening for spontaneous preterm birth within the next 14 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labour (TPTL) presenting to the emergency department.
Measured: From enrollment until delivery
Training performance (Pivotal Phase)
To evaluate the performance of the device in different subgroups (gestational age, previous pregnancies, previous deliveries previous miscarriages, previous episode of TPTL).
Measured: From enrollment until delivery
Operator satisfaction (SUS) (Pilot and Pivotal Phases)
To measure the operator degree of satisfaction with the Cervisense technique with the SUS (System Usability Scale).
Measured: From enrollment until the use of the device
Comparison with PartoSure and cervical length (at 7, 10, 14 days) (Pivotal Phase)
To compare the Specificity, Sensitivity, Positive predictive value (PPV) and Negative predictive value (NPV) of Cervisense TPTL with the ones obtained with PartoSure test and cervical length within the next 7, 10 and 14 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labour (TPTL) presenting to the emergency department.
Measured: From enrollment until delivery
Degree of success obtained during the use of the Cervisense Intravaginal Probe (Pilot Phase)
To measure the degree of success obtained during the use of Cervisense Intravaginal Probe V0.1: device ID, operator profile and code, number of repetitions, % repeatability of the measurement, incidents and probe cover breakage
Measured: From enrollment until the use of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start10 May 2025 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Threatened 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 457 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ultrasound-Innovation Medtech, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968364
- Sponsor's protocol ID
- FB-CT2
- Acronym
- FB-CT2
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papiernik E, Bouyer J, Collin D, Winisdoerffer G, Dreyfus J. Precocious cervical ripening and preterm labor. Obstet Gynecol. 1986 Feb;67(2):238-42. doi: 10.1097/00006250-198602000-00014.
PubMed 3945433Parra-Saavedra M, Gomez L, Barrero A, Parra G, Vergara F, Navarro E. Prediction of preterm birth using the cervical consistency index. Ultrasound Obstet Gynecol. 2011 Jul;38(1):44-51. doi: 10.1002/uog.9010.
PubMed 21465603Molina FS, Pardo L, Munoz MD, Aiartzaguena A, Valladolid A, Blanco JE, Burgos J, Gil MM. Reproducibility and usability assessment of the novel Fine Birth device for threatened preterm labor diagnosis. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100982. doi: 10.1016/j.ajogmf.2023.100982. Epub 2023 Apr 23.
PubMed 37094638Melchor JC, Navas H, Marcos M, Iza A, De Diego M, Rando D, Melchor I, Burgos J. Predictive performance of PAMG-1 vs fFN test for risk of spontaneous preterm birth in symptomatic women attending an emergency obstetric unit: retrospective cohort study. Ultrasound Obstet Gynecol. 2018 May;51(5):644-649. doi: 10.1002/uog.18892. Epub 2018 Mar 26.
PubMed 28850753Melchor JC, Khalil A, Wing D, Schleussner E, Surbek D. Prediction of preterm delivery in symptomatic women using PAMG-1, fetal fibronectin and phIGFBP-1 tests: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Oct;52(4):442-451. doi: 10.1002/uog.19119. Epub 2018 Sep 4.
PubMed 29920825Masso P, Callejas A, Melchor J, Molina FS, Rus G. In Vivo Measurement of Cervical Elasticity on Pregnant Women by Torsional Wave Technique: A Preliminary Study. Sensors (Basel). 2019 Jul 24;19(15):3249. doi: 10.3390/s19153249.
PubMed 31344796Jackson GM, Ludmir J, Bader TJ. The accuracy of digital examination and ultrasound in the evaluation of cervical length. Obstet Gynecol. 1992 Feb;79(2):214-8. doi: 10.3109/01443619209013646.
PubMed 1731287Horinouchi T, Yoshizato T, Muto M, Fujii M, Kozuma Y, Shinagawa T, Morokuma S, Kakuma T, Ushijima K. Gestational age-related changes in shear wave speed of the uterine cervix in normal pregnancy at 12-35 weeks' gestation. J Perinat Med. 2019 May 27;47(4):393-401. doi: 10.1515/jpm-2018-0250.
PubMed 30817303Holcomb WL Jr, Smeltzer JS. Cervical effacement: variation in belief among clinicians. Obstet Gynecol. 1991 Jul;78(1):43-5.
PubMed 2047066Goldenberg RL, Mercer BM, Meis PJ, Copper RL, Das A, McNellis D. The preterm prediction study: fetal fibronectin testing and spontaneous preterm birth. NICHD Maternal Fetal Medicine Units Network. Obstet Gynecol. 1996 May;87(5 Pt 1):643-8. doi: 10.1016/0029-7844(96)00035-x.
PubMed 8677060Carlson LC, Feltovich H, Palmeri ML, Dahl JJ, Munoz del Rio A, Hall TJ. Estimation of shear wave speed in the human uterine cervix. Ultrasound Obstet Gynecol. 2014 Apr;43(4):452-8. doi: 10.1002/uog.12555. Epub 2014 Mar 12.
PubMed 23836486Callejas A, Gomez A, Faris IH, Melchor J, Rus G. Kelvin-Voigt Parameters Reconstruction of Cervical Tissue-Mimicking Phantoms Using Torsional Wave Elastography. Sensors (Basel). 2019 Jul 25;19(15):3281. doi: 10.3390/s19153281.
PubMed 31349721BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8. No abstract available.
PubMed 14199536
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and the Preterm Birth Predictive Capacity of the Clinical Investigation Device 'Cervisense TPTL': an International Clinical Study
- ClinicalTrials.gov ID
- NCT06968364
- Acronym / sponsor ID
- FB-CT2 / FB-CT2
- Conditions
- Threatened Preterm Labor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 457 participants (estimated)
- Lead sponsor
- Ultrasound-Innovation Medtech, S.L.Industry (pharma, biotech, devices)
- Study start
- 10 May 2025 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 13 May 2025 (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.
The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm labor (TPTL), between 28+0 and 36+6 weeks of gestation. The main questions it aims to answer are:
Does the Cervisense TPTL device predict spontaneous preterm birth within 7 days?
Is the device safe and technically reliable in a hospital setting?
Researchers will conduct a Pilot Study (randomized, dual-arm) followed by a Pivotal Study (single-arm) to assess technical feasibility and predictive performance.
Participants will undergo an intravaginal measurement of cervical stiffness using the Cervisense Intravaginal Probe. They will be followed for 14 days after the assessment to record delivery outcomes and any adverse events.
Detailed description
The study titled "Evaluation of the safety and the preterm birth predictive capacity of the clinical investigation device 'Cervisense TPTL': an international clinical study" is designed to assess both the safety and performance of the Cervisense TPTL device in predicting spontaneous preterm birth. It is being conducted across various Gynaecology, Obstetrics, and Emergency Services in hospitals throughout Spain and Germany.
Cervisense TPTL is the investigational product being evaluated. It includes two components: the Cervisense Intravaginal Probe V0.1, which measures cervical stiffness, and the Fine Birth algorithm, which combines the measurement with clinical data to assess the short-term risk of spontaneous preterm labor.
The device is intended for use in pregnant women showing symptoms of threatened preterm labor (TPTL), with intact amniotic membranes and a single fetus, between 28 weeks and 36 weeks plus 6 days of gestation. Its purpose is to determine the risk of spontaneous preterm birth within the following 7 days.
The clinical investigation is structured in two phases. The pilot study is a randomized, dual-arm, open-label, interventional, multi-centre study conducted in Spain. Participants are randomized 1:1 to receive either the standard of care or the Cervisense evaluation. The pivotal study is non-randomized and single-arm, also open-label and interventional, conducted at a larger scale across multiple centres in both Spain and Germany.
The main goal is to confirm that the device is safe to use and reliable in clinical settings. For safety, all adverse events associated with the use of the device are documented and analyzed in terms of severity, duration, and required intervention. Special attention is given to potential complications such as tissue trauma or infection. To ensure unbiased evaluation, a Clinical Events Committee and a Data Safety Monitoring Board have been established to independently review adverse events and guide study continuation.
Inclusion Criteria:
- Female ≥18 years
- Singleton pregnancy
- Live fetus, 28w+0d-36w+6d GA
- Intact membranes
- Cervical dilatation <2 cm
- Signed informed consent
- Regular uterine contractions (≥8/60 min) (Pivotal only)
Exclusion Criteria:
- Latex allergy
- Prolapsed membranes
- Fetal malformation
- Fetal infection
- Vaginal bleeding (severe or persistent)
- Cervical cerclage
- Müllerian anomalies
- Pessary use
- Regular uterine contractions (reported by patient) (Pilot only)
- History of preterm birth or TPTL (Pilot only)
- Vasa/placenta previa (Pilot only)
- Gastrointestinal or urinary infections (Pivotal only)
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervisense | Experimental | Device: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.Cervisense arm: Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation. |
| Control arm (only in Pilot Phase) | Active comparator | Device: Transvaginal ultrasoundControl arm: Cervicometry measured with transvaginal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female ≥18 years
- Singleton pregnancy
- Live fetus, 28w+0d-36w+6d GA
- Intact membranes
- Cervical dilatation <2 cm
Key exclusion criteria (12 listed)
- Latex allergy
- Prolapsed membranes
- Fetal malformation
- Fetal infection
- Vaginal bleeding (severe or persistent)
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 |
|---|---|---|
| Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation.The Cervisense Intravaginal Probe V0.1 measures cervical stiffness. It is an in-vivo predictive technology that, by using torsional waves, quantifies the mechanical properties (specifically the shear modulus, or resistance of the cervix to shear deformation (kPa), of cervical tissue with extremely high precision. Torsional wave is a type of mechanical wave characterized by a rotational motion and low energy levels (it uses 1000 times less energy than other mechanical waves such as ultrasound). These waves propagate through the tissue, and their propagation speed, which is related to the stiffness (waves propagate faster in stiffer tissues), is measured using piezoelectric sensors. | Device | Cervisense |
| Transvaginal ultrasoundCervicometry measured with transvaginal ultrasound | Device | Control arm (only in Pilot Phase) |
Primary outcome
≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase)
Time frame: From enrollment until delivery
It will be determined in terms of accuracy, specifically with Specificity and Sensitivity as primary endpoints. Cervisense TPTL will be considered effective in screening for preterm birth risk if the validation study demonstrates at least 90% Specificity and 50% Sensitivity in detecting spontaneous preterm birth within the next 7 days of the cervical stiffness measurement among pregnant women with gestational age between 28w+0d and 36w+6d with suspected and symptomatic Threatened Preterm Labor (TPTL) presenting to the emergency department.
Document and analyse all adverse events related to device use (severity, duration, intervention) (Pilot and Pivotal Phases)
Time frame: From enrollment until delivery
To document and analyse all adverse events related to the device use, categorized by severity, duration, and required intervention. Exhaustive monitoring of complications directly attributable to the device or its usage, such as tissue damage or active infection.
Technical problems ratio (Pilot Phase)
Time frame: From enrollment until the use of the device
To report less than 10 technical problems that impeded the physician from performing cervical stiffness measurements
Probe repeatability (Pilot Phase)
Time frame: From enrollment until the use of the device
To have an average repeatability rate greater than 75%
Valid measurements obtained (Pilot Phase)
Time frame: From enrollment until the use of the device
To achieve more than 80% of valid cases among the measures obtained
9 secondary outcomes
Monitor labour progression indicators (Pilot and Pivotal Phases)
Time frame: From enrollment until the 14-days follow-up
Monitor trauma indicators (e.g., petechiae, bleeding) (Pilot and Pivotal Phases)
Time frame: From enrollment until the 14-days follow-up
VAS pain score ≤3 (mild/no pain) (Pilot and Pivotal Phases)
Time frame: From enrollment until the use of the device
Specificity, Sensitivity, PPV, NPV within 10 and 14 days (Pivotal Phase)
Time frame: From enrollment until delivery
Subgroup analysis (gestational age, obstetric history) (Pivotal Phase)
Time frame: From enrollment until delivery
Training performance (Pivotal Phase)
Time frame: From enrollment until delivery
Operator satisfaction (SUS) (Pilot and Pivotal Phases)
Time frame: From enrollment until the use of the device
Comparison with PartoSure and cervical length (at 7, 10, 14 days) (Pivotal Phase)
Time frame: From enrollment until delivery
Degree of success obtained during the use of the Cervisense Intravaginal Probe (Pilot Phase)
Time frame: From enrollment until the use of the device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 3945433Papiernik E, Bouyer J, Collin D, Winisdoerffer G, Dreyfus J. Precocious cervical ripening and preterm labor. Obstet Gynecol. 1986 Feb;67(2):238-42. doi: 10.1097/00006250-198602000-00014.
- Background: PubMed 21465603Parra-Saavedra M, Gomez L, Barrero A, Parra G, Vergara F, Navarro E. Prediction of preterm birth using the cervical consistency index. Ultrasound Obstet Gynecol. 2011 Jul;38(1):44-51. doi: 10.1002/uog.9010.
- Background: PubMed 37094638Molina FS, Pardo L, Munoz MD, Aiartzaguena A, Valladolid A, Blanco JE, Burgos J, Gil MM. Reproducibility and usability assessment of the novel Fine Birth device for threatened preterm labor diagnosis. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100982. doi: 10.1016/j.ajogmf.2023.100982. Epub 2023 Apr 23.
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- Individual participant dataSharing planned: Undecided
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation. and Transvaginal ultrasound in people with Threatened Preterm Labor, run by Ultrasound-Innovation Medtech, S.L. at 14 sites in Spain.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Maroto Ferrer (+34 747 44 15 38, alberto.maroto@innitius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
≥90% Specificity and ≥50% Sensitivity for predicting spontaneous preterm birth within 7 days (Pivotal Phase) (time frame: From enrollment until delivery). The study lists 5 primary outcomes in all. 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 NCT06968364, which also lists 13 linked publications.
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 13 May 2025.